[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Proposed Rules]
[Pages 40052-40073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15487]





[[Page 40051]]



Vol. 76



Thursday,



No. 130



July 7, 2011



Part VIII











Department of Health and Human Services











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Semiannual Regulatory Agenda



  Federal Register / Vol. 76 , No. 130 / Thursday, July 7, 2011 / 

Unified Agenda  



[[Page 40052]]





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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Office of the Secretary



21 CFR Ch. I



42 CFR Chs. I-V



45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII




Regulatory Agenda



AGENCY: Office of the Secretary, HHS.



ACTION: Semiannual Regulatory Agenda.



-----------------------------------------------------------------------



SUMMARY: The following Agenda presents the results of the statutorily 

required semi-annual inventory of rulemaking actions currently under 

development within the U.S. Department of Health and Human Services. We 

hope that this information will enable interested members of the public 

to more effectively participate in the Department's regulatory 

activity.



FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary, 

Department of Health and Human Services, Washington, DC 20201.



SUPPLEMENTARY INFORMATION: The information provided in the Agenda 

presents a forecast of the rulemaking activities that the Department of 

Health and Human Services (HHS) expects to undertake in the foreseeable 

future. Rulemakings are grouped according to pre-rulemaking actions, 

proposed rules, final rules, long-term actions, and rulemaking actions 

completed since the most recent Agenda was published on December 20, 

2010. Please note that the actions included in this issue of the 

Federal Register, as required by the Regulatory Flexibility Act of 

1980, relate only to those prospective rulemakings that are likely to 

have a significant economic impact on a substantial number of small 

entities.

    Consistent with Executive Order 13563, the purpose of the Agenda is 

to encourage more effective public participation in the regulatory 

process. HHS invites all interested members of the public to comment on 

the rulemaking actions included in this issuance of the Agenda 

including comments on whether any of these or related rulemaking 

actions should be modified, streamlined, expanded, or repealed in order 

to make the agency's regulatory program more effective or less 

burdensome in achieving regulatory objectives. The complete Agenda is 

accessible online at http://www.reginfo.gov in an interactive format 

that offers users enhanced capabilities to obtain information from the 

Agenda's database.



    Dated: April 4, 2011.

Dawn L. Smalls,

Executive Secretary, Department of Health and Human Services.



               Office of the Secretary--Completed Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

138.......................  Modifications to the HIPAA         0991-AB57

                             Privacy, Security, and

                             Enforcement Rules Under

                             the Health Information

                             Technology for Economic

                             and Clinical Health Act.

------------------------------------------------------------------------





    Office of Consumer Information and Insurance Oversight--Completed

                                 Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

139.......................  Status as a Grandfathered          0950-AA17

                             Health Plan Under the

                             Affordable Care Act.

------------------------------------------------------------------------





  Substance Abuse and Mental Health Services Administration--Final Rule

                                  Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

140.......................  Opioid Drugs in                    0930-AA14

                             Maintenance or

                             Detoxification Treatment

                             of Opiate Addiction

                             (Section 610 Review).

------------------------------------------------------------------------





  Substance Abuse and Mental Health Services Administration--Long-Term

                                 Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

141.......................  Requirements Governing the         0930-AA10

                             Use of Seclusion and

                             Restraint in Certain

                             Nonmedical Community-

                             Based Facilities for

                             Children and Youth.

------------------------------------------------------------------------





      Centers for Disease Control and Prevention--Final Rule Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

142.......................  Control of Communicable            0920-AA12

                             Diseases: Foreign and

                             Possessions.

143.......................  Control of Communicable            0920-AA22

                             Diseases: Interstate.

------------------------------------------------------------------------





[[Page 40053]]





      Centers for Disease Control and Prevention--Completed Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

144.......................  Quality Assurance                  0920-AA04

                             Requirements for

                             Respirators.

------------------------------------------------------------------------





               Food and Drug Administration--Prerule Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

145.......................  Prescription Drug                  0910-AG14

                             Marketing Act of 1987;

                             Prescription Drug

                             Amendments of 1992;

                             Policies, Requirements,

                             and Administrative

                             Procedures (Section 610

                             Review).

146.......................  Requirements for Testing           0910-AG61

                             Human Blood Donors for

                             Evidence of Infection Due

                             to Communicable Disease

                             Agents (Section 610

                             Review).

147.......................  General Requirements for           0910-AG62

                             Blood, Blood Components,

                             and Blood Derivatives;

                             Donor Notification

                             (Section 610 Review).

------------------------------------------------------------------------





            Food and Drug Administration--Proposed Rule Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

148.......................  Electronic Submission of           0910-AC52

                             Data From Studies

                             Evaluating Human Drugs

                             and Biologics.

149.......................  Over-the-Counter (OTC)             0910-AF36

                             Drug Review--Internal

                             Analgesic Products.

150.......................  Over-the-Counter (OTC)             0910-AF40

                             Drug Review--Oral Health

                             Care Products.

151.......................  Over-the-Counter (OTC)             0910-AF43

                             Drug Review--Sunscreen

                             Products.

152.......................  Over-the-Counter (OTC)             0910-AF45

                             Drug Review--Weight

                             Control Products.

153.......................  Over-the-Counter (OTC)             0910-AF69

                             Drug Review--Topical

                             Antimicrobial Drug

                             Products.

154.......................  Import Tolerances for              0910-AF78

                             Residues of Unapproved

                             New Animal Drugs in Food.

155.......................  Laser Products; Amendment          0910-AF87

                             to Performance Standard.

156.......................  Pet Food Labeling                  0910-AG09

                             Requirements.

157.......................  Current Good Manufacturing         0910-AG10

                             Practice in

                             Manufacturing,

                             Processing, Packing or

                             Holding Animal Food.

158.......................  Over-the-Counter (OTC)             0910-AG12

                             Drug Review--Pediatric

                             Dosing for Cough/Cold

                             Products.

159.......................  Electronic Distribution of         0910-AG18

                             Content of Labeling for

                             Human Prescription Drug

                             and Biological Products.

160.......................  Unique Device                      0910-AG31

                             Identification.

161.......................  Produce Safety Regulation.         0910-AG35

162.......................  Hazard Analysis and Risk-          0910-AG36

                             Based Preventive Controls.

163.......................  ``Tobacco Products''               0910-AG38

                             Subject to the Federal

                             Food, Drug, and Cosmetic

                             Act, as Amended by the

                             Family Smoking Prevention

                             and Tobacco Control Act.

164.......................  General Hospital and               0910-AG54

                             Personal Use Devices:

                             Issuance of Draft Special

                             Controls Guidance for

                             Infusion Pumps.

165.......................  Food Labeling: Nutrition           0910-AG56

                             Labeling for Food Sold in

                             Vending Machines.

166.......................  Food Labeling: Nutrition           0910-AG57

                             Labeling of Standard Menu

                             Items in Restaurants and

                             Similar Retail Food

                             Establishments.

167.......................  Requirements for the               0910-AG59

                             Testing and Reporting of

                             Tobacco Product

                             Constituents,

                             Ingredients, and

                             Additives.

168.......................  Further Amendments to              0910-AG60

                             General Regulations of

                             the Food and Drug

                             Administration to

                             Incorporate Tobacco

                             Products.

------------------------------------------------------------------------





             Food and Drug Administration--Final Rule Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

169.......................  Infant Formula: Current            0910-AF27

                             Good Manufacturing

                             Practices; Quality

                             Control Procedures;

                             Notification

                             Requirements; Records and

                             Reports; and Quality

                             Factors.

170.......................  Over-the-Counter (OTC)             0910-AF32

                             Drug Review--Cough/Cold

                             (Bronchodilator) Products.

171.......................  Over-the-Counter (OTC)             0910-AF33

                             Drug Review--Cough/Cold

                             (Combination) Products.

172.......................  Use of Materials Derived           0910-AF47

                             From Cattle in Human Food

                             and Cosmetics.

173.......................  Label Requirement for Food         0910-AF61

                             That Has Been Refused

                             Admission Into the United

                             States.

174.......................  Cigarette Warning Label            0910-AG41

                             Statements.

------------------------------------------------------------------------





             Food and Drug Administration--Long-Term Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

175.......................  Postmarketing Safety               0910-AA97

                             Reporting Requirements

                             for Human Drug and

                             Biological Products.

176.......................  Current Good Manufacturing         0910-AB88

                             Practice in

                             Manufacturing, Packing,

                             Labeling, or Holding

                             Operations for Dietary

                             Supplements.

177.......................  Medical Gas Containers and         0910-AC53

                             Closures; Current Good

                             Manufacturing Practice

                             Requirements.



[[Page 40054]]



 

178.......................  Content and Format of              0910-AF11

                             Labeling for Human

                             Prescription Drugs and

                             Biologics; Requirements

                             for Pregnancy and

                             Lactation Labeling.

179.......................  Over-the-Counter (OTC)             0910-AF31

                             Drug Review--Cough/Cold

                             (Antihistamine) Products.

180.......................  Over-the-Counter (OTC)             0910-AF35

                             Drug Review--External

                             Analgesic Products.

181.......................  Over-the-Counter (OTC)             0910-AF38

                             Drug Review--Laxative

                             Drug Products.

------------------------------------------------------------------------





             Food and Drug Administration--Completed Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

182.......................  Over-the-Counter (OTC)             0910-AF34

                             Drug Review--Cough/Cold

                             (Nasal Decongestant)

                             Products.

183.......................  Over-the-Counter (OTC)             0910-AF37

                             Drug Review--Labeling of

                             Drug Products for OTC

                             Human Use.

184.......................  Over-the-Counter (OTC)             0910-AF39

                             Drug Review--Ophthalmic

                             Products.

185.......................  Over-the-Counter (OTC)             0910-AF42

                             Drug Review--Skin

                             Protectant Products.

186.......................  Over-the-Counter (OTC)             0910-AF44

                             Drug Review--Vaginal

                             Contraceptive Products.

