<DOC>
[December 10, 2007 (Volume 72, Number 236)]
[Unified Agenda]
From the Federal Register Online via GPO Access [frwais.access.gpo.gov]
[DOCID: f:ua071007.wais]

[Page 70044-70064]
 
Department of Health and Human Services

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Part VII

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Semiannual Regulatory Agenda

[[Page 70044]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

_______________________________________________________________________

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 Regulatory Flexibility Act of 1980 and Executive Order 
12866 require issuance of the following inventory of the rulemaking 
actions being developed by the Department. The purpose is to encourage 
public participation in the regulatory process by providing, at as 
early a stage as possible, summarized information about regulatory 
actions under consideration.

FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, 
Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The capsulized information provided presents 
for public scrutiny a forecast of the rulemaking activities that the 
Department expects to undertake over the foreseeable future. We focus 
primarily on those areas of work expected to result in publication of 
Notices of Proposed Rulemaking or Final Rules within the next 12 
months.

     For this edition of the Department of Health and Human 
Services' regulatory agenda, the most important significant 
regulatory actions and a Statement of Regulatory Priorities are 
included in The Regulatory Plan, which appears in both the online 
Unified Agenda and in part II of the Federal Register that includes 
the Unified Agenda.

     In addition, beginning with the fall 2007 edition, the 
Internet will be the basic means for disseminating the Unified 
Agenda. The complete Unified Agenda will be available online at 
www.reginfo.gov, in a format that offers users a greatly enhanced 
ability to obtain information from the Agenda database.

     Because publication in the Federal Register is mandated for 
the regulatory flexibility agendas required by the Regulatory 
Flexibility Act (5 U.S.C. 602), the Department of Health and Human 
Services' printed agenda entries include only:

(1) rules that are in the Agency's regulatory flexibility agenda, in 
accordance with the Regulatory Flexibility Act, because they are likely 
to have a significant economic impact on a substantial number of small 
entities; and

(2) any rules that the Agency has identified for periodic review under 
section 610 of the Regulatory Flexibility Act.

     Printing of these entries is limited to fields that contain 
information required by the Regulatory Flexibility Act's Agenda 
requirements. Additional information on these entries is available 
in the Unified Agenda published on the Internet. In addition, for 
fall editions of the Agenda, the entireRegulatory Plan will 
continue to be printed in the Federal Register, as in past years, 
including the Health and Human Services' Regulatory Plan.

     We welcome the views of all concerned with regard to these 
planned rulemakings. Comments may be directed to the agency 
officials cited in each of the summaries below; if early attention 
at the Secretary's level appears needed, comments should be sent 
to: Ann C. Agnew, Executive Secretary to the Department, Room 603H, 
200 Independence Avenue SW., Washington, DC 20201.

Dated: September 26, 2007.

 Ann C. Agnew,

Executive Secretary to the Department.

                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
311         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical           0930-AA10
            Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------

                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
312         Control of Communicable Diseases, Interstate and Foreign Quarantine (Reg Plan Seq No.     0920-AA12
            37)...................................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
313         Status of Certain Additional Over-the-Counter Drug Category II and III Active             0910-AF75
            Ingredients (Section 610 Review)......................................................
314         Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific    0910-AF76
            Reagents (Section 610 Review).........................................................

[[Page 70045]]

315         Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber-        0910-AF77
            Containing Medical Device (Section 610 Review)........................................
316         Financial Disclosure by Clinical Investigators (Section 610 Review)...................    0910-AF79
317         Beverages: Bottled Water (Section 610 Review).........................................    0910-AF80
318         Food Labeling; Nutrient Content Claims: Definition for ``High Potency'' and Definition    0910-AF83
            of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and
            Conventional Foods (Section 610 Review)...............................................
----------------------------------------------------------------------------------------------------------------

                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
319         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg      0910-AC52
            Plan Seq No. 38)......................................................................
320         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling (Reg Plan Seq No. 39)...............
321         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
322         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
323         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
324         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
325         Label Requirement for Food That Has Been Refused Admission Into the United States (Reg    0910-AF61
            Plan Seq No. 40)......................................................................
326         Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
327         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
328         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
329         Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
330         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 43).............................
331         Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 44)..............    0910-AC14
332         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs.............    0910-AC35
333         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
334         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
335         Charging for Investigational Drugs....................................................    0910-AF13
336         Expanded Access to Investigational Drugs for Treatment Use (Reg Plan Seq No. 46)......    0910-AF14
337         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
338         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
339         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
340         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
341         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
342         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
343         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
344         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
345         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
346         Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
347         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
348         Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

[[Page 70046]]

                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
349         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
350         Health Claims.........................................................................    0910-AF09
351         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
352         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
353         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
354         Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
355         Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and        0910-AF99
            Pectin (Section 610 Review)...........................................................
----------------------------------------------------------------------------------------------------------------

                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
356         Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality           0910-AF71
            Systems Regulations (Completion of a Section 610 Review)..............................
357         Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction     0910-AF73
            Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use
            (Section 610 Review)..................................................................
358         Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for    0910-AF74
            Internal Use: Required Alcohol Warning (Section 610 Review)...........................
----------------------------------------------------------------------------------------------------------------

                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
359         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
360         Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
361         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-P)...............    0938-AO53
362         Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate      0938-AO94
            Updates (CMS-1393-P)..................................................................
363         Establishing Additional Medicare Provider and Supplier Enrollment Safeguards (CMS-6045-   0938-AP01
            P)....................................................................................
364         Hospice Wage Index for FY 2009 (CMS-1548-P)...........................................    0938-AP14
365         Changes to the Hospital Inpatient Prospective Payment Systems and FY 2009 Rates (CMS-     0938-AP15
            1390-P)...............................................................................
366         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP17
            Center Payment System for CY 2009 (CMS-1404-P) (Reg Plan Seq No. 50)..................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
367         End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610          0938-AG82
            Review) (Reg Plan Seq No. 52).........................................................
368         Hospice Care Conditions of Participation (CMS-3844-F) (Section 610 Review) (Reg Plan      0938-AH27
            Seq No. 53)...........................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
369         Hospital Conditions of Participation: Laboratory Services (CMS-3014-F) (Section 610       0938-AJ29
            Review)...............................................................................

