[Federal Register Volume 78, Number 5 (Tuesday, January 8, 2013)]
[Unknown Section]
[Pages 1574-1585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31671]
[[Page 1573]]
Vol. 78
Tuesday,
No. 5
January 8, 2013
Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 78 , No. 5 / Tuesday, January 8, 2013 /
Unified Agenda
[[Page 1574]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Ch. I
25 CFR Ch. V
42 CFR Chs. I, II, III, IV and V
45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII
Regulatory Agenda
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual Regulatory Agenda.
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SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
12866 require the Department semiannually to issue an inventory of
rulemaking actions under development to provide the public a summary of
forthcoming regulatory actions. This information will help the public
more effectively participate in the Department's regulatory activity,
and the Department welcomes comments on any aspect of this agenda.
FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive
Secretary, Department of Health and Human Services, Washington, DC
20201.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) is the Federal Government's principal agency for protecting the
health of all Americans and providing essential human services,
especially for those who are least able to help themselves. The mission
of HHS is to enhance the health and well-being of Americans by
providing for effective health and human services and by fostering
sound, sustained advances in the sciences underlying medicine, public
health, and social services. This agenda presents the rulemaking
activities that the Department expects to undertake in the foreseeable
future to advance this mission. The agenda furthers several
Departmental goals, including strengthening health care; advancing
scientific knowledge and innovation; advancing the health, safety, and
well-being of the American people; increasing efficiency, transparency,
and accountability of HHS programs; and strengthening the Nation's
health and human services infrastructure and workforce.
The purpose of the agenda is to encourage more effective public
participation in the regulatory process. HHS is currently furthering
this goal by engaging in a Department-wide effort to identify ways to
make the rulemaking process more accessible to the general public. This
effort is in response to President Obama's January 18, 2011, Executive
Order 13563, ``Improving Regulation and Regulatory Review,'' which
requires ongoing retrospective review of current agency regulations and
encourages Federal agencies to develop balanced regulations through a
process that ``allows for public participation and an open exchange of
ideas.'' HHS's efforts include continuing to update its main regulatory
Web site to highlight useful information for the public, such as HHS
rules currently open for public comment, and actively encouraging
meaningful public participation in retrospective review and rulemaking
through education and outreach.
The rulemaking abstracts included in this paper issue of the
Federal Register only cover, as required by the Regulatory Flexibility
Act of 1980, those prospective HHS rulemakings likely to have a
significant economic impact on a substantial number of small entities.
The Department's complete Regulatory Agenda is accessible online at
www.reginfo.gov in an interactive format that offers users enhanced
capabilities to obtain information from the agenda's database.
Dated: August 30, 2012.
Jennifer M. Cannistra,
Executive Secretary to the Department.
Substance Abuse and Mental Health Services Administration--Completed
Actions
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Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
265....................... Opioid Drugs in 0930-AA14
Maintenance or
Detoxification Treatment
of Opiate Addiction
(Completion of a Section
610 Review).
------------------------------------------------------------------------
Centers for Disease Control and Prevention--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
266....................... Establishment of Minimum 0920-AA46
Standards for Birth
Certificates.
------------------------------------------------------------------------
Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
Regulation
Sequence No, Title Identifier No.
------------------------------------------------------------------------
267....................... Over-the-Counter (OTC) 0910-AF43
Drug Review--Sunscreen
Products.
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
268....................... Food Labeling; Revision of 0910-AF22
the Nutrition and
Supplement Facts Labels.
269....................... Food Labeling: Serving 0910-AF23
Sizes of Foods That Can
Reasonably Be Consumed in
One Eating Occasion; Dual
Column Labeling; and
Modifying the Reference
Amounts Customarily
Consumed.
270....................... Over-the-Counter (OTC) 0910-AF31
Drug Review--Cough/Cold
(Antihistamine) Products.
271....................... Over-the-Counter (OTC) 0910-AF36
Drug Review--Internal
Analgesic Products.
272....................... Over-the-Counter (OTC) 0910-AF69
Drug Review--Topical
Antimicrobial Drug
Products.
[[Page 1575]]
273....................... Laser Products; Amendment 0910-AF87
to Performance Standard.
274....................... Current Good Manufacturing 0910-AG10
Practice, Hazard
Analysis, and Risk-Based
Preventive Controls for
Food for Animals (Reg
Plan Seq No. 33).
275....................... Over-the-Counter (OTC) 0910-AG12
Drug Review--Pediatric
Dosing for Cough/Cold
Products.
276....................... Electronic Distribution of 0910-AG18
Prescribing Information
for Human Drugs Including
Biological Products.