187.......................  Over-the-Counter (OTC)             0910-AF51

                             Drug Review--

                             Overindulgence in Food

                             and Drink Products.

188.......................  Over-the-Counter (OTC)             0910-AF52

                             Drug Review--Antacid

                             Products.

189.......................  Over-the-Counter (OTC)             0910-AF53

                             Drug Review--Skin

                             Bleaching Products.

190.......................  Over-the-Counter (OTC)             0910-AF56

                             Drug Review--Stimulant

                             Drug Products.

191.......................  Over-the-Counter (OTC)             0910-AF63

                             Drug Review--

                             Antidiarrheal Drug

                             Products.

192.......................  Over-the-Counter (OTC)             0910-AF70

                             Drug Review--Urinary

                             Analgesic Drug Products.

193.......................  Over-the-Counter (OTC)             0910-AF95

                             Drug Review--Certain

                             Category II Active

                             Ingredients.

194.......................  Food Labeling: Safe                0910-AG06

                             Handling Statements,

                             Labeling of Shell Eggs;

                             Refrigeration of Shell

                             Eggs Held for Retail

                             Distribution (Section 610

                             Review).

------------------------------------------------------------------------





         Centers for Medicare & Medicaid Services--Prerule Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

195.......................  Five Year Review of Work           0938-AQ87

                             Relative Value Units

                             Under the Physician Fee

                             Schedule (CMS-1582-PN).

------------------------------------------------------------------------





      Centers for Medicare & Medicaid Services--Proposed Rule Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

196.......................  Home Health Agency (HHA)           0938-AG81

                             Conditions of

                             Participation (CoPs) (CMS-

                             3819-P) (Section 610

                             Review).

197.......................  Influenza Vaccination              0938-AP92

                             Standard for Certain

                             Medicare Participating

                             Providers and Suppliers

                             (CMS-3213-P).

198.......................  Hospital Conditions of             0938-AP97

                             Participation:

                             Requirements for Hospital

                             Inpatient Psychiatric and

                             Rehabilitation Units

                             Excluded From the

                             Prospective Payment

                             System and LTCH

                             Requirements (CMS-3177-P).

199.......................  Proposed Changes to the            0938-AQ24

                             Hospital Inpatient

                             Prospective Payment

                             Systems for Acute Care

                             Hospitals and FY 2012

                             Rates and to the Long-

                             Term Care Hospital PPS

                             and FY 2012 Rates (CMS-

                             1518-P).

200.......................  Changes to the Hospital            0938-AQ26

                             Outpatient Prospective

                             Payment System and

                             Ambulatory Surgical

                             Center Payment System for

                             CY 2012 (CMS-1525-P).

201.......................  Changes to the ESRD                0938-AQ27

                             Prospective Payment

                             System for CY 2012 &

                             Quality Incentives

                             Program for CY 2013 (CMS-

                             1577-P).

202.......................  Medicaid Program                   0938-AQ61

                             Integrity: Registration

                             of Billing Agents,

                             Clearing Houses, or Other

                             Alternate Payees (CMS-

                             2365-P).

203.......................  Medicaid Eligibility               0938-AQ62

                             Expansion Under the

                             Affordable Care Act of

                             2010 (CMS-2349-P).

204.......................  Payments for Primary Care          0938-AQ63

                             Services Under the

                             Medicaid Program (CMS-

                             2370-P).

205.......................  Medicare and Medicaid              0938-AQ84

                             Electronic Health Record

                             Incentive Program--Stage

                             2 (CMS-0044-P).

------------------------------------------------------------------------





       Centers for Medicare & Medicaid Services--Final Rule Stage

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

206.......................  Enhanced Federal Funding           0938-AQ53

                             for Medicaid Eligibility

                             Determination and

                             Enrollment Activities

                             (CMS-2346-F).

------------------------------------------------------------------------





[[Page 40055]]





       Centers for Medicare & Medicaid Services--Long-Term Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

207.......................  Requirements for Long-Term         0938-AP32

                             Care Facilities: Hospice

                             Services (CMS-3140-F)

                             (Section 610 Review).

------------------------------------------------------------------------





       Centers for Medicare & Medicaid Services--Completed Actions

------------------------------------------------------------------------

                                                           Regulation

       Sequence No.                    Title             Identifier No.

------------------------------------------------------------------------

208.......................  Amendment to Payment               0938-AP79

                             Policies Under the

                             Physician Fee Schedule

                             and Part B for CY 2011

                             (CMS-1503-F2).

209.......................  Changes to the Hospital            0938-AP82

                             Outpatient Prospective

                             Payment System and

                             Ambulatory Surgical

                             Center Payment System for

                             CY 2011 (CMS-1504-FC).

210.......................  Section 508 Hospitals--            0938-AQ97

                             Medicare and Medicaid

                             Extenders Act of 2010

                             Changes (CMS-1357-N).

------------------------------------------------------------------------





DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Office of the Secretary (OS)



Completed Actions



138. Modifications to the HIPAA Privacy, Security, and Enforcement 

Rules Under the Health Information Technology for Economic and Clinical 

Health Act



    Legal Authority: Pub. L. 111-5, secs 13400 to 13410

    Abstract: The Department of Health and Human Services, Office for 

Civil Rights, will issue rules to modify the HIPAA Privacy, Security, 

and Enforcement Rules as necessary to implement the privacy, security, 

and certain enforcement provisions of subtitle D of the Health 

Information Technology for Economic and Clinical Health Act (title XIII 

of the American Recovery and Reinvestment Act of 2009).

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   07/14/10  75 FR 40867

NPRM Comment Period End.............   09/13/10  .......................

Merged With 0991-AB80...............   03/02/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Andra Wicks, Privacy Specialist, Office of Civil 

Rights, Department of Health and Human Services, 200 Independence 

Avenue, SW., Washington, DC 20201, Phone: 202 205-2292, Fax: 202 205-

4786, E-mail: [email protected].

    RIN: 0991-AB57



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Office of Consumer Information and Insurance Oversight (OCIIO)



Completed Actions



139. Status as a Grandfathered Health Plan Under the Affordable Care 

Act



    Legal Authority: Pub. L. 111-148

    Abstract: The Affordable Care Act protects the ability of 

individuals and businesses to keep their current plan while providing 

important consumer protections. The new regulation also provides 

stability and flexibility to insurers and businesses that offer health 

insurance coverage as the nation transitions to a more competitive 

marketplace. In 2014, businesses and consumers will have more 

affordable choices through exchanges. This rule would finalize the 

requirements for group health plans and health insurance coverage in 

the group and individual markets and respond to any comments as the 

result of the interim final rule implementing this provision.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Interim Final Rule..................   06/17/10  75 FR 34538

Interim Final Rule Effective........   07/12/10  .......................

Interim Final Rule Comment Period      08/16/10  .......................

 End.

Merged With 0938-AQ80...............   02/11/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: James Mayhew, Director, Division of Market Rules 

Compliance Office, Department of Health and Human Services, Office of 

Consumer Information and Insurance Oversight, Mail Stop C2-12016, 7500 

Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9244, E-mail: 

[email protected].

    RIN: 0950-AA17



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Substance Abuse and Mental Health Services Administration (SAMHSA)



Final Rule Stage



140. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate 

Addiction (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. 300xx-23; 42 U.S.C. 300x-27(a); 

42 U.S.C. 300y-11

    Abstract: This rule will amend the Federal opioid treatment program 

regulations. It will 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.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   06/19/09  74 FR 29153

NPRM Comment Period End.............   08/18/09  .......................

Final Action........................   12/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: No.

    Agency Contact: Nicholas Reuter, 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, E-mail: [email protected].

    RIN: 0930-AA14





[[Page 40056]]







DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Substance Abuse and Mental Health Services Administration (SAMHSA)



Long-Term Actions



141. Requirements Governing the Use of Seclusion and Restraint in 

Certain Nonmedical Community-Based Facilities for Children and Youth



    Legal Authority: Pub. L. 106-310, 42 U.S.C. 290jj to 290jj-2

    Abstract: The Secretary is required by statute to publish 

regulations governing States that license nonmedical, community-based 

residential facilities for children and youth. The regulation requires 

States to develop licensing rules and monitoring requirements 

concerning behavior management practice that will ensure compliance; 

requires States to develop and implement such licensing rules and 

implementation requirements within one year; and ensures that States 

require such facilities to have adequate staff, and that the States 

provide training for professional staff.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Paolo Del Vecchio, Associate Director for Consumer 

Affairs, Department of Health and Human Services, Substance Abuse and 

Mental Health Services Administration, Room 13-103, Parklawn Building, 

5600 Fishers Lane, Rockville, MD 20857, Phone: 301 443-2619, E-mail: 

[email protected].

    RIN: 0930-AA10



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Disease Control and Prevention (CDC)



Final Rule Stage



142. Control of Communicable Diseases: Foreign and Possessions



    Legal Authority: 42 U.S.C. 243; 42 U.S.C. 264 and 265; 42 U.S.C. 

267 and 268; 42 U.S.C. 270 and 271

    Abstract: By statute, the Secretary of Health and Human Services 

has broad authority to prevent introduction, transmission, and spread 

of communicable diseases from foreign countries into the United States 

and from one State or possession into another. Communicable disease 

regulations are divided into two parts: Part 71 pertaining to foreign 

arrivals and part 70 pertaining to interstate matters. This rule (42 

CFR Part 71) will update and improve CDC's response to both global and 

domestic disease threats by creating a multi-tiered illness detection 

and response process thus substantially enhancing the public health 

system's ability to slow the introduction, transmission, and spread of 

communicable disease. The final rule focuses primarily on requirements 

relating to the reporting of deaths and illnesses onboard aircrafts and 

ships, and the collection of specific traveler contact information for 

the purpose of CDC contacting travelers in the event of an exposure to 

a communicable disease.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   11/30/05  70 FR 71892

NPRM Comment Period End.............   01/20/06  .......................