[[Page 70047]]

370         Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics,          0938-AO84
            Orthotics, and Supplies (DMEPOS) (CMS-6006-F).........................................
371         Medicaid Graduate Medical Education (CMS-2279-F) (Section 610 Review).................    0938-AO95
----------------------------------------------------------------------------------------------------------------

                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
372         Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships (CMS-1810-F)............................................................
373         Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies (CMS-1270-F)..................................................
374         Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-    0938-AN58
            F)....................................................................................
375         Medicaid Prescription Drugs--Average Manufacturer Price (CMS-2238-FC).................    0938-AO20
376         Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate      0938-AO30
            Updates and Policy Changes (CMS-1529-F)...............................................
377         Home Health Prospective Payment System Refinements and Rate Update for Calendar Year      0938-AO32
            2008 (CMS-1541-F).....................................................................
378         Cost Limits for Governmentally Operated Providers (CMS-2258-FC) (Completion of a          0938-AO57
            Section 610 Review)...................................................................
379         Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2008 (CMS-      0938-AO63
            1551-F)...............................................................................
380         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AO64
            Update for FY 2008 (CMS-1545-F).......................................................
381         Changes to the Hospital Inpatient Prospective Payment Systems and FY 2008 Rates (CMS-     0938-AO70
            1533-FC)..............................................................................
382         Hospice Wage Index for FY 2008 (CMS-1539-F)...........................................    0938-AO72
383         Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs)       0938-AO73
            Effective January 1, 2008 (CMS-1517-F)................................................
384         Fee Schedule for Payment of Ambulance Services--Update for CY 2008 (CMS-1552-N).......    0938-AO85
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________

311. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN 
CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH

Legal Authority: PL 106-310, 42 USC 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                            02/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Paolo Del Vecchio, 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

RIN: 0930-AA10

[[Page 70048]]

_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

312. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE

 Regulatory Plan: This entry is Seq. No. 37 in part II of this issue of 
the Federal Register.

RIN: 0920-AA12
_______________________________________________________________________
Department of Health and Human Services (HHS)             Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

313. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II AND 
III ACTIVE INGREDIENTS (SECTION 610 REVIEW)

Legal Authority: 5 USC 610

Abstract: Section 310.545 (21 CFR part 310.545) codifies a final rule 
that was issued stating certain first aid antiseptic, vaginal 
contraceptive, and antimicrobial diaper rash ingredients in over-the-
counter (OTC) drug products are not generally recognized as safe and 
effective and are misbranded. This rule took into consideration the 
reports and recommendations of various OTC drug advisory review panels 
and public comment on proposed Agency regulations. Based on the absence 
of substantive comments in opposition to the Agency's proposed 
nonmonograph status for various ingredients, as well as the failure of 
interested parties to submit new data or information to FDA, the Agency 
determined that the presence of the subject ingredients in an OTC drug 
product would result in that product not being generally recognized as 
safe and effective and would result in misbranding.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 310.545. The purpose of 
this review is to determine whether the regulation in section 310.545 
should be continued without change, or whether it should be further 
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 regulation in section 
310.545; (2) the nature of the complaints or comments received 
concerning the regulation in section 310.545; (3) the complexity of the 
regulations in section 310.545; (4) the extent to which the regulation 
in section 310.545 overlaps, duplicates, or conflicts with other 
Federal, State, or governmental rules; and (5) the degree to which 
technology, economic conditions, or other factors have changed for the 
products still subject to the regulation in section 310.545.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF75
_______________________________________________________________________

314. MEDICAL DEVICES: CLASSIFICATION/RECLASSIFICATION; RESTRICTED 
DEVICES; ANALYTE SPECIFIC REAGENTS (SECTION 610 REVIEW)

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j

Abstract: FDA is initiating a review under section 610 of the 
Regulatory Flexibility Act for two regulations in part 809. The purpose 
of this review is to determine if 21 CFR part 809.10 and 809.30 should 
be continued without change, or should be amended or rescinded to 
minimize adverse economic impact on small entities. FDA is soliciting 
and will consider comments on the following: 1) The continued need for 
21 CFR part 809.10 and 809.30; 2) the nature of complaints or comments 
received concerning 21 CFR part 809.10 and 809.30; 3) the complexity of 
21 CFR part 809.10 and 809.30; 4) the extent to which 21 CFR part 
809.10 and 809.30 overlap, duplicate, or conflict with other Federal, 
State, or local government rules; and 5) the degree to which 
technology, economic conditions, or other factors have changed in the 
area affected by 21 CFR part 809.10 and 809.30.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/01/07
End Review                      11/00/07

Regulatory Flexibility Analysis Required: No

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: myrna.hanna@fda.hhs.gov

RIN: 0910-AF76

[[Page 70049]]

_______________________________________________________________________

315. AMENDED ECONOMIC IMPACT ANALYSIS OF FINAL RULE ON USER LABELING ON 
NATURAL RUBBER-CONTAINING MEDICAL DEVICE (SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
357; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

Abstract: FDA is initiating a review of the regulations in part 801 
under section 610 of the Regulatory Flexibility Act. The purpose of 
this review is to determine, consistent with stated objectives and 
applicable statutes, whether the regulations in part 801 should be 
continued without change, amended, or rescinded in order 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 regulation; 2) the nature of 
complaints or comments received concerning the regulation; 3) the 
complexity of the regulation; 4) the extent to which a regulation in 
part 801 overlaps, duplicates, or conflicts with other Federal rules, 
and to the extent feasible, with State and local government rules; and 
5) the degree to which technology, economic conditions, or other 
factors have changed in the area affected by the regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/30/97                    62 FR 51021
Final Action Effective          09/30/98
Begin Review of Current 
Regulation                      01/02/07
End Review of Current Regulation12/00/07

Regulatory Flexibility Analysis Required: No

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: myrna.hanna@fda.hhs.gov

RIN: 0910-AF77
_______________________________________________________________________

316. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c to 360j; 21 USC 371; 21 USC 
372; 21 USC 373; 21 USC 374; 21 USC 375; 21 USC 376; 21 USC 379; 42 USC 
262

Abstract: FDA is undertaking a review of 21 CFR part 54, under section 
610 of the Regulatory Flexibility Act. The purpose of this review is to 
determine whether the regulations in part 54 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 
will consider, and is soliciting comments on the following: (1) The 
continued need for the regulations in part 54; (2) the nature of 
complaints or comments received concerning the regulations in part 54; 
(3) the complexity of the regulations in part 54, (4) the extent to 
which the regulations in part 54 overlap, duplicate, or conflict with 
other Federal, State, or governmental rules; and (5) the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the regulations in part 54.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 
Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: howard.mullerjr@fda.hhs.gov

Stephen M. Ripley, Team Leader, 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 
20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Elisa D. Harvey, Director, Office of Device Evaluation, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, Corp Room 130F (HFZ-215), 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 594-1190
Fax: 301 594-3076
Email: elisa.harvey@fda.hhs.gov