277....................... Produce Safety Regulation 0910-AG35
(Reg Plan Seq No. 34).
278....................... Hazard Analysis and Risk- 0910-AG36
Based Preventive Controls
(Reg Plan Seq No. 35).
279....................... ``Tobacco Products'' 0910-AG38
Subject to the Federal
Food, Drug, and Cosmetic
Act, as Amended by the
Family Smoking Prevention
and Tobacco Control Act.
280....................... General Hospital and 0910-AG54
Personal Use Devices:
Issuance of Draft Special
Controls Guidance for
Infusion Pumps.
281....................... Requirements for the 0910-AG59
Testing and Reporting of
Tobacco Product
Constituents,
Ingredients, and
Additives.
282....................... Amendments to the Current 0910-AG70
Good Manufacturing
Practice Regulations for
Finished Pharmaceuticals--
Components.
283....................... Use of Symbols in Labeling 0910-AG74
284....................... Requirements for the 0910-AG81
Submission of Data Needed
to Calculate User Fees
for Manufacturers and
Importers of Tobacco
Products.
285....................... Food Labeling: Hard 0910-AG82
Candies and Breath Mints.
286....................... Food Labeling: Serving 0910-AG83
Sizes; Reference Amounts
for Candies.
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References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
Food and Drug Administration--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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287....................... Infant Formula: Current 0910-AF27
Good Manufacturing
Practices; Quality
Control Procedures;
Notification
Requirements; Records and
Reports; and Quality
Factors.
288....................... Over-the-Counter (OTC) 0910-AF33
Drug Review--Cough/Cold
(Combination) Products.
289....................... Unique Device 0910-AG31
Identification (Reg Plan
Seq No. 39).
290....................... Food Labeling: Nutrition 0910-AG56
Labeling for Food Sold in
Vending Machines (Reg
Plan Seq No. 40).
291....................... Food Labeling: Nutrition 0910-AG57
Labeling of Standard Menu
Items in Restaurants and
Similar Retail Food
Establishments (Reg Plan
Seq No. 41).
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References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
Food and Drug Administration--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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292....................... Prescription Drug 0910-AG14
Marketing Act of 1987;
Prescription Drug
Amendments of 1992;
Policies, Requirements,
and Administrative
Procedures (Section 610
Review).
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Food and Drug Administration--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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293....................... Electronic Submission of 0910-AC52
Data From Studies
Evaluating Human Drugs
and Biologics.
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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294....................... Emergency Preparedness 0938-AO91
Requirements for Medicare
Participating Providers
and Suppliers (CMS-3178-
P) (Section 610 Review).
295....................... Changes to the Hospital 0938-AR53
Inpatient and Long-Term
Care Prospective Payment
System for FY 2014 (CMS-
1599-P) (Reg Plan Seq No.
45).
296....................... Changes to the Hospital 0938-AR54
Outpatient Prospective
Payment System and
Ambulatory Surgical
Center Payment System for
CY 2014 (CMS-1601-P) (Reg
Plan Seq No. 46).
297....................... Revisions to Payment 0938-AR56
Policies Under the
Physician Fee Schedule
and Medicare Part B for
CY 2014 (CMS-1600-P) (Reg
Plan Seq No. 47).
298....................... Prospective Payment System 0938-AR62
for Federally Qualified
Health Centers (FQHCs)
(CMS-1443-P) (Section 610
Review) (Reg Plan Seq No.
48).
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References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
[[Page 1576]]
Centers for Medicare & Medicaid Services--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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299....................... Covered Outpatient Drugs 0938-AQ41
(CMS-2345-F) (Section 610
Review).
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Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
300....................... Transparency Reports and 0938-AR33
Reporting of Physician
Ownership of Investment
Interests (CMS-5060-F).
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Centers for Medicare & Medicaid Services--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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301....................... Administrative 0938-AQ13
Simplification: Standard
Unique Identifier for
Health Plans and ICD-10
Compliance Date Delay
(CMS-0040-F) (Completion
of a Section 610 Review).
302....................... Medicare and Medicaid 0938-AQ84
Electronic Health Record
Incentive Program--Stage
2 (CMS-0044-F).
303....................... Proposed Changes to 0938-AR10
Hospital OPPS and CY 2013
Payment Rates; ASC
Payment System and CY
2013 Payment Rates (CMS-
1589-FC) (Completion of a
Section 610 Review).
304....................... Revisions to Payment 0938-AR11
Policies Under the
Physician Fee Schedule
and Part B for CY 2013
(CMS-1590-FC) (Completion
of a Section 610 Review).
305....................... Changes to the Hospital 0938-AR12
Inpatient and Long-Term
Care Prospective Payment
Systems for FY 2013 (CMS-
1588-F) (Completion of a
Section 610 Review).