Final Action........................   09/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Stacy Howard, Health Scientist, Department of 

Health and Human Services, Centers for Disease Control and Prevention, 

MS E-03, 1600 Clifton Road, NE., Atlanta, GA 30329, Phone: 404 498-

1600, E-mail: [email protected].

    RIN: 0920-AA12



143. Control of Communicable Diseases: Interstate



    Legal Authority: 28 U.S.C. 198; 28 U.S.C. 231; 25 U.S.C. 1661; 42 

U.S.C. 243; 42 U.S.C. 248 and 249; 42 U.S.C. 264; 42 U.S.C. 266 to 268; 

42 U.S.C. 270 to 272; 42 U.S.C. 2001

    Abstract: By statute, the Secretary of Health and Human Services 

has broad authority to prevent introduction, transmission, and spread 

of communicable diseases from foreign countries into the United States 

and from one State or possession into another. Communicable disease 

regulations are divided into two parts: Part 71 pertaining to foreign 

arrivals and part 70 pertaining to interstate matters. This rule (42 

CFR Part 70) will update and improve CDC's response to both global and 

domestic disease threats by creating a multi-tiered illness detection 

and response process thus substantially enhancing the public health 

system's ability to slow the introduction, transmission, and spread of 

communicable disease. The proposed final rule focuses primarily on 

requirements relating to the reporting of deaths and illnesses onboard 

aircrafts, and the collection of specific traveler contact information 

for the purpose of CDC contacting travelers in the event of an exposure 

to a communicable disease.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   11/30/05  70 FR 71892

NPRM Comment Period End.............   01/30/06  .......................

Final Action........................   09/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Stacy Howard, Health Scientist, Department of 

Health and Human Services, Centers for Disease Control and Prevention, 

MS E-03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 404 498-1600, 

E-mail: [email protected].

    RIN: 0920-AA22



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Disease Control and Prevention (CDC)



Completed Actions



144. Quality Assurance Requirements for Respirators



    Legal Authority: 29 U.S.C. 651 et seq.; 30 U.S.C. 3; 30 U.S.C. 5; 

30 U.S.C. 7; 30 U.S.C. 811; 30 U.S.C. 842(h); 30 U.S.C. 844

    Abstract: NIOSH plans to modify the Administrative/Quality 

Assurance sections of 42 CFR part 84, Approval of Respiratory 

Protective Devices. Areas for potential modification in this module 

are: (1) Upgrade of quality assurance requirements; (2) ability to use 

private sector quality auditors and private sector testing laboratories 

in the approval program; and (3) revised approval label requirements.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   12/10/08  73 FR 75045

NPRM Comment Period End.............   02/09/09  .......................

NPRM Comment Period Reopened........   03/04/09  74 FR 9381

NPRM Comment Period Reopened End....   04/10/09  .......................

NPRM Comment Period Reopening          05/21/09  74 FR 23815

 Extended.

NPRM Comment Period End.............   10/09/09  .......................

Withdrawn...........................   05/01/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.



[[Page 40057]]



    Agency Contact: William E. Newcomb, Physical Scientist, Department 

of Health and Human Services, Centers for Disease Control and 

Prevention, PO Box 18070, 626 Cochran Mill Road, Pittsburgh, PA 15236, 

Phone: 412 386-5200, E-mail: [email protected].

    RIN: 0920-AA04



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Food and Drug Administration (FDA)



Prerule Stage



145. 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; 21 

U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 

21 U.S.C. 381

    Abstract: Pursuant to section 610 of the Regulatory Flexibility 

Act, FDA is currently undertaking a review of regulations promulgated 

under the Prescription Drug Marketing Act (PDMA) including those 

contained in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 

64 FR 67762 and 67763). The purpose of this review is to determine 

whether the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 

(as amended in 64 FR 67762 and 67763) should be continued without 

change, or whether they should be amended or rescinded, consistent with 

the stated objectives of applicable statues, to minimize adverse 

impacts on a substantial number of small entities. FDA solicited 

comments on the following: (1) The continued need for the regulations 

in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 

67762 and 67763); (2) the nature of complaints or comments received 

from the public concerning the regulations in 21 CFR part 203 and 21 

CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the 

complexity of the regulations in 21 CFR part 203 and 21 CFR 205.3 and 

205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which 

the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as 

amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with 

other Federal rules, and to the extent feasible, with State and local 

governmental rules; and (5) the degree to which technology, economic 

conditions, or other factors have changed in the area affected by the 

regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended 

in 64 FR 67762 and 67763).

    FDA received one comment on this review; and FDA notes that 

portions of the PDMA have been stayed in connection with RxUSA 

Wholesale, Inc., v. HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006), aff'd, 

2008 U.S. App. LEXIS 14661 (2d Cir. 2008); and that the litigation 

itself has been administratively closed (with either party having the 

right to reopen) through June 30, 2011. FDA is certifying that it is 

not feasible for the agency to complete its review by December 4, 2010, 

and therefore is extending the completion date by one year.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Begin Review of Current Regulation..   11/24/08  .......................

End Review of Current Regulation....   12/00/11  .......................

------------------------------------------------------------------------



    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, E-mail: pdma610(c)[email protected].

    RIN: 0910-AG14



146.  Requirements for Testing Human Blood Donors for Evidence 

of Infection Due to Communicable Disease Agents (Section 610 Review)



    Legal Authority: 21 U.S.C. 321; 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. 360c and 360d; 21 U.S.C. 

360h and 360i; 21 U.S.C. 371 and 372; 21 U.S.C. 374; 21 U.S.C. 381; 42 

U.S.C. 216; 42 U.S.C. 262 to 264; 42 U.S.C. 263; 42 U.S.C. 263a; 42 

U.S.C. 264

    Abstract: FDA is undertaking a review of 21 CFR 610.40, 610.41, 

610.42, 610.44, 640.67, 640.70, (as amended in 66 FR 31146) under 

section 610 of the Regulatory Flexibility Act. The purpose of this 

review is to determine whether the regulations in 21 CFR 610.40, 

610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) 

should be continued without change, or whether they should be amended 

or rescinded, consistent with the stated objectives of applicable 

statutes, to minimize adverse impacts on a substantial number of small 

entities. FDA will consider, and is soliciting comments on, the 

following: (1) The continued need for the rule; (2) the nature of 

complaints or comments received concerning the rule from the public; 

(3) the complexity of the rule; (4) the extent to which the rule 

overlaps, duplicates, or conflicts with other Federal rules, and, to 

the extent feasible, with State and local governmental rules; and (5) 

the length of time since the rule has been evaluated or the degree to 

which technology, economic conditions, or other factors have changed in 

the area affected by the rule.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Begin Review of Current Regulation..   06/00/11  .......................

End Review of Current Regulation....   12/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Melissa Reisman, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, Center for 

Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville 

Pike, Rockville, MD 20852, Phone: 301 827-6210.

    RIN: 0910-AG61



147.  General Requirements for Blood, Blood Components, and 

Blood Derivatives; Donor Notification (Section 610 Review)



    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 and 

352; 21 U.S.C. 355; 21 U.S.C. 360 and 360j; 21 U.S.C. 371; 21 U.S.C. 

374; 42 U.S.C. 216; 42 U.S.C. 262; 42 U.S.C. 263a; 42 U.S.C. 264; et 

seq.

    Abstract: FDA is undertaking a review of 21 CFR 606.100(b), 

606.160(b) and 630.6 (as amended in 66 FR 31165) under section 610 of 

the Regulatory Flexibility Act. The purpose of this review is to 

determine whether the regulations in 21 CFR 606.100(b), 606.160(b) and 

630.6 (as amended in 66 FR 31165) should be continued without change, 

or whether they should be amended or rescinded, consistent with the 

stated objectives of applicable statutes, to minimize adverse impacts 

on a substantial number of small entities. FDA will consider, and is 

soliciting comments on, the following: (1) The continued need for the 

rule; (2) the nature of complaints or comments received concerning the 

rule from the public; (3) the complexity of the rule; (4) the extent to 

which the rule overlaps, duplicates, or conflicts with other Federal 

rules, and, to the extent feasible, with State and local governmental 

rules;



[[Page 40058]]



and (5) the length of time since the rule has been evaluated or the 

degree to which technology, economic conditions, or other factors have 

changed in the area affected by the rule.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Begin Review........................   06/00/11  .......................

End Review..........................   12/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: No.

    Agency Contact: Melissa Reisman, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, Center for 

Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville 

Pike, Rockville, MD 20852, Phone: 301 827-6210.

    RIN: 0910-AG62



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Food and Drug Administration (FDA)



Proposed Rule Stage



148. 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

------------------------------------------------------------------------

NPRM................................   03/00/12  .......................

------------------------------------------------------------------------



    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, E-mail: [email protected].

    RIN: 0910-AC52



149. 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 products labeled to relieve upset stomach associated 

with overindulgence in food and drink and to relieve symptoms 

associated with a hangover. The second action addresses acetaminophen 

safety. The third action addresses products marketed for children under 

2 years old and weight- and age-based dosing for children's products. 

The fourth action addresses combination products containing the 

analgesic acetaminophen or aspirin and sodium bicarbonate used as an 

antacid ingredient. The last document finalizes the internal analgesic 

products monograph.

    Timetable:



------------------------------------------------------------------------

               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 (Acetaminophen)................   04/00/12  .......................

                                     -----------------------------------

NPRM (Amendment) (Pediatric)........           To Be Determined

NPRM (Amendment) (Sodium                       To Be Determined

 Bicarbonate).