RIN: 0910-AF79
_______________________________________________________________________

317. BEVERAGES: BOTTLED WATER (SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21 
USC 348; 21 USC 349; 21 USC 371; 21 USC 379e

Abstract: Section 165.110 (21 CFR part 165.110) describes requirements 
for identity and quality standards for bottled water. FDA is 
undertaking a review of section 165.110 under section 610 of the 
Regulatory Flexibility Act. The purpose of this review is to determine 
whether the regulations in section 165.110 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 regulations in section 165.110; (2) the 
nature of complaints or comments received concerning the regulations in 
section 165.110; (3) the complexity of the regulations; (4) the extent 
to which the regulations in section 165.110 overlap, duplicate, or 
conflict with other Federal rules, and to the extent feasible, with 
State or governmental rules; and (5) the degree to which technology, 
economic conditions, or other factors have changed in the area affected 
by the regulations in section 165.110.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    03/01/07
End Review                      12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: David Zorn, Lead Economist, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition, ORP (HFS-020),

[[Page 70050]]

5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1825
Fax: 301 436-2505
Email: david.zorn@fda.hhs.gov

RIN: 0910-AF80
_______________________________________________________________________

318. FOOD LABELING; NUTRIENT CONTENT CLAIMS: DEFINITION FOR ``HIGH 
POTENCY'' AND DEFINITION OF ``ANTIOXIDANT'' FOR USE IN NUTRIENT CONTENT 
CLAIMS FOR DIETARY SUPPLEMENTS AND CONVENTIONAL FOODS (SECTION 610 
REVIEW)

Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

Abstract: Section 101.54 (21 CFR part 101.54) describes the 
requirements for when the terms ``high potency'' and ``antioxidant'' 
may be used on the label or in the labeling of foods, including dietary 
supplements. Section 101.60 (21 CFR part 101.60) describes the 
requirements for when the terms ``low calorie'' or ``reduced calorie'' 
may be used on the label or in the labeling of such foods. FDA is 
undertaking a review of sections 101.54 and 101.60 under section 610 of 
the Regulatory Flexibility Act. The purpose of this review is to 
determine whether the regulations 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 regulations in sections 101.54 and 101.60; (2) 
the nature of complaints or comments received concerning the 
regulations; (3) the complexity of the regulations; (4) the extent to 
which the regulations in sections 101.54 and 101.60 overlap, duplicate, 
or conflict with other Federal rules, and to the extent feasible, with 
State or governmental rules; and (5) the degree to which technology, 
economic conditions, or other factors have changed in the area affected 
by the regulations in sections 101.54 and 101.60.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/01/06
End Review                      11/00/07

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: David Zorn, Lead Economist, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition, ORP (HFS-020), 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-1825
Fax: 301 436-2505
Email: david.zorn@fda.hhs.gov

RIN: 0910-AF83
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

319. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS 
AND BIOLOGICS

 Regulatory Plan: This entry is Seq. No. 38 in part II of this issue of 
the Federal Register.

RIN: 0910-AC52
_______________________________________________________________________

320. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND 
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

 Regulatory Plan: This entry is Seq. No. 39 in part II of this issue of 
the Federal Register.

RIN: 0910-AF11
_______________________________________________________________________

321. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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 
will address external analgesic drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/08
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF35
_______________________________________________________________________

322. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 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 products 
marketed for children under 2 years old and weight- and age-based 
dosing for children's products. The third action addresses combination 
products containing the analgesic acetaminophen or aspirin and sodium 
bicarbonate used as an antacid ingredient. The fourth action addresses 
other miscellaneous issues relating to

[[Page 70051]]

internal analgesics. The fifth document finalizes the document 
regarding the required warnings and other labeling. The last document 
finalizes the Internal Analgesic Products monograph.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Required 
Warnings and Other Labeling)    12/26/06                    71 FR 77314
NPRM Comment Period End         05/25/07
NPRM (Amendment) 
(Overindulgence/ Hangover)      06/00/08
NPRM (Amendment) (Pediatric)    12/00/08
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        06/00/08
NPRM (Amendment) (Miscellaneous 
Issues)                         12/00/08
Final Action (Required Warnings 
and Other Labeling)             06/00/08
Final Action (Internal 
Analgesics)                     12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF36
_______________________________________________________________________

323. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. This 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
NPRM (Plaque Gingivitis)        12/00/08
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF40
_______________________________________________________________________

324. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. One action 
addresses sunscreen formulation, labeling, and testing requirements for 
both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, 
and the other action addresses combination products containing 
sunscreen and insect repellent ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      02/22/07                     72 FR 7941
ANPRM Comment Period End        05/23/07
NPRM (UVA/UVB)                  08/27/07                    72 FR 49070
NPRM (Sunscreen and Insect 
Repellent)                      12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF43
_______________________________________________________________________

325. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE 
UNITED STATES

 Regulatory Plan: This entry is Seq. No. 40 in part II of this issue of 
the Federal Register.

RIN: 0910-AF61
_______________________________________________________________________

326. OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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 ipecac syrup.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (IPECAC)                   12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF68
_______________________________________________________________________

327. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355;

[[Page 70052]]

21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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 
action addresses food handler products. The second action addresses 
testing requirements. The last action addresses healthcare antiseptic 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Food Handlers)            12/00/08
NPRM (Testing)                  06/00/08
Final Action (Healthcare)       12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF69
_______________________________________________________________________

328. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. This action 
addresses the products used for urinary pain relief.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic)        12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF70
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

329. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 
USC 263; 42 USC 263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 
USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 
360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 
USC 381

Abstract: These regulations are one component of the Secretary's 
initiative to reduce medical errors. The final rule would amend the 
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.

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                    07/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________

330. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

 Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of 
the Federal Register.

RIN: 0910-AB88
_______________________________________________________________________

331. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

 Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of 
the Federal Register.

RIN: 0910-AC14
_______________________________________________________________________

332. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUGS

Legal Authority: 21 USC 355b

Abstract: To require the labeling of human drugs approved under section 
505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free 
number for reports of adverse events, and a statement that the number 
is to be used for reporting purposes only and not to receive medical 
advice.