306....................... Home Health Prospective 0938-AR18
Payment System Rate for
CY 2013 (CMS-1358-F)
(Completion of a Section
610 Review).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Completed Actions
265. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate
Addiction (Completion of a Section 610 Review)
Legal Authority: 21 U.S.C. 823 (9); 42 U.S.C. 257a; 42 U.S.C.
290aa(d); 42 U.S.C. 290dd-2; 42 U.S.C. 300x-23; 42 U.S.C. 300x-27(a);
42 U.S.C. 300y-11
Abstract: This rule would amend the Federal opioid treatment
program regulations. It would modify the dispensing requirements for
buprenorphine and buprenorphine combination products that are approved
by the Food and Drug Administration (FDA) for opioid dependence and
used in federally certified and registered opioid treatment programs.
In particular, this rule would allow opioid treatment programs more
flexibility in dispensing take-home supplies of buprenorphine after the
assessment and documentation of patients' responsibility and stability
to receive opioid addiction treatment medication.
Timetable:
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Action Date FR Cite
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NPRM................................ 06/19/09 74 FR 29153
NPRM Comment Period End............. 08/18/09 .......................
Final Action........................ 12/06/12 77 FR 72752
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Regulatory Flexibility Analysis Required: No.
Agency Contact: Nicholas Reuter, Supervising Public Health Advisor,
Department of Health and Human Services, Substance Abuse and Mental
Health Services Administration, Suite 2-1063, One Choke Cherry Road,
Rockville, MD 20857 Phone: 240 276-2716, Email:
nicholas.reuter@samhsa.hhs.gov.
RIN: 0930-AA14
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Disease Control and Prevention (CDC)
Proposed Rule Stage
266. Establishment of Minimum Standards for Birth Certificates
Legal Authority: 42 U.S.C. 264
Abstract: This proposed rule establishes minimum standards to
improve security related to the use of birth certificates by Federal
agencies for official purposes.
Timetable:
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Action Date FR Cite
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NPRM................................ 03/00/13 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Charles Rothwell, Director, Division of Vital
Statistics, Department of Health and Human Services, Centers for
Disease Control and Prevention, 3311 Toledo Road, Room 7311, M,
Hyattsville, MD 20782, Phone: 301 458-4555.
RIN: 0920-AA46
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Prerule Stage
267. Over-the-Counter (OTC) Drug Review--Sunscreen Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first of
the future actions
[[Page 1577]]
will address the safety of sunscreen active ingredients. The second of
the future actions will address active ingredients reviewed under time
and extent applications.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
ANPRM (Sunscreen and Insect 02/22/07 72 FR 7941
Repellent).
ANPRM Comment Period End............ 05/23/07 .......................
NPRM (UVA/UVB)...................... 08/27/07 72 FR 49070
NPRM Comment Period End............. 12/26/07 .......................
Final Action (UVA/UVB).............. 06/17/11 76 FR 35620
NPRM (Effectiveness)................ 06/17/11 76 FR 35672
NPRM (Effectiveness) Comment Period 09/15/11 .......................
End.
ANPRM (Dosage Forms)................ 06/17/11 76 FR 35669
ANPRM (Dosage Forms) Comment Period 09/15/11 .......................
End.
ANPRM (Safety)...................... 07/00/13 .......................
NPRM (Time and Extent Applications). 09/00/13 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Regulatory Project Manager, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-
9899, Email: david.eng@fda.hhs.gov.
RIN: 0910-AF43
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
268. Food Labeling; Revision of the Nutrition and Supplement Facts
Labels
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is proposing to amend the labeling regulations for
conventional foods and dietary supplements to provide updated nutrition
information on the label to assist consumers in maintaining healthy
dietary practices. If finalized, this rule will modernize the nutrition
information found on the Nutrition Facts label, as well as the format
and appearance of the label.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 07/11/03 68 FR 41507
ANPRM Comment Period End............ 10/09/03 .......................
ANPRM............................... 04/04/05 70 FR 17008
ANPRM Comment Period End............ 06/20/05 .......................
ANPRM............................... 11/02/07 72 FR 62149
ANPRM Comment Period End............ 01/31/08 .......................
NPRM................................ 02/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100
Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1450,
Email: blakeley.fitzpatrick@fda.hhs.gov.
