Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 75985

address at http://www.cms.hhs.gov/

regulations/pra/, or e-mail your request, 

including your address, phone number, 

OMB number, and CMS document 

identifier, to Paperwork@cms.hhs.gov, 

or call the Reports Clearance Office on 

(410) 786–1326. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 60 days of this notice directly to 

the CMS Paperwork Reduction Act 

Reports Clearance Officer designated at 

the address below: 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development, Attention: 

Melissa Musotto, Room C5–14–03, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850.

Dated: December 8, 2004. 

John P. Burke, III, 

CMS Paperwork Reduction Act Reports 

Clearance Officer, Office of Strategic 

Operations and Regulatory Affairs 

Regulations Development Group.

[FR Doc. 04–27705 Filed 12–17–04; 8:45 am] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Advisory Committees; Tentative 

Schedule of Meetings for 2005

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

tentative schedule of forthcoming 

meetings of its public advisory 

committees for 2005. During 1991, at the 

request of the Commissioner of Food 

and Drugs (the Commissioner), the 

Institute of Medicine (the IOM) 

conducted a study of the use of FDA’s 

advisory committees. In its final report, 

one of the IOM’s recommendations was 

for the agency to publish an annual 

tentative schedule of its meetings in the 

Federal Register. This publication 

implements the IOM’s recommendation.

FOR FURTHER INFORMATION CONTACT:

Theresa L. Green, Advisory Committee 

Oversight and Management Staff (HF–

4), Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–1220.

SUPPLEMENTARY INFORMATION: The IOM, 

at the request of the Commissioner, 

undertook a study of the use of FDA’s 

advisory committees. In its final report 

in 1992, one of the IOM’s 

recommendations was for FDA to adopt 

a policy of publishing an advance yearly 

schedule of its upcoming public 

advisory committee meetings in the 

Federal Register; FDA has implemented 

this recommendation. The annual 

publication of tentatively scheduled 

advisory committee meetings will 

provide both advisory committee 

members and the public with the 

opportunity, in advance, to schedule 

attendance at FDA’s upcoming advisory 

committee meetings. Because the 

schedule is tentative, amendments to 

this notice will not be published in the 

Federal Register. However, changes to 

the schedule will be posted on the FDA 

advisory committees’ Internet site 

located at http://www.fda.gov/oc/

advisory/default.htm. FDA will 

continue to publish a Federal Register

notice 15 days in advance of each 

upcoming advisory committee meeting, 

to announce the meeting (21 CFR 14.20).

The following list announces FDA’s 

tentatively scheduled advisory 

committee meetings for 2005. You may 

also obtain up-to-date meeting 

information by calling the Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area).

Committee Name Tentative Date(s) of Meetings 

Advisory Committee 10–

Digit Information Line 

Code 

OFFICE OF THE COMMISSIONER

Pediatric Advisory Committee February 14–15, June-day to be announced, November-day to be announced8732310001

Science Board to the Food and Drug Administration April 15, November-day to be announced 3014512603

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Allergenic Products Advisory Committee April 7 3014512388

Cellular, Tissue and Gene Therapies Advisory Committee 

(formerly Biological Response Modifiers Advisory Committee)

March 3–4, July 28–29, November 9–10 3014512389

Blood Products Advisory Committee March 17–18, July 21–22, December 1–2 3014519516

Transmissible Spongiform Encephalopathies Advisory 

Committee

February 8–9, June 28–29, October 27–28 3014512392

Vaccines and Related Biological Products Advisory CommitteeFebruary 16–17, March 15–16, May 4–5, September 

20–21, November 16–17

3014512391

CENTER FOR DRUG EVALUATION AND RESEARCH

Anesthetic and Life Support Drugs Advisory Committee May 24–25, July 20–21, November 9–10 3014512529

Anti-Infective Drugs Advisory Committee To Be Announced 3014512530

Antiviral Drugs Advisory Committee March 10–11, August 3–4 3014512531

Arthritis Advisory Committee February 16–17, May 12–13, September 15–16 3014512532

75986 Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 

Committee Name Tentative Date(s) of Meetings 

Advisory Committee 10–

Digit Information Line 

Code 

Cardiovascular and Renal Drugs Advisory Committee February 24, April 5–6, June 15–16, August 17–18, 

November 16–17

3014512533

Dermatologic and Ophthalmic Drugs Advisory Committee March 24–25—Joint Meeting with Nonprescription 

Drugs Advisory Committee, June 2–3, October 20–21, 

November 3–4

3014512534

Drug Safety and Risk Management Advisory Committee March 8–9—Joint Meeting with Gastrointestinal Drugs 

Advisory Committee, June 2–3, October 20–21, November 3–4

3014512535

Endocrinologic & Metabolic Drugs Advisory Committee January 13–14—Joint Meeting with Nonprescription 