[[Page 70053]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/22/04                    69 FR 21778
NPRM Comment Period End         07/21/04
Final Action                    01/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC35
_______________________________________________________________________

333. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

Legal Authority: PL 105-115, sec 121

Abstract: Section 121 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for 
current good manufacturing practices (CGMPs) for positron emission 
tomography (PET) drugs, a type of radiopharmaceutical. The proposed 
rule would adopt CGMPs that reflect the unique characteristics of PET 
drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/20/05                    70 FR 55038
NPRM Comment Period End         12/19/05
Final Action                    04/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: brian.pendleton@fda.hhs.gov

RIN: 0910-AC55
_______________________________________________________________________

334. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

Legal Authority: 21 USC 379e(b)

Abstract: The Agency published a proposed rule on January 30, 2006, to 
require the label declaration of all foods and cosmetics containing the 
color additives cochineal extract and carmine in order to protect 
consumers with allergies to these additives. This proposal was issued 
in response to adverse event reports received by FDA and to a citizen 
petition submitted to FDA. The comment period ended on May 1, 2006. FDA 
intends to issue a final rule after reviewing comments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/06                     71 FR 4839
NPRM Comment Period End         05/01/06
Final Action                    05/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Mical E. Honigfort, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1278
Fax: 301 436-2972
Email: mical.honigfort@fda.hhs.gov

RIN: 0910-AF12
_______________________________________________________________________

335. CHARGING FOR INVESTIGATIONAL DRUGS

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 371; 42 USC 262

Abstract: On December 14, 2006, (71 FR 75168), FDA published a proposed 
rule to amend FDA's investigational new drug regulation concerning 
charging for investigational drugs. The rule will clarify the 
circumstances in which charging for an investigational drug in a 
clinical trial is appropriate, set forth criteria for charging for an 
investigational drug for the different types of treatment uses 
described in the Agency's rule on expanded access to investigational 
drugs for treatment use, and clarify what costs can be recovered for an 
investigational drug. The rule is intended to permit charging for a 
broader range of investigational uses than is explicitly permitted in 
current regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/14/06                    71 FR 75168
NPRM Comment Period End         03/14/07
Final Action                    09/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101, 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: christine.rogers@fda.hhs.gov

RIN: 0910-AF13
_______________________________________________________________________

336. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE

 Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of 
the Federal Register.

RIN: 0910-AF14
_______________________________________________________________________

337. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. This action 
addresses labeling claims for the common cold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Amendment) (Common 
Cold)                           12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF31

[[Page 70054]]

_______________________________________________________________________

338. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. This action 
addresses labeling for these products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment - Ephedrine 
Single Ingredient)              07/13/05                    70 FR 40237
Final Action (Technical 
Amendment)                      03/19/07                    72 FR 12370
Final Action (Amendment - 
Ephedrine Single Ingredient)    06/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF32
_______________________________________________________________________

339. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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 technical 
amendment revises a paragraph designation in the CFR. The other action 
finalizes cough/cold combination products containing oral 
bronchdilators and expectorants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                07/13/05                    70 FR 40232
Final Action (Technical 
Amendment)                      12/00/07
Final Action                    06/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF33
_______________________________________________________________________

340. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. This action 
addresses the ingredient phenyl propanolamine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis 
Claim)                          08/02/04                    69 FR 46119
NPRM (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM (Phenyl propanolamine)     12/22/05                    70 FR 75988
Final Action (Amendment) 
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenylephrine 
Bitartrate)                     08/01/06                    71 FR 83358
Final Action (Phenyl 
propanolamine)                  12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF34
_______________________________________________________________________

341. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR 
OTC HUMAN USE

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 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. 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
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF37
_______________________________________________________________________

342. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

[[Page 70055]]

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. One action will 
address laxative drug products. The other action will address psyllium 
laxative drug products in a granular dosage form.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07                    72 FR 14669
Final Action (Laxative Drug 
Products)                       06/00/08
NPRM (Professional Labeling)    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF38
_______________________________________________________________________

343. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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 labeling for products formulated and marketed as lip 
protectants. The second action addresses skin protectant products used 
to treat fever blisters and cold sores. The third action identifies 
safe and effective skin protectant active ingredients to treat and 
prevent diaper rash. The fourth action addresses astringent active 
ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     12/00/07
Final Action (Fever Blisters/
Cold Sores)                     12/00/08
Final Action (Diaper Rash)      12/00/08
Final Action (Aluminum Acetate) 
(Technical Amendment)           12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF42
_______________________________________________________________________

344. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 360a; 21 USC 360gg to 360ss; 21 USC 
371; 21 USC 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 264

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. One action will 
address labeling warning statements for products containing Nonoxynol 
9. The other action addresses vaginal contraceptive drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Vaginal Contraceptive Drug 
Products)                       06/00/08
Final Action (Warnings)         12/00/07

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF44
_______________________________________________________________________

345. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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. One action 
addresses the ingredient phenylpropanolamine, and the other action 
addresses the ingredient benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl propanolamine)     12/22/05                    70 FR 75988
NPRM (Benzocaine)               12/00/08
Final Action (Phenyl 
propanolamine)                  12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF45
_______________________________________________________________________

346. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT 
THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371

[[Page 70056]]

Abstract: On October 6, 2005, the Food and Drug Administration (FDA) 
proposed to amend its regulations to prohibit the use of certain cattle 
origin materials in the food or feed of all animals to help strengthen 
existing safeguards to prevent the spread of bovine spongiform 
encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive 
dairy cow in December 2003 has caused FDA to review its policies for 
prevention of BSE, which resulted in this rulemaking.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/14/04                    69 FR 42288
ANPRM Comment Period End        08/13/04
NPRM                            10/06/05                    70 FR 58569
NPRM Comment Period End         12/20/05
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Burt Pritchett, Biologist, Department of Health and 
Human Services, Food and Drug Administration, Center for Veterinary 
Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: burt.pritchett@fda.hhs.gov

RIN: 0910-AF46
_______________________________________________________________________

347. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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. 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

________________________________________________________________________

Final Action (Sodium Bicarbonate 
Labeling)                       06/00/08
Final Action (Overindulgence 
Labeling)                       12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF52
_______________________________________________________________________

348. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. 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
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF53
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________

349. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 
21 USC 379

Abstract: The Food and Drug Administration (FDA) published a proposed 
regulation on October 29, 2003 (68 FR 61640), that would amend its 
regulations on submission of bioequivalence (BE) data to require an 
abbreviated new drug application (ANDA) applicant to submit data from 
all BE studies the applicant conducts on a drug product formulation 
submitted for approval. In the past, ANDA applicants have submitted BE 
studies demonstrating that a generic product meets BE criteria for FDA 
to approve the ANDA but have not typically submitted additional BE 
studies conducted on the same drug product formulation. If finalized, 
this rule would require ANDA applicants to submit information, in 
either a complete or summary report, from all additional passing and 
nonpassing BE studies conducted on the same drug product formulation 
submitted for approval.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/29/03                    68 FR 61640
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101,