NPRM (Overindulgence/Hangover)......           To Be Determined

Final Action (Internal Analgesics)..           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF36



150. Over-the-Counter (OTC) Drug Review--Oral Health Care 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 to 360a; 21 U.S.C. 371 to 371a

    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 NPRM and 

final action will address oral health care products used to reduce or 

prevent dental plaque and gingivitis.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

ANPRM (Plaque Gingivitis)...........   05/29/03  68 FR 32232

ANPRM Comment Period End............   08/27/03

NPRM (Benzocaine)...................   12/00/11

                                     -----------------------------------

NPRM (Plaque Gingivitis)............           To Be Determined

Final Action........................           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, 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, E-mail: [email protected].

    RIN: 0910-AF40



151. 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 

action finalizes



[[Page 40059]]



sunscreen labeling and testing requirements for both ultraviolet B and 

ultraviolet A radiation protection. The second action addresses other 

safety and effectiveness issues for OTC sunscreen drug products. The 

third action addresses active ingredients reviewed under Time and 

Extent Applications. The fourth action addresses the safety of 

sunscreen products. The last action addresses combination products 

containing sunscreen and insect repellent ingredients.

    Timetable:



------------------------------------------------------------------------

               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)..............   08/00/11

NPRM (Safety and Effectiveness).....   08/00/11

NPRM (Time and Extent Applications).   04/00/12

ANPRM (Safety)......................   06/00/12

                                     -----------------------------------

NPRM (Sunscreen and Insect                     To Be Determined

 Repellent).

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, 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, E-mail: [email protected].

    RIN: 0910-AF43



152. Over-the-Counter (OTC) Drug Review--Weight Control 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 NPRM 

addresses the use of benzocaine for weight control. The first final 

action finalizes the 2005 proposed rule for weight control products 

containing phenylpropanolamine. The second final action will finalize 

the proposed rule for weight control products containing benzocaine.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM (Phenylpropanolamine)..........   12/22/05  70 FR 75988

NPRM Comment Period End.............   03/22/06

NPRM (Benzocaine)...................   03/09/11  76 FR 12916

NPRM Comment Period End.............   06/07/11

                                     -----------------------------------

Final Action (Phenylpropanolamine)..           To Be Determined

Final Action (Benzocaine)...........           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, 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, E-mail: [email protected].

    RIN: 0910-AF45



153. 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 products. The second action addresses testing 

requirements.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM (Healthcare)...................   06/17/94  59 FR 31402

Comment Period End..................   12/15/95

NPRM (Consumer).....................   01/00/12

                                     -----------------------------------

NPRM (Food Handlers)................           To Be Determined

NPRM (Testing)......................           To Be Determined

Final Action (Consumer).............           To Be Determined

Final Action (Testing)..............           To Be Determined

Final Action (Food Handlers)........           To Be Determined

Final Action (First Aid Antiseptic).           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, 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, E-mail: [email protected].

    RIN: 0910-AF69



154. Import Tolerances for Residues of Unapproved New Animal Drugs in 

Food



    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 360b(a)(6); 21 U.S.C. 371

    Abstract: The Food and Drug Administration (FDA) plans to publish a 

proposed rule related to the implementation of the import tolerances 

provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA 

authorizes FDA to establish tolerances for unapproved new animal drugs 

where edible portions of animals imported into the United States may 

contain residues of such drugs (import tolerances). It is unlawful to 

import animal-derived food that bears or contains residues of a new 

animal drug that is not approved in the United States, unless FDA has 

established an import tolerance for that new animal drug and the 

residue of the new animal drug in the animal-derived food does not 

exceed that tolerance.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   09/00/11

NPRM Comment Period End.............   12/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Thomas Moskal, Consumer Safety Officer, Department 

of Health and Human Services, Food and Drug Administration, Center for 

Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place, 

Rockville, MD 20855, Phone: 240 276-9242, Fax: 240 276-9241, E-mail: 

[email protected].

    RIN: 0910-AF78



[[Page 40060]]



155. 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. The proposal would adopt portions of an IEC 

standard to achieve greater harmonization and reflect current science. 

In addition, the proposal would include an alternative mechanism for 

providing certification and identification, address novelty laser 

products, and clarify the military exemption for laser products.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   11/00/11

------------------------------------------------------------------------



    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, E-mail: [email protected].

    RIN: 0910-AF87



156. Pet Food Labeling Requirements



    Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 

1002(a)(3)

    Abstract: The President signed into law the Food and Drug 

Administration Amendments Act of 2007 (FDAAA) on September 27, 2007 

(Pub. L. 110-85). Title X of the FDAAA includes several provisions 

pertaining to food safety, including the safety of pet food. Section 

1002(a)(3) of the new law directs FDA to issue new regulations to 

establish updated standards for the labeling of pet food that include 

nutritional and ingredient information. This same provision of the law 

also directs that, in developing these new regulations, FDA consult 

with the Association of American Feed Control Officials and other 

relevant stakeholder groups, including veterinary medical associations, 

animal health organizations, and pet food manufacturers.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   03/00/12

NPRM Comment Period End.............   06/00/12

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: William Burkholder, Veterinary Medical Officer, 

Department of Health and Human Services, Food and Drug Administration, 

Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 

Standish Place, Rockville, MD 20855, Phone: 240 453-6865, E-mail: 

[email protected].

    RIN: 0910-AG09



157. Current Good Manufacturing Practice in Manufacturing, Processing, 

Packing or Holding Animal Food



    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350e; 21 U.S.C. 371; 21 

U.S.C. 374; 42 U.S.C. 264; Pub. L. 110-85, sec 1002(a)(2); Pub. L. 111-

353

    Abstract: The Food and Drug Administration (FDA) is proposing 

regulations for preventive controls for animal feed ingredients and 

mixed animal feed to provide greater assurance that marketed animal 

feed ingredients and mixed feeds intended for all animals, including 

pets, are safe. This action is being taken as part of the FDA's Animal 

Feed Safety System initiative. This action is also being taken to carry 

out the requirements of the Food and Drug Administration Amendments Act 

of 2007, under section 1002(a), and the Food Safety Modernization Act 

of 2010, under section 103.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   09/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Kim Young, Deputy Director, Division of Compliance, 

Department of Health and Human Services, Food and Drug Administration, 

Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 

Standish Place, Rockville, MD 20855, Phone: 240 276-9207, E-mail: 

[email protected].

    RIN: 0910-AG10



158. 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................................   12/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AG12



159. Electronic Distribution of Content of Labeling for Human 

Prescription Drug and 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, 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................................   10/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Lisa Dwyer, Senior Advisor for Pharmacy Affairs, 

Department of Health and Human Services, Food and Drug Administration, 

Office of Policy, WO 32, Room 4253, 10903 New Hampshire Avenue, Silver 

Spring, MD 20993,



[[Page 40061]]



Phone: 301 796-4709, E-mail: [email protected].

    RIN: 0910-AG18



160. Unique Device Identification



    Legal Authority: Not Yet Determined

    Abstract: The Food and Drug Administration Amendments Act of 2007 

(FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding 

section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to 

promulgate regulations establishing a unique identification system for 

medical devices requiring the label of medical devices to bear a unique 

identifier, unless FDA specifies an alternative placement or provides 

for exceptions. The unique identifier must adequately identify the 

device through distribution and use, and may include information on the 

lot or serial number.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   09/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: John J. Crowley, Senior Advisor for Patient Safety, 

Department of Health and Human Services, Food and Drug Administration, 

Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New 

Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980-1936, E-mail: 

[email protected].

    RIN: 0910-AG31



161. Produce Safety Regulation



    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. 

L. 111-353 (signed on January 4, 2011)

    Abstract: The Food Safety Modernization Act requires the Secretary 

to establish and publish science-based minimum standards for the safe 

production and harvesting of those types of fruits and vegetables, 

including specific mixes or categories of fruits and vegetables, that 

are raw agricultural commodities for which the Secretary has determined 

that such standards minimize the risk of serious adverse health 

consequences or death. FDA is proposing to promulgate regulations 

setting enforceable standards for fresh produce safety at the farm and 

packing house. The purpose of the proposed rule is to reduce the risk 

of illness associated with contaminated fresh produce. The proposed 

rule will be based on prevention-oriented public health principles and 

incorporate what we have learned in the past decade since the agency 

issued general good agricultural practice guidelines entitled ``Guide 

to Minimize Microbial Food Safety Hazards for Fresh Fruits and 

Vegetables'' (GAPs Guide). The proposed rule also will reflect comments 

received on the agency's 1998 update of its GAPs guide and its July 

2009 draft commodity specific guidances for tomatoes, leafy greens, and 

melons. Although the proposed rule will be based on recommendations 

that are included in the GAPs guide, FDA does not intend to make the 

entire guidance mandatory. FDA's proposed rule would, however, set out 

clear standards for implementation of modern preventive controls. The 

proposed rule also would emphasize the importance of environmental 

assessments to identify hazards and possible pathways of contamination 

and provide examples of risk reduction practices recognizing that 

operators must tailor their preventive controls to particular hazards 

and conditions affecting their operations. The requirements of the 

proposed rule would be scale appropriate and commensurate with the 

relative risks and complexity of individual operations. FDA intends to 

issue guidance to assist industry in complying with the requirements of 

the new regulation.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   01/00/12

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, 

Department of Health and Human Services, Food and Drug Administration, 

Center for Food Safety and Applied Nutrition, Office of Food Safety, 

5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436-1636, 

E-mail: [email protected].

    RIN: 0910-AG35



162. Hazard Analysis and Risk-Based Preventive Controls



    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. 

L. 111-353, (signed on January 4, 2011)

    Abstract: The Food and Drug Administration (FDA) Food Safety 

Modernization Act (the FSMA) requires the Secretary of Health and Human 

Services to promulgate regulations to establish science-based minimum 

standards for conducting a hazard analysis, documenting hazards, 

implementing preventive controls, and documenting the implementation of 

the preventive controls; and to define the terms `small business' and 

`very small business.' The FSMA also requires the Secretary to 

promulgate regulations with respect to activities that constitute on-

farm packing or holding of food that is not grown, raised, or consumed 

on a farm or another farm under the same ownership and activities that 

constitute on farm manufacturing or processing of food that is not 

grown, raised, or consumed on a farm or another farm under the same 

ownership.