RIN: 0910-AF22
269. Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed in One Eating Occasion; Dual Column Labeling; and Modifying
the Reference Amounts Customarily Consumed
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is proposing to amend its labeling regulations for
foods to provide updated Reference Amounts Customarily Consumed (RACCs)
for certain food categories. If finalized, this rule would provide
consumers with nutrition information based on the amount of food that
is customarily consumed, which would assist consumers in maintaining
healthy dietary practices. In addition to updating certain RACCs, FDA
is also considering amending the definition of single-serving
containers and providing for dual-column labeling, which would provide
nutrition information per serving and per container, for certain
containers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 04/04/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
NPRM................................ 02/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Cherisa Henderson, Nutritionist, Department of
Health and Human Services, Food and Drug Administration, HFS-830, 5100
Paint Branch Parkway, College Park, MD 20740, Phone: 202 402-1450, Fax:
301 436-1191, Email: cherisa.henderson@fda.hhs.gov.
RIN: 0910-AF23
270. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine)
Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: FDA will be proposing a rule to add the common cold
indication to certain over-the-counter (OTC) antihistamine active
ingredients. This proposed rule is the result of collaboration under
the U.S.-Canada Regulatory Cooperation Council (RCC). The objectives of
the RCC monograph alignment working group are to conduct a pilot
program to develop aligned monograph elements for a selected over-the-
counter (OTC) drug category (e.g., aligned directions, warnings,
indications, and conditions of use) and subsequently, develop
recommendations to determine the feasibility of an ongoing mechanism
for alignment in review and adoption of these OTC drug monograph
elements.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record.. 08/25/00 65 FR 51780
Comment Period End.................. 11/24/00 .......................
NPRM (Amendment) (Common Cold)...... 06/00/13 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Chung, Regulatory Health Project Manager,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax:
301 796-9899, Email: mary.chung@fda.hhs.gov.
RIN: 0910-AF31
271. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21
U.S.C. 379e
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses
[[Page 1578]]
acetaminophen safety. The second action addresses products marketed for
children under 2 years old and weight- and age-based dosing for
children's products.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings 12/26/06 71 FR 77314
and Other Labeling).
NPRM Comment Period End............. 05/25/07
Final Action (Required Warnings and 04/29/09 74 FR 19385
Other Labeling).
Final Action (Correction)........... 06/30/09 74 FR 31177
Final Action (Technical Amendment).. 11/25/09 74 FR 61512
NPRM (Amendment) (Acetaminophen).... 08/00/13
NPRM (Amendment) (Pediatric)........ 12/00/13
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Chung, Regulatory Health Project Manager,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax:
301 796-9899, Email: mary.chung@fda.hhs.gov.
RIN: 0910-AF36
272. Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug
Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses consumer hand wash products. The second action
addresses consumer leave-on antiseptic products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Healthcare)................... 06/17/94 59 FR 31402
Comment Period End.................. 12/15/95
NPRM (Consumer Hand Wash Products).. 02/00/13
NPRM (Consumer Leave-on Products)... 07/00/13
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Regulatory Project Manager, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-
9899, Email: david.eng@fda.hhs.gov.
RIN: 0910-AF69
273. Laser Products; Amendment to Performance Standard
Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C.
393
Abstract: FDA is proposing to amend the performance standard for
laser products to achieve closer harmonization between the current
standard and the International Electrotechnical Commission (IEC)
standard for laser products and medical laser products. The proposed
amendment is intended to update FDA's performance standard to reflect
advancements in technology.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: nancy.pirt@fda.hhs.gov.
RIN: 0910-AF87
274. Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals
Regulatory Plan: This entry is Seq. No. 33 in part II of this issue
of the Federal Register.
RIN: 0910-AG10
275. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/
Cold Products
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C.
355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
will propose changes to the final monograph to address safety and
efficacy issues associated with pediatric cough and cold products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/13
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Chung, Regulatory Health Project Manager,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax:
301 796-9899, Email: mary.chung@fda.hhs.gov.
RIN: 0910-AG12
276. Electronic Distribution of Prescribing Information for Human Drugs
Including Biological Products
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360;
21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374;
21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C.
264
Abstract: This rule would require electronic package inserts for
human drug and biological prescription products with limited
exceptions, in lieu of paper, which is currently used. These inserts
contain prescribing information intended for healthcare practitioners.
This would ensure that the information accompanying the product is the
most up-to-date information regarding important safety and efficacy
issues about these products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/13 .......................
------------------------------------------------------------------------
[[Page 1579]]
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Megan Clark-Velez, Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Office of
Policy, WO 32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD
20993, Phone: 301 796-9301, Email: megan.clark@fda.hhs.gov.
RIN: 0910-AG18
277. Produce Safety Regulation
Regulatory Plan: This entry is Seq. No. 34 in part II of this issue
of the Federal Register.
RIN: 0910-AG35
278. Hazard Analysis and Risk-Based Preventive Controls
Regulatory Plan: This entry is Seq. No. 35 in part II of this issue
of the Federal Register.