[[Page 70057]]

5515 Security Lane, Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC23
_______________________________________________________________________

350. HEALTH CLAIMS

Legal Authority: 21 USC 343; 21 USC 371

Abstract: On November 25, 2003 (68 FR 66040), FDA issued an advance 
notice of proposed rulemaking (ANPRM) to request comments on 
alternatives for regulating qualified health claims in the labeling of 
conventional human foods and dietary supplements. FDA also solicited 
comments on various other issues related to health claims and on the 
appropriateness and nature of dietary guidance statements on 
conventional food and dietary supplement labels. This ANPRM was 
signaled in the July 11, 2003 (68 FR 41387), notice that announced the 
availability of the final report of the FDA Task Force on the Consumer 
Health Information for Better Nutrition Initiative.
Comments on the regulatory alternatives and additional topics 
identified in the ANPRM will inform FDA decisions about regulation of 
qualified health claims.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/25/03                    68 FR 66040
ANPRM Comment Period Extended   01/27/04                     69 FR 3868
ANPRM Comment Period End        02/25/04
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Julie Moss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: julie.moss@fda.hhs.gov

RIN: 0910-AF09
_______________________________________________________________________

351. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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 emergency first aid eyewash products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Emergency 
First Aid Eyewashes)            12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF39
_______________________________________________________________________

352. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND 
DRINK PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF51
_______________________________________________________________________

353. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. This action 
addresses the use of stimulant active ingredients to relieve symptoms 
associated with a hangover.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover)     12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF56

[[Page 70058]]

_______________________________________________________________________

354. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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. This action 
addresses products containing antidiarrheal drug ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter Jefferson Ellenberg, Regulatory Project 
Management Officer, Center for Drug Evaluation and Research, Department 
of Health and Human Services, Food and Drug Administration, HFD-560, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF63
_______________________________________________________________________

355. FOOD LABELING; SERVING SIZES; REFERENCE AMOUNT FOR BAKING POWDER, 
BAKING SODA, AND PECTIN (SECTION 610 REVIEW)

Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

Abstract: Section 101.9 (21 CFR part 101.9) describes the nutrition 
labeling regulations for the reference amount customarily consumed per 
eating occasion for the food category ``Baking powder, baking soda, 
pectin.'' Section 101.12 (21 CFR part 101.12) includes 1/8 teaspoon 
(tsp) as an additional allowable household measure. FDA is undertaking 
a review of sections 101.9 and 101.12 under section 610 of the 
Regulatory Flexibility Act. The purpose of this review is to determine 
whether the regulations in sections 101.9 and 101.12 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 regulations in 
sections 101.9 and 101.12; (2) the nature of complaints or comments 
received concerning the regulations in sections 101.9 and 101.12; (3) 
the complexity of the regulations; (4) the extent to which the 
regulations in sections 101.9 and 101.12 overlap, duplicate, or 
conflict with other Federal rules, and to the extent feasible, with 
State or governmental rules; and (5) the degree to which technology, 
economic conditions, or other factors have changed in the area affected 
by the regulations in sections 101.9 and 101.12.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/00/08
End Review                      03/00/09

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: David Zorn, Lead Economist, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition, ORP (HFS-020), 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-1825
Fax: 301 436-2505
Email: david.zorn@fda.hhs.gov

RIN: 0910-AF99
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________

356. MEDICAL DEVICES; CURRENT GOOD MANUFACTURING PRACTICE (CGMP) FINAL 
RULE; QUALITY SYSTEMS REGULATIONS (COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: 5 USC 610

Abstract: FDA has undertaking a review of part 820 under section 610 of 
the Regulatory Flexibility Act. The agency did not receive any comments 
during the review process of part 820 under section 610 review, 
therefore the regulation will continue without change. The purpose of 
the review was to determine whether the regulations in part 820 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 substantial number of small 
entities. FDA has solicited comments on, the following (1) the 
continued need for the regulation in part 820; (2) the nature of 
complaints or comments received concerning the regulation in part 820; 
(3) the complexity of the regulation in part 820; (4) the extent to 
which the regulation in part 820 overlap, duplicate, or conflict with 
other Federal, State, or governmental rules: and (5) the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the regulation in part 820.
The section 610 review has been carried out along with a regulation 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order. The combined effect of 
the two reviews will be to determine if it is possible to redesign 
current good manufacturing practices in ways that will maintain or 
increase the effectiveness of preventive and sanitary controls, and, at 
the same time, reduce compliance and other costs associated with the 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      01/05/06
End Review                      07/31/07

Regulatory Flexibility Analysis Required: No

[[Page 70059]]

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: myrna.hanna@fda.hhs.gov

RIN: 0910-AF71
_______________________________________________________________________

357. PACKAGE SIZE LIMITATION FOR SODIUM PHOSPHATES ORAL SOLUTION AND 
WARNING AND DIRECTION STATEMENTS FOR ORAL AND RECTAL SODIUM PHOSPHATES 
FOR OVER-THE-COUNTER LAXATIVE USE (SECTION 610 REVIEW)

Legal Authority: 5 USC 610

Abstract: Section 201.307 (21 CFR sec. 201.307) describes a final rule 
to limit the container size for sodium phosphates oral solution 
(dibasic sodium phosphate/monobasic sodium phosphate oral solution) to 
not greater than 90 milliliters (mL) (3 ounces (oz) when used as an 
over-the-counter (OTC) laxative drug product. FDA limited the container 
size due to reports of deaths associated with an overdosage of sodium 
phosphates when packaged in a larger size container and a larger-than-
intended dose was ingested inadvertently. In addition, this final rule 
required warning and direction statements to inform consumers that 
exceeding the recommended dose of oral and rectal sodium phosphates 
products in a 24-hour period could be harmful.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 201.307. The purpose of 
this review is to determine whether the regulation in section 201.307 
should be continued without change, or whether it should be further 
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 regulation in section 
201.307; (2) the nature of the complaints or comments received 
concerning the regulation in section 201.307; (3) the complexity of the 
regulation in section 201.307; (4) the extent to which the regulation 
in section 201.307 overlaps, duplicates, or conflicts with other 
Federal, State, or governmental rules; and (5) the degree to which 
technology, economic conditions, or other factors have changed for the 
products still subject to the package size and labeling regulation in 
section 201.307.
The section 610 review has been carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order. During the review, FDA 
received one comment. This comment will be addressed on a future 
rulemaking.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

