Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Notices 70153

We note that Mr. Bhutani has 

petitioned the U.S. Supreme Court for 

writ of certiorari of the Seventh Circuit’s 

decision in his case. Should the 

outcome of further judicial proceeding 

result in Mr. Bhutani’s conviction being 

reversed, under section 306(d)(3)(B)(i) of 

the act, the order of debarment will be 

withdrawn. Mr. Bhutani may file an 

application to terminate his debarment, 

under section 306(d)(4)(A) of the act. 

Any such application would be 

reviewed under the criteria and 

processes set forth in section 

306(d)(4)(C) and (d)(4)(D) of the act. 

Such an application should be 

identified with Docket No. 2002N–0291 

and sent to the Division of Dockets 

Management (see ADDRESSES). All such 

submissions are to be filed in four 

copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(f). Publicly 

available submissions may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday.

Dated: November 24, 2004.

John M. Taylor,

Associate Commissioner for Regulatory 

Affairs.

[FR Doc. 04–26532 Filed 12–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0493]

Draft Guidance for Industry on 

Recommended Approaches to 

Integration of Genetic Toxicology 

Study Results; 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availability of a draft guidance for 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 ‘‘Recommended 

Approaches to Integration of Genetic 

Toxicology Study Results.’’ This draft 

guidance is intended to inform industry 

on how the Center for Drug Evaluation 

and Research (CDER) views positive 

findings in genetic toxicology assays, 

and to provide recommendations to 

industry on how to proceed in assuring 

safety of healthy subjects or patients 

when results in genotoxicity studies 

suggest a potential cancer or genetic 

hazard.

DATES: Submit written or electronic 

comments on the draft guidance by 

January 31, 2005. General comments on 

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single copies of the draft guidance to the 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 INFORMATIONsection 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

David Jacobson-Kram, Center for Drug 

Evaluation and Research (HFD–024), 

Food and Drug Administration, 5515 

Security Lane, Rockville, MD 20852, 

301–443–5346.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Recommended Approaches to 

Integration of Genetic Toxicology Study 

Results.’’ Risk for carcinogenesis is 

usually determined in rodent assays, in 

either 2–year studies or shorter-term 

studies using alternative models (ICH 

S1B). Regulatory decisions involving 

both single- and repeat-dose clinical 

studies are discussed in this guidance. 

Pharmaceuticals administered through 

oral, intravenous, topical, and other 

routes, as appropriate, are subject to this 

guidance.

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 recommended approaches to 

integration of genetic toxicology study 

results. 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 

paper copies of mailed comments are to 

be submitted, except that individuals 

may submit one paper 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 either http:/

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

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

default.htm.

Dated: November 23, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26533 Filed 12–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Longitudinal 

Investigation of Fertility and the 

Environment

SUMMARY: Under the provisions of 

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

Reduction Act of 1995, the National 

Institute of Child Health and Human 

Development, the National Institutes of 

Health has submitted to the Office of 

Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register, under the title ‘‘Determinants 

of Male and Female Fecundity and 

Fertility,’’ on January 9, 2004, page 1589 

and allowed 60-days for public 

comment. Two public comments were 

received from the American Society for 

Reproductive Medicine and the 

American Chemistry Council Phthalate 

Esters Panel regarding specific aspects 

of the proposed methodology. Overall, 

comments from the former group 

pertained predominantly to clinical 

issues while the latter group’s 

comments provided their rationale for 

the omission of phthalates from the 

protocol. These comments were useful 

in modifying the proposed study and 

instruments. The purpose of this notice 

is to allow an additional 30 days for 

public comment. 

5 CFR 1320.5 (General Requirements) 

Reporting and Recordkeeping 

Requirements: Final Rule requires 

that the agency inform the potential