RIN: 0910-AG36
279. ``Tobacco Products'' Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco
Control Act
Legal Authority: 21 U.S.C. 301 et seq., The Federal Food, Drug, and
Cosmetic Act; Pub. L. 111-31, The Family Smoking Prevention and Tobacco
Control Act
Abstract: The Family Smoking Prevention and Tobacco Control Act
(Tobacco Control Act) provides the Food and Drug Administration (FDA)
authority to regulate cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to
issue regulations deeming other tobacco products to be subject to the
FD&C Act. This proposed rule would deem products meeting the statutory
definition of ``tobacco product'' to be subject to the FD&C Act and
would specify additional restrictions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: May Nelson, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone:
877 287-1373, Fax: 240 276-3904, Email: may.nelson@fda.hhs.gov.
RIN: 0910-AG38
280. General Hospital and Personal Use Devices: Issuance of Draft
Special Controls Guidance for Infusion Pumps
Legal Authority: 21 U.S.C. 351; 21 U.S.C. 360; 21 U.S.C. 360c; 21
U.S.C. 360e; 21 U.S.C. 360j; 21 U.S.C. 371
Abstract: FDA is proposing to amend the classification of infusion
pumps from class II (performance standards) to class II (special
controls). FDA is taking this action to provide reasonable assurance of
the safety and effectiveness of these devices.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: nancy.pirt@fda.hhs.gov.
RIN: 0910-AG54
281. Requirements for the Testing and Reporting of Tobacco Product
Constituents, Ingredients, and Additives
Legal Authority: 21 U.S.C. 301 et seq., 21 U.S.C. 387, The Family
Smoking Prevention and Tobacco Control Act
Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by
the Family Smoking Prevention and Tobacco Control Act, requires the
Food and Drug Administration to promulgate regulations that require the
testing and reporting of tobacco product constituents, ingredients, and
additives, including smoke constituents, that the agency determines
should be tested to protect the public health.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/13 .......................
NPRM Comment Period End............. 06/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Carol Drew, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 9200 Corporate Boulevard, Room 240 H, Rockville, MD
20850, Phone: 877 287-1373, Fax: 240 276-3904, Email:
carol.drew@fda.hhs.gov.
RIN: 0910-AG59
282. Amendments to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals--Components
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C.
262; 42 U.S.C. 264
Abstract: This rule proposes to amend regulations regarding the
control over components used in manufacturing finished pharmaceuticals.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Hasselbalch, Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3279, Email:
brian.hasselbalch@fda.hhs.gov.
Paula Katz, Consumer Safety Officer, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO 51, Room 1320, 10903 New Hampshire Avenue, Silver Spring,
MD 20993, Phone: 301 796-6972, Email: paula.katz@fda.hhs.gov.
RIN: 0910-AG70
283. Use of Symbols in Labeling
Legal Authority: Sec 502(c) of the Food Drug and Cosmetic Act (FD&C
Act), 21 U.S.C. 352(c); sec 514(c) of FD&C Act, 21 U.S.C. 360d(c),
enacted by the Food and Drug Modernization Act of 1997 (FDAMA)
Abstract: The purpose of this proposed rule is to implement section
502(c) of the FD&C Act and to revise 21 CFR 801.15 (prominence of
required label statements) using the authority under section 514(c) of
the FD&C Act to allow for the inclusion of certain standardized symbols
recognized by FDA for use on the labeling of medical devices. If this
proposed rule is finalized, certain symbols in compliance with
International Standards Organization (ISO) Standard 15223 may be used
in medical device labeling with explanatory text or symbols glossary
with accompanying labeling, as may other standardized symbols in the
future when adopted by a national or international standards
development organization and if recognized by FDA guidance or other
regulatory action.
[[Page 1580]]
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Follette Story, Human Factors and Accessible
Medical Technology Specialist, Department of Health and Human Services,
Food and Drug Administration, Center for Devices and Radiological
Health, Room 2553, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone: 301 796-1456, Email: molly.story@fda.hhs.gov.
RIN: 0910-AG74
284. Requirements for the Submission of Data Needed To Calculate User
Fees for Manufacturers and Importers of Tobacco Products
Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; PL111-31
Abstract: FDA is proposing to require manufacturers and importers
of tobacco products to submit certain market share data to FDA. USDA
currently collects such data, but its program sunsets at the end of
September 2014 and USDA will cease collection of this information. FDA
is taking this action so that it may continue to calculate market share
percentages needed to compute user fees.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Annette L. Marthaler, Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Tobacco Products, 9200 Corporate Boulevard, Room 340K,
Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email:
annette.marthaler@fda.hhs.gov.