End Review                      09/04/07

Regulatory Flexibility Analysis Required: No

Agency Contact: Walter Jefferson Ellenberg
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF73
_______________________________________________________________________

358. OVER-THE-COUNTER DRUG PRODUCTS CONTAINING ANALGESIC/ANTIPYRETIC 
ACTIVE INGREDIENTS FOR INTERNAL USE: REQUIRED ALCOHOL WARNING (SECTION 
610 REVIEW)

Legal Authority: 5 USC 610

Abstract: Section 201.322 describes a regulation that requires an 
alcohol warning for all over-the-counter (OTC) drug products, labeled 
for adult use, containing internal analgesic/antipyretic active 
ingredients. The required warning statements advise consumers with a 
history of heavy alcohol use to consult a physician for advice about 
the use of OTC internal analgesic/antipyretic drug products. FDA issued 
the final rule after considering comments on the Agency's proposed 
regulation for OTC internal analgesic, antipyretic, and antirheumatic 
drug products: A proposed regulation to establish an alcohol warning, 
recommendations from its Nonprescription Drugs Advisory Committee 
(NDAC) and Arthritis Drugs Advisory Committee (ADAC), and data 
submitted to the agency.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 201.322. The purpose of 
this review is to determine whether the regulation in section 201.322 
should be continued without change, or whether it should be further 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA proposed to remove section 201.322 in the 
Federal Register on December 26, 2006 (71 FR 77314). FDA will consider 
the comments received in response to that proposal and, in addition, is 
soliciting comments on the following: (1) The continued need for the 
regulation in section 201.322; (2) the nature of the complaints or 
comments received concerning the regulation in section 201.322; (3) the 
complexity of the regulation in section 201.322; (4) the extent to 
which the regulation in section 201.322 overlaps, duplicates, or 
conflicts with other Federal, State, or governmental rules; and (5) the 
degree to which technology, economic conditions, or other factors have 
changed for the products still subject to the labeling regulation in 
section 201.322.
The section 610 review has been carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order. This review concluded 
with the publication of proposed amendment of the tentative final 
monograph; required warnings and other labeling. 71 FR 77314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

End Review                      12/26/06

Regulatory Flexibility Analysis Required: No

Agency Contact: Walter Jefferson Ellenberg

[[Page 70060]]

Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF74
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________

359. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-P) (SECTION 610 REVIEW)

Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 
1395hh; 42 USC 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 requirements 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                     02/00/08

Regulatory Flexibility Analysis Required: No

Agency Contact: Commander Mercedes Benitez-McCrary, Health Insurance 
Specialist, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-05-
14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716
Email: mercedes.benitezmccrary@cms.hhs.gov

Lynn M. Riley, Clinical Standards Group,, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, S3-02-01, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1286
Email: lynn.riley@cms.hhs.gov

RIN: 0938-AG81
_______________________________________________________________________

360. REVISIONS TO HIPAA CODE SETS (CMS-0013-P)

Legal Authority: PL 104-191

Abstract: This proposed rule would revise some of the adopted 
transaction and code set standards detailed in regulations published by 
HHS on August 17, 2000, and February 20, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Denise Buenning, Health Insurance Specialist, Office of 
E-Health Standards and Services, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6711
Email: denise.buenning@cms.hhs.gov

RIN: 0938-AN25
_______________________________________________________________________

361. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS-
2249-P)

Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086

Abstract: This proposed rule would amend the Medicaid regulations to 
define and describe the home and community-based State plan services 
implementing new section 1915(i) of the Social Security Act as added by 
section 6086 of the Deficit Reduction Act of 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Theresa Pratt, Director, Division of Integrated Health 
Systems, Disabled and Elderly Health Programs Group, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9499
Email: theresa.pratt@cms.hhs.gov

RIN: 0938-AO53
_______________________________________________________________________

362. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2009: 
ANNUAL PAYMENT RATE UPDATES (CMS-1393-P)

Legal Authority: sec 123 PL 106-113; sec 307(b) PL 106-554

Abstract: This major rule proposes changes to the Medicare long-term 
care hospitals (LTCH) prospective payment system (PPS) annual updates 
the payment rates for rate year (RY) 2009.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Judith Richter, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C4-16-07, 7500 Security Boulevard, Baltimore
Phone: 410 786-2590
Email: judith.richter@cms.hhs.gov

RIN: 0938-AO94
_______________________________________________________________________

363. <bullet<ls-thn-eq> ESTABLISHING ADDITIONAL MEDICARE PROVIDER AND 
SUPPLIER ENROLLMENT SAFEGUARDS (CMS-6045-P)

Legal Authority: sec. 4312(a) of BBA of 1997

Abstract: This proposed rule would expand existing provider and 
supplier enrollment requirements to obtain or maintain Medicare billing 
privileges.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/08

Regulatory Flexibility Analysis Required: Yes

[[Page 70061]]

Agency Contact: James Bossenmeyer, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop C3-02-16, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9317
Email: james.bossenmeyer@cms.hhs.gov

RIN: 0938-AP01
_______________________________________________________________________

364. <bullet<ls-thn-eq> HOSPICE WAGE INDEX FOR FY 2009 (CMS-1548-P)

Legal Authority: 42 USC 1814(i)(1) and 1814(i)(2)

Abstract: This rule proposes the annual update to the hospice wage 
index for FY 2009. The wage index is used to reflect local differences 
in wage levels. The hospice wage index methodology and values are based 
on recommendations of a negotiated rulemaking advisory committee and 
were originally published on August 8, 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Terri Deutsch, Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mail Stop 
C5-08-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9462
Email: terri.deutsch@cms.hhs.gov

RIN: 0938-AP14
_______________________________________________________________________

365. <bullet<ls-thn-eq> CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE 
PAYMENT SYSTEMS AND FY 2009 RATES (CMS-1390-P)

Legal Authority: sec 1886(b) of the Social Security Act

Abstract: This major rule proposes to revise the Medicare hospital 
Inpatient Prospective Payment Systems (IPPS) for operating and capital-
related costs to implement changes arising from our continuing 
experience with these systems. Under section 106(b)(2) of the Tax 
Relief and Health Care Act of 2006, this rule also proposes to revise 
the wage index adjustment under the hospital IPPS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Marc Hartstein, Deputy Director, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mail Stop 
C4-25-11, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4548
Email: marc.hartstein@cms.hhs.gov

RIN: 0938-AP15
_______________________________________________________________________

366. <bullet<ls-thn-eq> CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE 
PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2009 
(CMS-1404-P)

 Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of 
the Federal Register.