    FDA is proposing to amend its current good manufacturing practice 

(CGMP) regulations (21 CFR Part 110) for manufacturing, packing, or 

holding human food to require food facilities to develop and implement 

a written food safety plan. This proposed rule would require a food 

facility to have and implement preventive controls to significantly 

minimize or prevent the occurrence of hazards that could affect food 

manufactured, processed, packed, or held by the facility and to provide 

assurances that such food will not be adulterated under section 402 or 

misbranded under section 403(w).

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   10/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: John F. Sheehan, Director, Office of Food Safety, 

Division of Plant and Dairy Food Safety, Department of Health and Human 

Services, Food and Drug Administration, Center for Food Safety and 

Applied Nutrition (HFS-315), Office of Food Safety, 5100 Paint Branch 

Parkway, College Park, MD 20740, Phone: 301 436-1488, Fax: 301 436-

2632, E-mail: [email protected].

    RIN: 0910-AG36



163. ``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 FDA authority to regulate cigarettes, 

cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. 

Section 901 of 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



[[Page 40062]]



products to be subject to the FD&C Act. This proposed rule would deem 

products meeting the statutory definition of ``tobacco product'' found 

at section 201(rr) of the FD&C Act to be subject to FDA's jurisdiction. 

The scope of the proposed rule deeming cigars to be subject to FDA's 

jurisdiction that was previously included in the Unified Agenda is 

being broadened to encompass products that meet the statutory 

definition of ``tobacco product.''

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   10/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: May Nelson, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, 9200 Corporate 

Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, 

E-mail: [email protected].

    RIN: 0910-AG38



164. 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: Since 2003, FDA has seen a dramatic increase in the 

number of device recalls, as well as an increase in the number of death 

and serious injury reports submitted regarding infusion pumps. An 

analysis of the reports reveals that a majority of the recalls and 

failures were caused by user error and/or device design flaw. As a 

result of these incidents, FDA is proposing to issue a draft special 

controls guidance document that, when final, will be a special control 

for infusion pumps. The agency believes that establishing these special 

controls for infusion pumps is necessary to provide reasonable 

assurance of the safety and effectiveness of these devices.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   09/00/11  .......................

NPRM Comment Period End.............   12/00/11  .......................

------------------------------------------------------------------------



    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, E-mail: [email protected].

    RIN: 0910-AG54



165. Food Labeling: Nutrition Labeling for Food Sold in Vending 

Machines



    Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371

    Abstract: The Food and Drug Administration (FDA) is proposing 

regulations to establish requirements for nutrition labeling of certain 

food sold in certain vending machines. FDA is also proposing the terms 

and conditions for vending machine operators registering to voluntarily 

be subject to the requirements of section 4205. FDA is taking this 

action to carry out section 4205 of the Patient Protection and 

Affordable Care Act (``Affordable Care Act'' or ``ACA''), which was 

signed into law on March 23, 2010.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   04/06/11  76 FR 19238

NPRM Comment Period End.............   07/05/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Geraldine A. June, Supervisor, Product Evaluation 

and Labeling Team, Department of Health and Human Services, Food and 

Drug Administration, Center for Food Safety and Applied Nutrition, 

(HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 

301 436-1802, Fax: 301 436-2636, E-mail: [email protected].

    RIN: 0910-AG56



166. Food Labeling: Nutrition Labeling of Standard Menu Items in 

Restaurants and Similar Retail Food Establishments



    Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371

    Abstract: The Food and Drug Administration (FDA) is proposing 

regulations to establish requirements for nutrition labeling of 

standard menu items in chain restaurants and similar retail food 

establishments. FDA is also proposing the terms and conditions for 

restaurants and similar retail food establishments registering to 

voluntarily be subject to the requirements of section 4205. FDA is 

taking this action to carry out section 4205 of the Patient Protection 

and Affordable Care Act (``Affordable Care Act'' or ``ACA''), which was 

signed into law on March 23, 2010.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   04/06/11  76 FR 19192

NPRM Comment Period End.............   06/06/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Geraldine A. June, Supervisor, Product Evaluation 

and Labeling Team, Department of Health and Human Services, Food and 

Drug Administration, Center for Food Safety and Applied Nutrition, 

(HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 

301 436-1802, Fax: 301 436-2636, E-mail: [email protected].

    RIN: 0910-AG57



167.  Requirements for the Testing and Reporting of Tobacco 

Product Constituents, Ingredients, and Additives



    Legal Authority: Pub. L. 111-31, The Family Smoking Prevention and 

Tobacco Control Act, sec 101(b)

    Abstract: Section 915 of the Federal Food, Drug, and Cosmetic Act, 

as amended by the Family Smoking Prevention and Tobacco Control Act, 

requires FDA 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................................   01/00/12  .......................

NPRM Comment Period End.............   04/00/12  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Carol Drew, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, Rm 240 H, 9200 

Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 

276-3904, E-mail: [email protected].

    RIN: 0910-AG59



168.  Further Amendments to General Regulations of the Food and 

Drug Administration To Incorporate Tobacco Products



    Legal Authority: Not Yet Determined

    Abstract: The Food and Drug Administration is seeking to amend 

certain of its general regulations to include tobacco products, where 

appropriate, in light of FDA's authority to regulate these products 

under the Family Smoking Prevention and



[[Page 40063]]



Tobacco Control Act. The proposed rule would cover revisions to the 

document reporting requirements and definition of ``product.''

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   04/14/11  76 FR 20901

NPRM Comment Period End.............   06/13/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Gerie Voss, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, 9200 Corporate 

Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193, 

E-mail: [email protected].

    RIN: 0910-AG60



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Food and Drug Administration (FDA)



Final Rule Stage



169. 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. 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 Action........................   11/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Benson Silverman, 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: 301 436-1459, E-mail: [email protected].

    RIN: 0910-AF27



170. Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) 

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. This action 

addresses labeling for single ingredient bronchodilator products.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM (Amendment--Ephedrine Single      07/13/05  70 FR 40237

 Ingredient).

NPRM Comment Period End.............   11/10/05  .......................

Final Action (Technical Amendment)..   11/30/07  72 FR 67639

Final Action (Amendment--Single        06/00/11  .......................

 Ingredient Labeling).

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF32



171. 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 

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........................   03/00/12  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF33



172. Use of Materials Derived From Cattle in Human Food and Cosmetics



    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 361; 21 U.S.C. 371

    Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), 

effective immediately, to prohibit the use of certain cattle material 

and to address the potential risk of bovine spongiform encephalopathy 

(BSE) in human food, including dietary supplements, and cosmetics. 

Prohibited cattle materials under the IFR include specified risk 

materials, small intestine of all cattle, material from nonambulatory 

disabled cattle, material from cattle not inspected and passed for 

human consumption, and mechanically separated (MS) beef. Specified risk 

materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, 

vertebral column (excluding the vertebrae of the tail, the transverse 

processes of the thoracic and lumbar vertebrae, and the wings of the 

sacrum), and dorsal root ganglia of cattle 30 months and older; and the 

tonsils and distal ileum of the small intestine of all cattle. 

Prohibited cattle materials do not include tallow that contains no more 

than 0.15 percent



[[Page 40064]]



hexane-insoluble impurities and tallow derivatives. This action 

minimizes human exposure to materials that scientific studies have 

demonstrated are highly likely to contain the BSE agent in cattle 

infected with the disease. Scientists believe that the human disease 

variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the 

consumption of products contaminated with the agent that causes BSE.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Interim Final Rule..................   07/14/04  69 FR 42256

Interim Final Rule Effective........   07/14/04  .......................

Interim Final Rule Comment Period      10/12/04  .......................

 End.

Interim Final Rule (Amendments).....   09/07/05  70 FR 53063

Interim Final Rule (Amendments)        10/07/05  .......................

 Effective.

Interim Final Rule (Amendments)        11/07/05  .......................

 Comment Period End.

Interim Final Rule (Amendments).....   04/17/08  73 FR 20785

Interim Final Rule (Amendments)        07/16/08  .......................

 Comment Period End.

Interim Final Rule (Amendments)        07/16/08  .......................

 Effective.

Final Action........................   09/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Amber McCoig, Consumer Safety Officer, Department 

of Health and Human Services, Food and Drug Administration, Center for 

Food Safety and Applied Nutrition, (HFS-316), 5100 Paint Branch 

Parkway, College Park, MD 20740, Phone: 301 436-2131, Fax: 301 436-

2644, E-mail: [email protected].

    RIN: 0910-AF47



173. Label Requirement for Food That Has Been Refused Admission Into 

the United States



    Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 

342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C. 

216; 42 U.S.C. 264

    Abstract: The final rule will require owners or consignees to label 

imported food that is refused entry into the United States. The label 

will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the 

label's characteristics (such as its size) and processes for verifying 

that the label has been affixed properly. We are taking this action to 

prevent the introduction of unsafe food into the United States, to 

facilitate the examination of imported food, and to implement section 

308 of the Public Health Security and Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   09/18/08  73 FR 54106

NPRM Comment Period End.............   12/02/08  .......................

Final Action........................   07/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, Center for 

Food Safety and Applied Nutrition, WO Building 1, Room 4245, 10903 New 

Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-4706, E-mail: 

[email protected].

    RIN: 0910-AF61



174. Cigarette Warning Label Statements



    Legal Authority: Pub. L. 111-31, The Family Smoking Prevention and 

Tobacco Control Act, sec 201

    Abstract: Section 4 of the FCLAA, as amended by section 201 of the 

Tobacco Control Act, requires FDA to issue regulations that require 

color graphics depicting the negative health consequences of smoking to 

accompany required warning statements on cigarette packages and 

advertisements. FDA also may adjust the type size, text and format of 

the required label statements on product packaging and advertising if 

FDA determines that it is appropriate so that both the graphics and the 

accompanying label statements are clear, conspicuous, legible and 

appear within the specified area.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   11/12/10  75 FR 69524

NPRM Comment Period End.............   01/11/11  .......................