RIN: 0910-AG81
285. Food Labeling: Hard Candies and Breath Mints
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is proposing to change the nutrition label serving
size for breath mints to one mint. FDA is taking this action in
response to comments received on an advance notice of proposed
rulemaking published in 2005.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/30/97 62 FR 67775
NPRM Comment Period End............. 03/16/98 .......................
ANPRM............................... 04/05/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
NPRM................................ 02/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mark Kantor, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, 5100 Paint Branch
Parkway, HFS-830, College Park, MD 20740, Phone: 240 402-1450, Fax: 301
436-1191, Email: mark.kantor@fda.hhs.gov.
RIN: 0910-AG82
286. Food Labeling: Serving Sizes; Reference Amounts for Candies
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is proposing to change its serving size regulations
to provide updated Reference Amounts Customarily Consumed for candies.
FDA is taking this action in response to comments received on an
advance notice of proposed rulemaking published in 2005.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/08/98 63 FR 1078
NPRM Comment Period End............. 02/09/98 .......................
ANPRM............................... 04/05/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
NPRM................................ 02/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mark Kantor, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, 5100 Paint Branch
Parkway, HFS-830, College Park, MD 20740, Phone: 240 402-1450, Fax: 301
436-1191, Email: mark.kantor@fda.hhs.gov.
RIN: 0910-AG83
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
287. Infant Formula: Current Good Manufacturing Practices; Quality
Control Procedures; Notification Requirements; Records and Reports; and
Quality Factors
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 350a; 21
U.S.C. 371
Abstract: The Food and Drug Administration (FDA) is revising its
infant formula regulations in 21 CFR parts 106 and 107 to establish
requirements for current good manufacturing practices (CGMP), including
audits; to establish requirements for quality factors; and to amend
FDA's quality control procedures, notification, and record and
reporting requirements for infant formula. FDA is taking this action to
improve the protection of infants who consume infant formula products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/09/96 61 FR 36154
NPRM Comment Period End............. 12/06/96 .......................
NPRM Comment Period Reopened........ 04/28/03 68 FR 22341
NPRM Comment Period Extended........ 06/27/03 68 FR 38247
NPRM Comment Period End............. 08/26/03 .......................
NPRM Comment Period Reopened........ 08/01/06 71 FR 43392
NPRM Comment Period End............. 09/15/06 .......................
Final Rule.......................... 04/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Benson Silverman, Staff Director, Infant Formula
and Medical Foods, Department of Health and Human Services, Food and
Drug Administration, Center for Food Safety and Applied Nutrition (HFS-
850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240
402-1459, Email: benson.silverman@fda.hhs.gov.
RIN: 0910-AF27
288. Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination)
Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
[[Page 1581]]
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses cough/cold drug products containing an oral bronchodilator
(ephedrine and its salts) in combination with any expectorant or any
oral nasal decongestant.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment).................... 07/13/05 70 FR 40232
NPRM Comment Period End............. 11/10/05 .......................
Final Action (Technical Amendment).. 03/19/07 72 FR 12730
Final Action........................ 03/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Chung, Regulatory Health Project Manager,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax:
301 796-9899, Email: mary.chung@fda.hhs.gov.
RIN: 0910-AF33
289. Unique Device Identification
Regulatory Plan: This entry is Seq. No. 39 in part II of this issue
of the Federal Register.
RIN: 0910-AG31
290. Food Labeling: Nutrition Labeling for Food Sold in Vending
Machines
Regulatory Plan: This entry is Seq. No. 40 in part II of this issue
of the Federal Register.
RIN: 0910-AG56
291. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments
Regulatory Plan: This entry is Seq. No. 41 in part II of this issue
of the Federal Register.
RIN: 0910-AG57
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
292. Prescription Drug Marketing Act of 1987; Prescription Drug
Amendments of 1992; Policies, Requirements, and Administrative
Procedures (Section 610 Review)
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351 to
353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381
Abstract: FDA is currently reviewing regulations promulgated under
the Prescription Drug Marketing Act (PDMA). FDA is undertaking this
review to determine whether the regulations should be changed or
rescinded to minimize adverse impacts on a substantial number of small
entities. FDA has extended again the completion date by 1 year and will
complete the review by December 2013.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation.. 11/24/08 .......................
End Review of Current Regulation.... 12/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Howard Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601,
Fax: 301 847-8440, Email: pdma610(c)review@fda.hhs.gov.