RIN: 0938-AP17
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________

367. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-F) 
(SECTION 610 REVIEW)

 Regulatory Plan: This entry is Seq. No. 52 in part II of this issue of 
the Federal Register.

RIN: 0938-AG82
_______________________________________________________________________

368. HOSPICE CARE CONDITIONS OF PARTICIPATION (CMS-3844-F) (SECTION 610 
REVIEW)

 Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of 
the Federal Register.

RIN: 0938-AH27
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________

369. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-F) (SECTION 610 REVIEW)

Legal Authority: 42 USC 1302; 42 USC 1395hh

Abstract: This rule requires hospitals that transfuse blood and blood 
components to prepare and follow written procedures for appropriate 
action when it is determined that blood and blood products the hospital 
received and transfused are at increased risk for transmitting 
hepatitis C virus (HCV); quarantine prior collections from a donor who 
is at increased risk for transmitting HCV infection; notify transfusion 
recipients, as appropriate, of the need for HCV testing and counseling; 
and maintain records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Interim Final Rule              08/24/07                    72 FR 48562
Interim Final Rule Comment 
Period End                      10/23/07
Final Action                    08/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Mary Collins, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, Mailstop S3-02-01,

[[Page 70062]]

7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3189
Email: mary.collins@cms.hhs.gov

RIN: 0938-AJ29
_______________________________________________________________________

370. SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL EQUIPMENT, 
PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS-6006-F)

Legal Authority: sec 4312(a) of BBA of 1997

Abstract: This rule implements section 4312(a) of the Balanced Budget 
Act of 1997, which requires a Medicare supplier of durable medical 
equipment (DME) to furnish CMS with a surety bond.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/01/07                    72 FR 42001
NPRM Comment Period End         10/01/07
Final Action                    08/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Frank Whelan, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Mailstop, C3-02-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-1302
Email: frank.whelan@cms.hhs.gov

RIN: 0938-AO84
_______________________________________________________________________

371. <bullet<ls-thn-eq> MEDICAID GRADUATE MEDICAL EDUCATION (CMS-2279-F) 
(SECTION 610 REVIEW)

Legal Authority: tTitle XIX; Social Security Act

Abstract: As part of the President's 2008 Budget, this major rule 
establishes that States may not include GME as a reimbursable cost or 
program under their approved Medicaid State Plan. The rule enhances 
fiscal integrity and improves accountability with respect to payment 
for medical services in the Medicaid program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/23/07                    72 FR 28930
NPRM Comment Period End         06/22/07
Final Action                    11/00/08

Regulatory Flexibility Analysis Required: No

Agency Contact: Dianne Heffron, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Centers for 
Medicaid State Operations, Mailstop, S3-13-15, 7500 Security Bouldvard, 
Baltimore, MD 21224
Phone: 410 786-3247
Fax: 410-786-1008
Email: dianne.heffron@cms.hhs.gov

RIN: 0938-AO95
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________

372. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS (CMS-1810-F)

Legal Authority: 42 USC 1877

Abstract: This final rule is the third phase (Phase III) of a final 
rulemaking amending our regulations regarding the physician self-
referral prohibition in section 1877 of the Social Security Act (the 
Act). Specifically, this rule finalizes and responds to public comments 
regarding the Phase II interim final rule with commment period 
published on March 26, 2004. Phase II set forth the self-referral 
prohibition and applicable definitions, interpreted various statutory 
exceptions to the prohibition, and created additional regulatory 
exceptions for arrangements that do not pose a risk of program or 
patient abuse (69 FR 16054). In response to public comments in Phase 
III final rule, we have reduced the regulatory burden on the health 
care industry through the interpretation of statutory exceptions and by 
modifying the exceptions that were created using the Secretary's 
discretionary authority under section 1877(b)(4) of the Act to 
promulgate exceptions for financial relationships that pose no risk of 
program or patient abuse.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/05/07                    72 FR 51012

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Joanne Sinsheimer
Phone: 410 786-4620
Email: jsinsheimer@cms.hhs.gov

Lisa Ohrin
Phone: 410 786-4565
Email: lisa.ohrin@cms.hhs.gov

RIN: 0938-AK67
_______________________________________________________________________

373. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT 
(DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-F)

Legal Authority: PL 108-173, MMA; Deficit Reduction Act of 2005, PL 
109-171, sec 5101

Abstract: Section 302 of the Medicare Modernization Act establishes DME 
competitive bidding. National competitive bidding will provide a 
program for using market forces to set Medicare payment amounts. This 
will create incentives for suppliers to provide quality items and 
services while at the same time providing Medicare with reasonable 
prices for payment. This rule also incorporates provisions from section 
5105 of the DRA of 2005, which concerns beneficiary ownership of 
certain DMEs.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          04/10/07                    72 FR 16794
Final Action                    04/11/07                    72 FR 17002

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Ralph Goldberg
Phone: 410 786-4870
Email: ralph.goldberg@cms.hhs.gov

RIN: 0938-AN14

[[Page 70063]]

_______________________________________________________________________

374. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND 
BIOLOGICALS (CMS-1325-F)

Legal Authority: MMA of 2003, sec 303(d)

Abstract: Section 303(d) of the Medicare Modernization Act requires the 
implementation of a competitive bidding program for Medicare Part B 
drugs not paid on a cost or prospective payment system basis. Beginning 
July 1, 2006, physicians will be given a choice between purchasing 
these drugs and being paid by Medicare under the average sales price 
(ASP) system, or obtaining these drugs from vendors selected in a 
competitive bidding process. If the physician elects to obtain drugs 
from a competitive vendor, the vendor will bill Medicare for the drug.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/08/07

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Corinne Axelrod
Phone: 410 786-5620
Email: corinne.axelrod@cms.hhs.gov

RIN: 0938-AN58
_______________________________________________________________________

375. MEDICAID PRESCRIPTION DRUGS--AVERAGE MANUFACTURER PRICE (CMS-2238-
FC)

Legal Authority: 42 USC 1396r.8; Deficit Reduction Act of 2005, PL 109-
171, sec 6001 to 6003

Abstract: This final rule implements sections 6001, 6002, and 6003 of 
the Deficit Reduction Act of 2005. This rule sets the Federal upper 
reimbursement limit (FUL) as 250 percent of the average manufacturer 
price (AMP) for drugs on the FUL list, and will clarify the 
requirements and manner in which AMPs are determined for multiple-
source drugs and other drug payment revisions. This rule also lists the 
physician administered multiple-source drugs that the Secretary 
determines have the highest dollar volume of dispensing in Medicaid and 
will require manufacturers to include authorized generics when they 
report their AMP and best price for covered outpatient drugs to the 
Secretary.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/17/07                    72 FR 39142