Final Action........................   06/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Gerie Voss, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, 9200 Corporate 

Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193, 

E-mail: [email protected].

    RIN: 0910-AG41



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Food and Drug Administration (FDA)



Long-Term Actions



175. Postmarketing Safety Reporting Requirements for Human Drug and 

Biological Products



    Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42 

U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C. 

300aa; 21 U.S.C. 321; 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. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C. 

371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381

    Abstract: The final rule would amend the postmarketing expedited 

and periodic safety reporting regulations for human drugs and 

biological products to revise certain definitions and reporting formats 

as recommended by the International Conference on Harmonisation and to 

define new terms; to add to or revise current reporting requirements; 

to revise certain reporting time frames; and to propose other revisions 

to these regulations to enhance the quality of safety reports received 

by FDA. These revisions were proposed as part of a single rulemaking 

(68 FR 12406) to clarify and revise both premarketing and postmarketing 

safety reporting requirements for human drug and biological products. 

FDA plans to finalize the premarket and postmarket safety reporting 

requirements in separate final rules. Premarketing safety reporting 

requirements were finalized in a separate final rule published on 

September 29, 2010 (75 FR 59961). This final rule applies to 

postmarketing safety reporting requirements.

    Timetable:



------------------------------------------------------------------------

              Action                   Date             FR Cite

------------------------------------------------------------------------

NPRM..............................   03/14/03  68 FR 12406

NPRM Comment Period Extended......   06/18/03  .........................

NPRM Comment Period End...........   07/14/03  .........................

NPRM Comment Period Extension End.   10/14/03

                                   -------------------------------------

Final Action......................            To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, Center for 

Drug Evaluation and Research, WO 51, Room



[[Page 40065]]



6362, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 

301 796-3469, Fax: 301 847-8440, E-mail: [email protected].

    RIN: 0910-AA97



176. Current Good Manufacturing Practice in Manufacturing, Packing, 

Labeling, or Holding Operations for Dietary Supplements



    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 343; 21 

U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264

    Abstract: The Food and Drug Administration published a final rule 

in the Federal Register of June 25, 2007 (72 FR 34752), on current good 

manufacturing practice (CGMP) regulations for dietary supplements. FDA 

also published an Interim Final Rule in the same Federal Register (72 

FR 34959) that provided a procedure for requesting an exemption from 

the final rule requirement that the manufacturer conduct at least one 

appropriate test or examination to verify the identity of any component 

that is a dietary ingredient. This IFR allows for submission to, and 

review by, FDA of an alternative to the required 100 percent identity 

testing of components that are dietary ingredients, provided certain 

conditions are met. This IFR also establishes a requirement for 

retention of records relating to the FDA's response to an exemption 

request.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

ANPRM...............................   02/06/97  62 FR 5700

ANPRM Comment Period End............   06/06/97  .......................

NPRM................................   03/13/03  68 FR 12157

NPRM Comment Period End.............   08/11/03  .......................

Final Rule..........................   06/25/07  72 FR 34752

Interim Final Rule..................   06/25/07  72 FR 34959

Interim Final Rule Comment Period      10/24/07  .......................

 End.

                                     -----------------------------------

Final Action........................           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Linda Kahl, Senior Policy Analyst, Department of 

Health and Human Services, Food and Drug Administration, Center for 

Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, 

College Park, MD 20740, Phone: 301 436-2784, Fax: 301 436-2657, E-mail: 

[email protected].

    RIN: 0910-AB88



177. Medical Gas Containers and Closures; Current Good Manufacturing 

Practice Requirements



    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351 to 21 U.S.C. 353

    Abstract: The Food and Drug Administration is amending its current 

good manufacturing practice regulations and other regulations to 

clarify and strengthen requirements for the label, color, dedication, 

and design of medical gas containers and closures. Despite existing 

regulatory requirements and industry standards for medical gases, there 

have been repeated incidents in which cryogenic containers of harmful 

industrial gases have been connected to medical oxygen supply systems 

in hospitals and nursing homes and subsequently administered to 

patients. These incidents have resulted in death and serious injury. 

There have also been several incidents involving high-pressure medical 

gas cylinders that have resulted in death and injuries to patients. 

These amendments, together with existing regulations, are intended to 

ensure that the types of incidents that have occurred in the past, as 

well as other types of foreseeable and potentially deadly medical gas 

accidents, do not occur in the future. FDA has described a number of 

proposals in the proposed rule including requiring that gas use outlet 

connections on portable cryogenic medical gas containers be securely 

attached to the valve body.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   04/10/06  71 FR 18039

NPRM Comment Period End.............   07/10/06  .......................

                                     -----------------------------------

Final Action........................           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Patrick Raulerson, Regulatory Counsel, Department 

of Health and Human Services, Food and Drug Administration, Center for 

Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3522, Fax: 301 

847-8440, E-mail: [email protected].

    RIN: 0910-AC53



178. Content and Format of Labeling for Human Prescription Drugs and 

Biologics; Requirements for Pregnancy and Lactation Labeling



    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 

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: To amend the regulations governing the format and content 

of labeling for human prescription drugs and biological products (21 

CFR parts 201.56, 201.57, and 201.80). Under FDA's current regulations, 

labeling concerning the use of prescription drugs in pregnancy uses 

letter categories (A, B, C, D, X) to characterize the risk to the fetus 

of using the drug in pregnancy. One of the deficiencies of the category 

system is that drugs may be assigned to the same category when the 

severity, incidence, and types of risk are quite different. 

Dissatisfaction with the category system has been expressed by health 

care providers, medical organizations, experts in the study of birth 

defects, women's health researchers, and women of childbearing age. 

Stakeholders consulted through a public hearing, several focus groups, 

and several advisory committees have recommended that FDA replace the 

category system with a concise narrative summarizing a product's risks 

to pregnant women and to women of childbearing age. Therefore, the 

revised format and the information provided in the labeling would make 

it easier for health care providers to understand the risks and 

benefits of drug use during pregnancy and lactation.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   05/29/08  73 FR 30831

NPRM Comment Period End.............   08/27/08

                                     -----------------------------------

Final Action........................           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department 

of Health and Human Services, Food and Drug Administration, Center for 

Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993-0002, Phone: 301 796-4288, Fax: 301 847-8440, 

E-mail: [email protected].

    RIN: 0910-AF11



179. 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: 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



[[Page 40066]]



(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 antihistamine labeling claims 

for the common cold.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Reopening of Administrative Record..   08/25/00  65 FR 51780

Comment Period End..................   11/24/00  .......................

NPRM (Amendment) (Common Cold)......   08/00/12  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF31



180. Over-the-Counter (OTC) Drug Review--External 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

    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 final 

action addresses the 2003 proposed rule on patches, plasters, and 

poultices. The proposed rule will address issues not addressed in 

previous rulemakings.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Final Action (GRASE dosage forms)...   06/00/12

                                     -----------------------------------

NPRM (Amendment)....................           To Be Determined

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, 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, E-mail: [email protected].

    RIN: 0910-AF35



181. Over-the-Counter (OTC) Drug Review--Laxative 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 to 360a; 21 U.S.C. 371 to 371a

    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 NPRM 

listed will address the professional labeling for sodium phosphate drug 

products. The second NPRM listed will address all other professional 

labeling requirements for laxative drug products. The final action will 

address laxative drug products.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Final Action (Granular Psyllium)....   03/29/07  72 FR 14669

NPRM (Professional Labeling--Sodium    02/11/11  76 FR 7743

 Phosphate).

NPRM Comment Period End.............   03/14/11  .......................

                                     -----------------------------------

NPRM (Professional Labeling)........           To Be Determined

Final Action (Laxative Drug                    To Be Determined

 Products).

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF38



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Food and Drug Administration (FDA)



Completed Actions



182. Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal 

Decongestant) 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. This action 

addresses the ingredient phenylpropanolamine.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM (Amendment) (Sinusitis Claim)..   08/02/04  69 FR 46119

NPRM Comment Period End.............   11/01/04  .......................

NPRM (Phenylephrine Bitartrate).....   11/02/04  69 FR 63482

NPRM Comment Period End.............   01/31/05  .......................

NPRM (Phenylpropanolamine)..........   12/22/05  70 FR 75988

NPRM Comment Period End.............   03/22/06  .......................

Final Action (Amendment) (Sinusitis    10/31/05  70 FR 58974

 Claim).

Final Action (Phenylephrine            08/01/06  71 FR 83358

 Bitartrate).

Withdrawn...........................   03/11/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF34



183. Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for 

OTC Human Use



    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. 358; 21 U.S.C. 360; 21 U.S.C. 371; 21 UCS 

374; 21 U.S.C. 379e

    Abstract: The OTC drug review establishes conditions under which



[[Page 40067]]



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 labeling for convenience (small) size OTC drug packages.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM (Convenience Sizes)............   12/12/06  71 FR 74474

NPRM Comment Period End.............   04/11/07  .......................

Withdrawn...........................   03/11/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF37



184. Over-the-Counter (OTC) Drug Review--Ophthalmic 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. This action 

finalizes the monograph for emergency first aid eyewash drug products.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM (Amendment) (Emergency First      02/19/03  68 FR 7917

 Aid Eyewashes).

NPRM Comment Period End.............   05/20/03  .......................

Withdrawn...........................   03/11/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF39



185. Over-the-Counter (OTC) Drug Review--Skin Protectant 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 identifies safe and effective skin protectant active ingredients 

to treat and prevent diaper rash. The second action addresses skin 

protectant products used to treat fever blisters and cold sores.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Final Action (Technical Amendments).   02/01/08  73 FR 6014

Final Action (Aluminum Acetate)        03/06/09  74 FR 9759

 (Technical Amendment).