RIN: 0910-AG14
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
293. Electronic Submission of Data From Studies Evaluating Human Drugs
and Biologics
Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262
Abstract: The Food and Drug Administration is proposing to amend
the regulations governing the format in which clinical study data and
bioequivalence data are required to be submitted for new drug
applications (NDAs), biological license applications (BLAs), and
abbreviated new drug applications (ANDAs). The proposal would revise
our regulations to require that data submitted for NDAs, BLAs, and
ANDAs, and their supplements and amendments, be provided in an
electronic format that FDA can process, review, and archive.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 08/01/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Martha Nguyen, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3471, Fax: 301
847-8440, Email: martha.nguyen@fda.hhs.gov.
RIN: 0910-AC52
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
294. Emergency Preparedness Requirements for Medicare Participating
Providers and Suppliers (CMS-3178-P) (Section 610 Review)
Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861(ff)(3)(B)(i)(ii);
42 U.S.C. 1913(c)(1) et al.
Abstract: This rule proposes emergency preparedness requirements
for Medicare and Medicaid participating providers and suppliers to
ensure that they adequately plan for both natural and man-made
disasters and coordinate with Federal, state, tribal, regional and
local emergency preparedness systems. This rule will ensure providers
and suppliers are adequately prepared to meet the needs of patients,
residents, clients, and participants during disasters and emergency
situations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Graham, Health Insurance Specialist, Clincal
Standards Group, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Office of
[[Page 1582]]
Clincial Standards and Quality, Mail Stop S3-02-01, 7500 Security
Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-8020, Email:
janice.graham@cms.hhs.gov.
RIN: 0938-AO91
295. Changes to the Hospital Inpatient and Long-Term Care
Prospective Payment System for FY 2014 (CMS-1599-P)
Regulatory Plan: This entry is Seq. No. 45 in part II of this issue
of the Federal Register.
RIN: 0938-AR53
296. Changes to the Hospital Outpatient Prospective Payment
System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-
1601-P)
Regulatory Plan: This entry is Seq. No. 46 in part II of this issue
of the Federal Register.
RIN: 0938-AR54
297. Revisions to Payment Policies Under the Physician Fee
Schedule and Medicare Part B for CY 2014 (CMS-1600-P)
Regulatory Plan: This entry is Seq. No. 47 in part II of this issue
of the Federal Register.
RIN: 0938-AR56
298. Prospective Payment System for Federally Qualified Health
Centers (FQHCS) (CMS-1443-P) (Section 610 Review)
Regulatory Plan: This entry is Seq. No. 48 in part II of this issue
of the Federal Register.
RIN: 0938-AR62
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
299. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)
Legal Authority: Pub. L. 111- 48, secs 2501, 2503, 3301(d)(2); Pub.
L. 111-152, sec 1206; Pub. L. 111-8, sec 221
Abstract: This final rule revises requirements pertaining to
Medicaid reimbursement for covered outpatient drugs to implement
provisions of the Affordable Care Act. This rule also revises other
requirements related to covered outpatient drugs, including key aspects
of Medicaid coverage, payment, and the drug rebate program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/02/12 77 FR 5318
NPRM Comment Period End............. 04/02/12 .......................
Final Action........................ 08/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Wendy Tuttle, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicaid and State Operations, Mail Stop
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8690, Email: wendy.tuttle@cms.hhs.gov.
RIN: 0938-AQ41
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
300. Transparency Reports and Reporting of Physician Ownership of
Investment Interests (CMS-5060-F)
Legal Authority: Pub. L. 111-148, sec 6002
Abstract: This final rule requires applicable manufacturers of
drugs, devices, biologicals, or medical supplies covered by Medicare,
Medicaid, or CHIP to annually report to the Secretary certain payments
or transfers of value provided to physicians or teaching hospitals
(covered recipients). In addition, applicable manufacturers and
applicable group purchasing organizations (GPOs) are required to
annually report certain physician ownership or investment interests.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/19/11 76 FR 78742
NPRM Comment Period End............. 02/17/12 .......................
Final Action........................ 12/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Niall Brennan, Director, Policy and Data Analysis
Group, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone:
202 690-6627, Email: niall.brennan@cms.hhs.gov.
RIN: 0938-AR33
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
301. Administrative Simplification: Standard Unique Identifier for
Health Plans and ICD-10 Compliance Date Delay (CMS-0040-F) (Completion
of a Section 610 Review)
Legal Authority: Pub. L. 111-148, sec 1104
Abstract: This rule implements provisions of the Affordable Care
Act of 2010 under Administrative Simplification that establish a unique
health plan identifier. This health plan identifier will be used to
identify health plans in HIPAA standard transactions. The rule also
finalizes a delay to comply with ICD-10.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/17/12 77 FR 22950
NPRM Comment Period End............. 05/17/12 .......................