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Yolanda Lashawn Reese
Phone: 410 786-9898
Fax: 410 786-5882
Email: yolanda.reese@cms.hhs.gov

RIN: 0938-AO20
_______________________________________________________________________

376. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2008: 
ANNUAL PAYMENT RATE UPDATES AND POLICY CHANGES (CMS-1529-F)

Legal Authority: PL 106-113, sec 123 ; PL 106-554, sec 307(b)

Abstract: This rule finalizes the annual payment rate update for the 
Rate Year (RY) 2008 prospective payment system for Medicare long-term 
care hospitals and also presents proposed changes or revisions on LTCH 
PPS policy for public comment.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/11/07                    72 FR 26870

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Judy Richter
Phone: 410 786-2590
Email: judith.richter@cms.hhs.gov

RIN: 0938-AO30
_______________________________________________________________________

377. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE 
FOR CALENDAR YEAR 2008 (CMS-1541-F)

Legal Authority: Social Security Act, sec 1102 and 1871; (42 USC 1302 
and 1395 (hh))

Abstract: This rule, CMS-1541-F, estimates the net impact, including a 
2.75 percent reduction to the case-mix weights to account for nominal 
increase in case-mix, to be approximately $20 million in CY 2008 
expenditures. That estimate incorporates the 3.0 percent home health 
market basket increase (an estimated additional $430 million in CY 2008 
expenditures attributable only to the CY 2008 home health market basket 
update), and the 2.75 percent decrease (-$410 million for the first 
year of a 3-year phase in) to the HH PPS national standardized 60-day 
episode rate to account for the nominal increase in case-mix under the 
HH PPS.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/04/07                    72 FR 25356
Final Action                    08/29/07                    72 FR 49761

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Randy L. Throndset
Phone: 410 786-0131
Email: randy.throndset@cms.hhs.gov

RIN: 0938-AO32
_______________________________________________________________________

378. COST LIMITS FOR GOVERNMENTALLY-OPERATED PROVIDERS (CMS-2258-FC) 
(COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: sec 1102 of the Social Security Act (42 USC 1302)

Abstract: The final rule with comment will: (1) Clarify that only units 
of government are able to participate in the financing of the non-
Federal share; (2) establish minimum requirements for documenting cost 
when using a certified public expenditure; (3) limit providers operated 
by units of government to reimbursement that does not exceed the cost 
of providing covered services to eligible Medicaid recipients; and (4) 
establish a new regulatory provision explicitly requiring that provders 
receive and retain the total computable amount of their Medicaid 
payments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/07                     72 FR 2236
NPRM Comment Period End         03/19/07
Final Action                    05/29/07                    72 FR 29748

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Aaron Blight, Technical Director, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Center 
for Medicaid State Operations, Mailstop S2-01-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9560
Fax: 410786-1008
Email: aaron.blight@cms.hhs.gov

RIN: 0938-AO57

[[Page 70064]]

_______________________________________________________________________

379. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES 
FOR FY 2008 (CMS-1551-F)

Legal Authority: SSA, sec 1886(i); PL 105-33; PL 106-554; PL 106-113

Abstract: This rule updates rates for the prospective payment system 
for inpatient rehabilitation facilities for FY 2008.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/08/07                    72 FR 26230
Final Action                    08/07/07                    72 FR 44283

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William Ullman
Phone: 410 786-5667
Email: bill.ullman@cms.hhs.gov

RIN: 0938-AO63
_______________________________________________________________________

380. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2008 (CMS-1545-F)

Legal Authority: Social Security Act, sec 1888(e)

Abstract: This proposed rule updates the payment rates used under the 
prospective payment system (PPS) for skilled nursing facilities (SNFs), 
for fiscal year (FY) 2008. In addition, this rule revises and rebase 
the SNF market basket.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/04/07                    72 FR 25526
Final Action                    08/03/07                    72 FR 43412

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William Ullman
Phone: 410 786-5667
Email: bill.ullman@cms.hhs.gov

RIN: 0938-AO64
_______________________________________________________________________

381. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND 
FY 2008 RATES (CMS-1533-FC)

Legal Authority: sec 1886(d) of the Social Security Act

Abstract: This rule proposes to revise the Medicare hospital inpatient 
prospective payment systems (IPPS) for operating and capital-related 
costs to implement changes arising from our continuing experience with 
these systems.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/07                    72 FR 24680
Final Action                    08/22/07                    72 FR 47130

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Marc Hartstein
Phone: 410 786-4548
Email: marc.hartstein@cms.hhs.gov

RIN: 0938-AO70
_______________________________________________________________________

382. HOSPICE WAGE INDEX FOR FY 2008 (CMS-1539-F)

Legal Authority: 42 USC 1814(i)(1) and 1814(i)(2)

Abstract: This rule updates the hospice wage index for FY 2008. The 
wage index is used to reflect local differences in wage levels. The 
hospice wage index methodology and values are based on recommendations 
of a negotiated rulemaking advisory committee and were originally 
published on August 8, 1997.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/01/07                    72 FR 24116
Final Action                    08/31/07                    72 FR 50214

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Terri Deutsch
Phone: 410 786-9462
Email: terri.deutsch@cms.hhs.cms

RIN: 0938-AO72
_______________________________________________________________________

383. REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY 
SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-F)

Legal Authority: 42 USC 1833(i)(2)(D)(iii)

Abstract: This rule revises the method by which Medicare sets payment 
rates for ASC facility services and includes illustrative new payment 
rates for ASC services in accordance with that methodology. This rule 
finalizes policies proposed as part of the August 23, 2006, CY 2007 
Outpatient Prospective Payment System rule.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/02/07                    72 FR 42470

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kim Neuman
Phone: 410 786-7802
Email: kim.neuman@cms.hhs.gov

RIN: 0938-AO73
_______________________________________________________________________

384. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR CY 2008 
(CMS-1552-N)

Legal Authority: sec 1834 (e) of the Social Security Act

Abstract: This notice updates the fee schedule for ambulance services 
under the Medicare program, implementing section 1834(e) of the Social 
Security Act (effective January 1, 2008).

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/08/07

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Anne Tayloe
Phone: 410 786-4546
Email: anne.tayloe@cms.hhs.gov

RIN: 0938-AO85
[FR Doc. 07-04897 Filed 12-07-07; 8:45 am]
BILLING CODE 4150-24-S