Withdrawn...........................   03/11/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, 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, E-mail: [email protected].

    RIN: 0910-AF42



186. Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive 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. 358; 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 proposed 

rule addresses vaginal contraceptive drug products.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Final Action (Warnings).............   12/19/07  72 FR 71769

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF44



187. Over-the-Counter (OTC) Drug Review--Overindulgence In Food and 

Drink 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. This action 

addresses products containing bismuth subsalicylate for relief of 

symptoms of upset stomach due to overindulgence resulting from food and 

drink.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM (Amendment)....................   01/05/05  70 FR 741

NPRM Comment Period End.............   04/05/05

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF51



188. Over-the-Counter (OTC) Drug Review--Antacid 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



[[Page 40068]]



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. One action addresses the labeling 

of products containing sodium bicarbonate as an active ingredient. The 

other action addresses the use of antacids to relieve upset stomach 

associated with overindulgence in food and drink.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF52



189. Over-the-Counter (OTC) Drug Review--Skin Bleaching 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. This action 

addresses skin bleaching drug products containing hydroquinone.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   08/29/06  71 FR 51146

NPRM Comment Period End.............   12/27/06

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, 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, E-mail: [email protected].

    RIN: 0910-AF53



190. Over-the-Counter (OTC) Drug Review--Stimulant 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. This action 

addresses the use of stimulant active ingredients to relieve symptoms 

associated with a hangover.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF56



191. Over-the-Counter (OTC) Drug Review--Antidiarrheal 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. These actions 

address new labeling for antidiarrheal drug products.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF63



192. Over-the-Counter (OTC) Drug Review--Urinary Analgesic 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. This action 

addresses the products used for urinary pain relief.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Mary Chung, 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, E-mail: 

[email protected].

    RIN: 0910-AF70



193. Over-the-Counter (OTC) Drug Review--Certain Category II Active 

Ingredients



    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 Food and Drug Administration (FDA) is proposing that 

certain ingredients in over-the-counter (OTC) drug products are not 

generally recognized as safe and effective or are misbranded. FDA 

issued this proposed rule because we did not receive any data and 

information on these ingredients in response to our request on December 

31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   06/19/08  73 FR 34895

NPRM Comment Period End.............   09/17/08

Withdrawn...........................   03/11/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: David Eng, Department of Health and Human Services, 

Food and Drug Administration, Center for Drug



[[Page 40069]]



Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-9899, E-

mail: [email protected].

    RIN: 0910-AF95



194. Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; 

Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 

Review)



    Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 

331; 21 U.S.C. 342 and 343; 21 U.S.C. 348; 21 U.S.C. 371; 42 U.S.C. 

243; 42 U.S.C. 264; 42 U.S.C. 271

    Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes 

requirements for the labeling of the cartons of shell eggs that have 

not been treated to destroy Salmonella microorganisms. Section 115.50 

(21 CFR 115.50) describes requirements for refrigeration of shell eggs 

held for retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) 

provides that part 16 does not apply to a hearing on an order for 

relabeling, diversion, or destruction of shell eggs under section 361 

of the Public Health Service Act (42 U.S.C. 264) and Sec. Sec.  

101.17(h) and 115.50. FDA amended 21 CFR 101.17(h) on August 20, 2007 

(72 FR 46375) to permit the safe handling statement to appear on the 

inside lid of egg cartons to provide the industry greater flexibility 

in the placement of the statement, provided the words ``keep 

refrigerated'' appear on the principal display panel or information 

panel. FDA is undertaking a review of 21 CFR 101.17(h), 115.50, and 

16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The 

purpose of this review is to determine whether the regulations in 

Sec. Sec.  101.17(h), 115.50 and 16.5(a)(4) should be continued without 

change, or whether they should be amended or rescinded, consistent with 

the stated objectives of applicable statutes, to minimize any 

significant economic impact on a substantial number of small entities. 

FDA will consider, and is soliciting comments on, the following: (1) 

The continued need for the rule; (2) the nature of complaints or 

comments received concerning the rule from the public; (3) the 

complexity of the rule; (4) the extent to which the rule overlaps, 

duplicates, or conflicts with other Federal rules, and, to the extent 

feasible, with State and local governmental rules; and (5) the length 

of time since the rule has been evaluated or the degree to which 

technology, economic conditions, or other factors have changed in the 

area affected by the rule.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Begin Review........................   12/15/09

End Review..........................   12/30/10

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: No.

    Agency Contact: Geraldine A. June, Supervisor, Product Evaluation 

and Labeling Team, Department of Health and Human Services, Food and 

Drug Administration, Center for Food Safety and Applied Nutrition, 

(HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 

301 436-1802, Fax: 301 436-2636, E-mail: [email protected].

    RIN: 0910-AG06



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Medicare & Medicaid Services (CMS)



Prerule Stage



195.  Five Year Review of Work Relative Value Units Under the 

Physician Fee Schedule (CMS-1582-PN)



    Legal Authority: SSA, sec 1848(c)(2)(B)(i)

    Abstract: This proposed notice sets forth proposed revisions to 

work relative value units (RVUs) affecting payment for physicians' 

services. The Act requires that we review RVUs no less than every five 

years. The revised values will be finalized in the CY 2012 Physician 

Fee Schedule final rule and will be effective for services furnished 

beginning January 1, 2012.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Notice..............................   06/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Rebecca Cole, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Mail Stop: C4-03-06, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-1589, E-mail: 

[email protected].

    RIN: 0938-AQ87



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Medicare & Medicaid Services (CMS)



Proposed Rule Stage



196. Home Health Agency (HHA) Conditions of Participation (COPS) (CMS-

3819-P) (Section 610 Review)



    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395x; 42 U.S.C. 

1395cc(a); 42 U.S.C. 1395hh; 42 U.S.C. 1395bb

    Abstract: This proposed rule would revise the existing Conditions 

of Participation (CoPs) that Home Health Agencies (HHAs) must meet to 

participate in the Medicare program. The CoPs were last revised in 

1989. The new requirements will focus on the actual care delivered to 

patients by HHAs, reflect an interdisciplinary view of patient care, 

allow HHAs greater flexibility in meeting quality standards, and 

eliminate unnecessary procedural requirements. These changes are an 

integral part of our efforts to achieve broad-based improvements and 

measurements of the quality of care furnished through federal programs 

while at the same time reducing procedural burdens on providers.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   03/10/97  62 FR 11005

NPRM Comment Period End.............   06/09/97

Second NPRM.........................   09/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Undetermined.

    Agency Contact: Danielle Shearer, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Clinical Standards & Quality, Mail Stop S3-02-01, 

7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, E-

mail: [email protected].

    RIN: 0938-AG81



197. Influenza Vaccination Standard for Certain Medicare Participating 

Providers and Suppliers (CMS-3213-P)



    Legal Authority: Social Security Act secs 1881, 1861, 1102, 1871

    Abstract: This proposed rule would require certain Medicare and 

Medicaid providers and suppliers to offer all patients an annual 

influenza vaccination, unless medically contraindicated or unless the 

patient or patient's representative or surrogate declined vaccination. 

This proposed rule is intended to increase the number of patients 

receiving annual vaccination against seasonal influenza and to



[[Page 40070]]



decrease the morbidity and mortality rate from influenza. This proposed 

rule would also require certain providers and suppliers to develop 

policies and procedures that would allow them to offer vaccinations for 

pandemic influenza in case of a future pandemic influenza event for 

which a vaccine may be developed.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   06/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Lauren Oviatt, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Mail Stop S3-02-01, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-4683, E-mail: 

[email protected].

    RIN: 0938-AP92



198. Hospital Conditions of Participation: Requirements for Hospital 

Inpatient Psychiatric and Rehabilitation Units Excluded From the 

Prospective Payment System and Ltch Requirements (CMS-3177-P)



    Legal Authority: 42 U.S.C. 1385 X; 42 U.S.C. 1396 d; 42 U.S.C. 1395 

hh

    Abstract: This rule proposes requirements for inpatient psychiatric 

units and inpatient rehabilitation facilities under the hospital 

conditions of participation (CoPs). This would allow accrediting 

organizations to deem these units as part of their hospital 

accreditation process providing a timely and cost effective survey and 

certification process under the CoPs. In addition, this rule would 

propose long term care hospital requirements mandated by the Medicare, 

Medicaid and SCHIP Extension Act of 2007.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   09/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Capt. Katherine Berkhousen, Health Insurance 

Specialist, Department of Health and Human Services, Centers for 

Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop S3-02-

01, Baltimore, MD 21244, Phone: 410 786-1154, E-mail: 

[email protected].

    Jeannie Miller, Department of Health and Human Services, Centers 

for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 

MD 21244, Phone: 410 786-3164, E-mail: [email protected].

    RIN: 0938-AP97



199. Proposed Changes to the Hospital Inpatient Prospective Payment 

Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term 

Care Hospital PPS and FY 2012 Rates (CMS-1518-P)



    Legal Authority: sec 1886(d) of the Social Security Act; Pub. L. 

111-148

    Abstract: This annual major proposed rule would revise the Medicare 

hospital inpatient and long-term care hospital prospective payment 

systems for operating and capital-related costs. This proposed rule 

would implement changes arising from our continuing experience with 

these systems.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   06/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: AnKit Patel, Health Insurance Specialist, Division 

of Acute Care, Department of Health and Human Services, Centers for 

Medicare & Medicaid Services, Hospital and Ambulatory Policy Group, 

Mail Stop, C4-25-11, 7500 Security Boulevard, Baltimore, MD 21244, 

Phone: 410 786-4537, E-mail: [email protected].

