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Draft Guidance for Industry on ANDAs: 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 

75988 Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Andre Raw, Center for Drug Evaluation 

and Research (HFD–620), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

5758.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘ANDAs: Pharmaceutical Solid 

Polymorphism; Chemistry, 

Manufacturing, and Controls 

Information.’’ This draft guidance 

provides: (1) A framework for making 

regulatory decisions on drug substance 

sameness in terms of polymorphic form, 

and (2) decision trees which provide a 

recommended course to monitor and 

control polymorphs in the drug 

substance and/or drug product when the 

drug substance exists in relevant 

polymorphic forms.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on pharmaceutical solid polymorphism. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of any comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: December 11, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–27736 Filed 12–17–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; The Framingham 

Study

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of the Management and Budget (OMB) 

a request for review and approval the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on March June 30, 2004, page 

39486, and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: The 

Framingham Study. Type of Information 

Collection Request: Reinstatement of a 

currently approved collection (OMB No. 

0925–0216). Need and Use of 

Information Collection: This study will 

conduct examinations and morbidity 

and mortality follow-up in original, 

offspring, and third-generation 

participants to study the determinants 

of cardiovascular disease. Frequency of 

Response: The participants will be 

contacted annually. Affected Public:

Individuals or households, businesses 

or other for profit, small businesses or 

organizations. Type of Respondents:

Adult men and women; doctors and 

staff of hospitals and nursing homes. 

The annual reporting burden is as 

follows: Estimated Number or 

Respondents: 5,649; Estimated Number 

of Responses Per Respondent: 2.29; 

Average Burden Hours Per Response:

0.6; and Estimated Total Annual Burden 

Hours Requested: 6,886. There are no 

capital, operating or maintenance costs 

to report.

Type of respondents 

Estimated 

number of respondents 

Estimated 

number of responses per 

respondent 

Average burden hours per 

response 

Estimated total 

annual burden 

hours requested 

Participants ...................................................................................................... 3,513 2.86 0.606 6,085

Physician, hospital, nursing home staff ........................................................... 1,068 1.0 0.67 716

Participant’s next of kin ................................................................................... 1,068 1.0 .08 85

Total .......................................................................................................... 6,649 2.29 ........................ 6,886

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) minimize the burden 

of the collection of information on those