Final Action........................ 09/05/12 77 FR 54664
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Christine Stahlecker, Acting Director,
Administrative Simplification Group, Office of E-Health Standards and
Services, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Mail Stop S2-26-17, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-6405, Email:
christine.stahlecker@cms.hhs.gov.
RIN: 0938-AQ13
302. Medicare and Medicaid Electronic Health Record Incentive Program--
Stage 2 (CMS-0044-F)
Legal Authority: Pub. L. 111-5 secs 4101, 4102, and 4202
Abstract: The final rule expands the criteria for meaningful use
established for Stage 1 to advance the use of certified EHR technology
by eligible professionals, eligible hospitals and critical access
hospitals (CAHs). This rule is economically significant. The rule
establishes the requirements for Stage 2, which encourages the use of
continuous quality improvement at the point of care, and the exchange
of information in the most structured format possible. For example, the
electronic transmission of orders entered using computerized provider
order entry, and the electronic transmission of diagnostic test
results.
Timetable:
[[Page 1583]]
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/07/12 77 FR 13698
NPRM Comment Period End............. 05/07/12
Final Action........................ 09/04/12 77 FR 53967
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Elizabeth Holland, Director, Health Initiatives
Group/Office of E-Health Standards and Services, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Mail Stop
S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
1309, Email: elizabeth.holland@cms.hhs.gov.
RIN: 0938-AQ84
303. Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC
Payment System and CY 2013 Payment Rates (CMS-1589-FC) (Completion of a
Section 610 Review)
Legal Authority: Sec 1833 of the Social Security Act
Abstract: This final rule revises the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system. The rule also describes changes to the amounts and factors
used to determine payment rates for services. In addition, the rule
implements changes to the Ambulatory Surgical Center Payment System
list of services and rates.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/30/12 77 FR 45061
NPRM Comment Period End............. 09/04/12
Final Action........................ 11/15/12 77 FR 68210
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Marjorie Baldo, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare Management, 7500 Security
Boulevard, C4-03-06, Baltimore, MD 21244, Phone: 410 786-4617, Email:
marjorie.baldo@cms.hhs.gov.
RIN: 0938-AR10
304. Revisions to Payment Policies Under the Physician Fee Schedule and
Part B for CY 2013 (CMS-1590-FC) (Completion of a Section 610 Review)
Legal Authority: Social Security Act, secs 1102, 1871, 1848
Abstract: This annual final rule revises payment polices under the
physician fee schedule, as well as other policy changes to payment
under Part B. These changes are applicable to services furnished on or
after January 1.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/30/12 77 FR 44721
NPRM Comment Period End............. 09/04/12
Final Action........................ 11/16/12 77 FR 68892
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Christina Ritter, Director, Division of
Practitioner Services, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Mail Stop C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-4636, Email:
christina.ritter@cms.hhs.gov.
RIN: 0938-AR11
305. Changes to the Hospital Inpatient and Long-Term Care Prospective
Payment Systems for FY 2013 (CMS-1588-F) (Completion of a Section 610
Review)
Legal Authority: Sec 1886(d) of the Social Security Act, Pub. L.
111-148, secs 3025, 5506, 3005
Abstract: This annual final rule revises the Medicare hospital
inpatient and long-term care hospital prospective payment systems for
operating and capital-related costs. This rule implements changes
arising from our continuing experience with these systems.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/11/12 77 FR 27870
NPRM Comment Period End............. 06/25/12
Final Action........................ 08/31/12 77 FR 53257
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Slater, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-5229, Email:
brian.slater@cms.hhs.gov.
RIN: 0938-AR12
306. Home Health Prospective Payment System Rate for CY 2013 (CMS-1358-
F) (Completion of a Section 610 Review)
Legal Authority: Social Security Act, secs 1102 and 1871; 42 U.S.C.
1302 and 42 U.S.C. 1395(hh); Social Security Act, sec 1895; 42 U.S.C.
1395(fff)
Abstract: This final rule updates the 60-day national episode rate
based on the applicable home health market basket update and case-mix
adjustment. It also updates the national per-visit rates used to
calculate low utilization payment adjustments (LUPAs) and outlier
payments under the Medicare prospective payment system for home health
agencies. These changes are applicable to services furnished on or
after January 1.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/13/12 77 FR 41547
NPRM Comment Period End............. 09/04/12
Final Action........................ 11/08/12 77 FR 67068
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Hillary Loeffler, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mailstop C5-08-28, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-0456, Email:
hillary.loeffler@cms.hhs.gov.
RIN: 0938-AR18
[FR Doc. 2012-31671 Filed 1-7-13; 8:45 am]
BILLING CODE 4150-24-P