    RIN: 0938-AQ24



200. Changes to the Hospital Outpatient Prospective Payment System and 

Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-P)



    Legal Authority: Social Security Act, sec 1833; Pub. L. 111-148

    Abstract: This proposed rule would revise the Medicare hospital 

outpatient prospective payment system to implement applicable statutory 

requirements and changes arising from our continuing experience with 

this system. The proposed rule also describes changes to the amounts 

and factors used to determine payment rates for services. In addition, 

the rule proposes changes to the Ambulatory Surgical Center Payment 

System list of services and rates.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   07/00/11

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Paula Smith, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Mail Stop, C5-01-26, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-7809, E-mail: 

[email protected].

    RIN: 0938-AQ26



201. Changes to the ESRD Prospective Payment System For Cy 2012 & 

Quality Incentives Program For CY 2013 (CMS-1577-P)



    Legal Authority: Sec 1881 of the Social Security Act

    Abstract: This major proposed rule would update the bundled payment 

system for End Stage Renal Disease (ESRD) facilities by January 1, 

2012. The rule would also update the Quality Incentives in the ESRD 

Program.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   06/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Janet Samen, Director, Division of Chronic Care 

Management, Department of Health and Human Services, Centers for 

Medicare & Medicaid Services, Mail Stop C5-05-27, 7500 Security 

Boulevard, Baltimore, MD 21244, Phone: 410 786-4533, E-mail: 

[email protected].

    RIN: 0938-AQ27



202.  Medicaid Program Integrity: Registration Of Billing 

Agents, Clearing Houses, Or Other Alternate Payees (CMS-2365-P)



    Legal Authority: 42 U.S.C. 1396a(a)(79) Social Security Act; Pub. 

L. 111-148, sec 6503

    Abstract: This proposed rule would require any agent, 

clearinghouse, or other alternate payee that submits claims on behalf 

of a health care provider to register with the State and the Secretary 

in a form and manner specified by the Secretary.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   10/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Richard Friedman, Director, Division of State 

Systems, Department of Health and Human Services, Centers for Medicare 

& Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-4451, E-mail: 

[email protected].

    RIN: 0938-AQ61



[[Page 40071]]



203.  Medicaid Eligibility Expansion Under the Affordable Care 

Act of 2010 (CMS-2349-P)



    Legal Authority: Pub. L. 111-148, secs 1413, 2001, 2002, 2201

    Abstract: The Affordable Care Act authorizes a major Medicaid 

expansion to individuals who are under 65, not pregnant, not receiving 

Medicare and not eligible for other mandatory eligibility categories. 

This proposed rule would set forth policies for Medicaid expansion 

including household income and household composition, coordination with 

Exchanges, simplifying and streamlining Medicaid eligibility 

determinations.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   06/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Sarah DeLone, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-0615, E-mail: 

[email protected].

    RIN: 0938-AQ62



204.  Payments for Primary Care Services Under the Medicaid 

Program (CMS-2370-P)



    Legal Authority: Pub. L. 111-152, sec 1202

    Abstract: This regulation implements section 1202 of the Health 

Care and Education Reconciliation Act of 2010, which increases Medicaid 

payments for certain primary care services provided in 2013 and 2014. 

The increased payments pertain to services provided by a physician with 

a specialty designation of family medicine, general internal medicine, 

and pediatric medicine. States must pay for these services at a rate 

equal to or greater than the rate paid under Medicare Part B. Rates in 

Medicaid managed care must be consistent with these minimum payment 

rates. The FMAP to states for such services will equal 100% for the 

portion of cost for such primary care services, which is comprised of 

the difference between the Medicare Part B rate and the amount 

applicable in the State Plan as of July 1, 2009.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   10/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Cherly Powell, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-9239, E-mail: 

[email protected].

    RIN: 0938-AQ63



205.  Medicare and Medicaid Electronic Health Record Incentive 

Program--Stage 2 (CMS-0044-P)



    Legal Authority: Pub. L. 111-5 secs 4101, 4102, and 4202

    Abstract: The final rule for the Medicare and Medicaid EHR 

Incentive Programs, which was published in the Federal Register on July 

28, 2010, specifies that CMS will expand on the criteria for meaningful 

use established for Stage 1 to advance the use of certified EHR 

technology by eligible professionals (EPs), eligible hospitals and 

critical access hospitals (CAHs). This proposed rule would establish 

the requirements for Stage 2. As stated in the July 28 final rule, 

``Our goals for the Stage 2 meaningful use criteria, consistent with 

other provisions of Medicare and Medicaid law, expand upon the Stage 1 

criteria to encourage the use of health IT for continuous quality 

improvement at the point of care and the exchange of information in the 

most structured format possible, such as the electronic transmission of 

orders entered using computerized provider order entry (CPOE) and the 

electronic transmission of diagnostic test results.''

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   01/00/12  .......................

------------------------------------------------------------------------



    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, E-mail: [email protected].

    RIN: 0938-AQ84



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Medicare & Medicaid Services (CMS)



Final Rule Stage



206. Enhanced Federal Funding For Medicaid Eligibility Determination 

and Enrollment Activities (CMS-2346-F)



    Legal Authority: Pub. L. 111-148, sec 1413

    Abstract: The Affordable Care Act requires States' residents to 

apply, enroll, receive determinations, and participate in the State 

health subsidy programs known as ``the Exchange''. The Affordable Care 

Act requires many changes to State eligibility and enrollment systems 

and each State is responsible for developing a secure, electronic 

interface allowing the exchange of data. Existing legacy eligibility 

systems are not able to implement the numerous requirements. This rule 

is key to informing States about the higher rates that CMS will provide 

to help them update or build legacy eligibility systems that meet the 

ACA requirements.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   11/08/10  75 FR 68583

NPRM Comment Period End.............   01/07/11  .......................

Final Action........................   06/00/11  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Richard H. Friedman, Director, Division of State 

Systems, Department of Health and Human Services, Centers for Medicare 

& Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-4451, E-mail: 

[email protected].

    RIN: 0938-AQ53



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Medicare & Medicaid Services (CMS)



Long-Term Actions



207. Requirements for Long-Term Care Facilities: Hospice Services (CMS-

3140-F) (Section 610 Review)



    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh

    Abstract: This rule establishes that in order to participate in the 

Medicare and Medicaid programs, long-term care facilities must have an 

agreement with hospice agencies when hospice care is



[[Page 40072]]



provided in a long-term care facility. The rule also contains quality 

of care requirements.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   10/22/10  75 FR 65282

NPRM Comment Period End.............   12/21/10  .......................

Final Action........................   10/00/13  .......................

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Kadie Thomas, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Office of Clinical Standards and Quality, Mail Stop 

S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-

0468, E-mail: [email protected].

    Mary Collins, Health Insurance Specialist, Department of Health and 

Human Services, Centers for Medicare & Medicaid Services, Office of 

Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security 

Boulevard, Baltimore, MD 21244, Phone: 410 786-3189, E-mail: 

[email protected].

    RIN: 0938-AP32



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Medicare & Medicaid Services (CMS)



Completed Actions



208. Amendment to Payment Policies Under the Physician Fee Schedule and 

Part B for CY 2011 (CMS-1503-F2)



    Legal Authority: Social Security Act, sec 1102; Social Security 

Act, sec 1871; Pub. L. 111-148

    Abstract: This amends the ``Medicare Program; Payment Policies 

Under the Physician Fee Schedule and Other Revisions to Part B for CY 

2011'' that appeared in the November 29, 2010, Federal Register.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   07/13/10  75 FR 40040

NPRM Comment Period End.............   09/24/10  .......................

Final Action........................   11/29/10  75 FR 73169

2nd Final Action....................   01/10/11  76 FR 1366

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Carol Bazell, 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: 410 786-6960, E-mail: [email protected] 

gov.

    RIN: 0938-AP79



209. Changes to the Hospital Outpatient Prospective Payment System and 

Ambulatory Surgical Center Payment System For CY 2011 (CMS-1504-FC)



    Legal Authority: sec 1833 of the Social Security Act; BBA, BA, 

BIPA, MMA, Pub. L. 111.148

    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 

changes the Ambulatory Surgical Center Payment System list of services 

and rates.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

NPRM................................   08/03/10  75 FR 46169

NPRM Comment Period End.............   08/31/10  .......................

Final Action........................   11/24/10  75 FR 71800

------------------------------------------------------------------------



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Alberta Dwivedi, Health Insurance Specialist, 

Department of Health and Human Services, Centers for Medicare & 

Medicaid Services, Mail Stop C5-01-26, 7500 Security Boulevard, 

Baltimore, MD 21244, Phone: 410 786-0763, E-mail: 

[email protected].

    RIN: 0938-AP82



210.  Section 508 Hospitals--Medicare and Medicaid Extenders 

Act of 2010 Changes (CMS-1357-N)



    Legal Authority: MMEA, Sec 102

    Abstract: Section 102 of the Medicare and Medicaid Extenders Act of 

2010 extends section 508 of the Medicare Modernization Act of 2003 

(MMA) and certain additional special exception hospital 

reclassifications from October 1, 2010, through September 30, 2011. 

Effective April 1, 2011, section 102 also requires removing section 508 

and special exception hospitals' wage data from the calculation of the 

reclassified wage index if doing so raises the reclassified wage index. 

All hospitals affected by section 102 will be assigned an individual 

special wage index effective April 1, 2011. If the section 508 or 

special exception hospital's wage index applicable for the period 

beginning on October 1, 2010, and ending on March 31, 2011, is lower 

than for the period beginning on April 1, 2011, and ending on September 

30, 2011, the hospital will be paid an additional amount that reflects 

the difference between the wage indices. The provision applies to both 

inpatient and outpatient hospital payments, although the implementation 

timeframe differs for outpatient hospital payments.

    Timetable:



------------------------------------------------------------------------

               Action                    Date            FR Cite

------------------------------------------------------------------------

Notice..............................   04/07/11  76 FR 19365

------------------------------------------------------------------------



    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, E-mail: 

[email protected].

    RIN: 0938-AQ97



[FR Doc. 2011-15487 Filed 7-6-11; 8:45 am]

BILLING CODE 4150-24-P