Drugs Advisory Committee, May 5–6, September 22–

23, December 13–14

3014512536

Gastrointestinal Drugs Advisory Committee March 9—Joint Meeting with Drug Safety and Risk 

Management Advisory Committee, March 10, October–day to be announced

3014512538

Nonprescription Drugs Advisory Committee January 13–14–Joint Meeting with Endocrinologic and 

Metabolic Drugs Advisory Committee 

March 23–25—Joint Meeting with Dermatologic and 

Ophthalmic Drugs Advisory Committee

3014512541

Oncologic Drugs Advisory Committee March 2–3, May 11–12, September 13–14, December 

7–8

3014512542

Peripheral and Central Nervous System Drugs May 4 3014512543

Pharmaceutical Science, Advisory Committee for (Parent 

Committee)

April, October—Parent Committee-days to be announced 

April, November—Clinical Pharmacology Subcommittee-days to be announced 

March, June, September—Manufacturing Subcommittee-days to be announced

3014512539

Psychopharmacologic Drugs Advisory Committee To be announced 3014512544

Pulmonary-Allergy Drugs Advisory Committee April 27–28, August 30–31, December 12–13 3014512545

Reproductive Health Drugs, Advisory Committee for To be announced 3014512537

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

Device Good Manufacturing Practice Advisory Committee December-day to be announced 3014512398

Medical Devices Advisory Committee (Comprised of 18 Panels)

Anesthesiology and Respiratory Therapy Devices Panel April 25–26, November 3–4 3014512624

Circulatory System Devices Panel January 13, March 17, May 19, July 21, September 

22, November 17

3014512625

Clinical Chemistry and Clinical Toxicology Devices Panel March 21–22, April 21–22, May 23–24, July 11–12, 

September 8–9, December 5–6

3014512514

Dental Products Panel April 11–12, July 18–19 3014512518

Ear, Nose, and Throat Devices Panel February 24–25, April 28–29, June 20–21, August 1–

2, October 6–7, December 1–2

3014512522

Gastroenterology-Urology Devices Panel March 4, May 3, July 22, October 21 3014512523

General and Plastic Surgery Devices Panel February 7–8, June 9–10, August 25–26, November 

7–8

3014512519

General Hospital and Personal Use Devices Panel February 10–11, May 9–10, August 8–9, December 

5–6

3014512520

Hematology and Pathology Devices Panel April 29, October 21 3014512515

Immunology Devices Panel May 19, November 10 3014512516

Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 75987

Committee Name Tentative Date(s) of Meetings 

Advisory Committee 10–

Digit Information Line 

Code 

Medical Devices Dispute Resolution Panel Meeting(s) scheduled as needed 3014510232

Microbiology Devices Panel March 31–April 1, June 16–17, September 19–20, 

December 8–9

3014512517

Molecular and Clinical Genetics Panel April 18–19, October 17–18 3014510231

Neurological Devices Panel April 28–29, June 20–21, September 22–23, December 1–23014512513

Obstetrics and Gynecology Devices Panel March 10–11, May 16–17, August 15–16, November 

14–15

3014512524

Ophthalmic Devices Panel March 17–18, May 12–13, July 28–29, September 

29–30, November 17–18

3014512396

Orthopaedic and Rehabilitation Devices Panel January 31–February 1, April 7–8, July 25–26, November 3– 43014512521

Radiological Devices Panel February 1, May 10, August 2, November 1 3014512526

National Mammography Quality Assurance Advisory CommitteeApril 18 3014512397

Technical Electronic Product Radiation Safety Standards 

Committee

May 18 3014512399

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

Food Advisory Committee—Parent July-day to be announced 3014510564

Additives and Ingredients Subcommittee June-day to be announced Do.

Biotechnology Subcommittee July-day to be announced Do.

Contaminants and Natural Toxicants Subcommittee November-day to be announced Do.

Dietary Supplements Subcommittee To be announced Do.

Infant Formula Subcommittee August-day to be announced Do.

Nutrition Subcommittee To be announced Do.

CENTER FOR VETERINARY MEDICINE

Veterinary Medicine Advisory Committee January 31, May 19, October 20 3014512548

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR)

Science Advisory Board to NCTR March 30–31 3014512559

Advisory Committee on Special Studies Relating to the 

Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants

May, September, November-days to be announced 3014512560

Dated: December 8, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–27737 Filed 12–17–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0524]

Draft Guidance for Industry on ANDAs: 

Pharmaceutical Solid Polymorphism; 

Chemistry, Manufacturing, and 

Controls Information; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘ANDAs: 

Pharmaceutical Solid Polymorphism; 

Chemistry, Manufacturing, and Controls 

Information.’’ The draft guidance is 

intended to assist applicants with the 

submission of abbreviated new drug 

applications (ANDAs) when a drug 

substance exists in polymorphic forms.

DATES: Submit written or electronic 

comments on the draft guidance by 

March 21, 2005. General comments on