64958 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 

misleading; (5) developing a sound 

science base for dietary supplement 

regulation through enhanced research 

and analytical capabilities and 

collaboration with governmental and 

external partners; and (6) expanding 

outreach to stakeholders.

The strategy now being announced 

describes a series of specific, integrated 

steps that will bring CFSAN closer to 

achieving each of its longer-term goals 

for DSHEA implementation and 

enforcement under the 10-year plan. 

This strategy also is consistent with the 

‘‘Dietary Supplement Enforcement 

Report’’ announced in December 2002 

(http://www.fda.gov/oc/mcclellan/

chbn.html), and it incorporates and is in 

furtherance of CFSAN’s 2004 Program 

Priorities, announced in May 2004 

(http://www.cfsan.fda.gov/~dms/

cfsan404.html). We are making this 

strategy available to maximize the 

sharing of information among the 

agency, consumers, and stakeholders 

about implementation of DSHEA.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this strategy. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, 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 strategy 

and received comments may be seen in 

the Division of Dockets Management 

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

through Friday.

III. Electronic Access

Person with access to the Internet may 

obtain the document at http://

www.cfsan.fda.gov/~dms/ds-stra3.html.

Dated: October 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24870 Filed 11–4–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0465]

Draft Guidance for Food and Drug 

Administration Review Staff and 

Sponsors: Content and Review of 

Chemistry, Manufacturing, and Control 

Information for Human Gene Therapy 

Investigational New Drug Applications; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for FDA Review Staff and 

Sponsors: Content and Review of 

Chemistry, Manufacturing, and Control 

(CMC) Information for Human Gene 

Therapy Investigational New Drug 

Applications (INDs)’’ dated November 

2004. The draft guidance document, 

when finalized, is intended to provide 

guidance to FDA review staff and 

sponsors of human gene therapy 

products on IND submissions, and on 

the information FDA CMC reviewers 

record and assess as part of the review 

of an original IND.

DATES: Submit written or electronic 

comments on the draft guidance by 

February 7, 2005, to ensure their 

adequate consideration in preparation of 

the final document. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, suite 200N, 1401 

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive 

label to assist the office in processing 

your requests. The draft guidance may 

also be obtained by mail by calling the 

CBER Voice Information System at 1–

800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

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.

FOR FURTHER INFORMATION CONTACT:

Nathaniel L. Geary, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

FDA Review Staff and Sponsors: 

Content and Review of Chemistry, 

Manufacturing, and Control (CMC) 

Information for Human Gene Therapy 

Investigational New Drug Applications 

(INDs)’’ dated November, 2004. The 

document provides guidance to help 

sponsors and reviewers to assess, given 

the phase of the investigation, whether 

an IND provides sufficient information 

to allow the reviewer to evaluate the 

proper identification (identity testing), 

quality, purity, and strength (potency) of 

the investigational product (21 CFR 

312.23(a)(7)(i)). The draft guidance 

document is intended to help ensure 

that all applicable regulatory 

requirements are reviewed for the 

appropriate stage of product 

development.

The 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 this topic. 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 requirement 

of the applicable statutes and 

regulations.

II. Comments

The draft guidance document is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. Submit written or electronic 

comments to ensure adequate 

consideration in preparation of the final 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in the brackets in 

the heading of this document. A copy of 

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:/

Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64959

1This date was extended to November 7, 2004.

/www.fda.gov/cber/guidelines.htm or 

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

default.htm.

Dated: November 1, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24879 Filed 11–8–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0554]

Compliance Policy Guide Regarding 

Prior Notice of Imported Food Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised Compliance 

Policy Guide (CPG) entitled ‘‘Prior 

Notice of Imported Food Under the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 

2002.’’ The CPG provides written 

guidance to FDA’s and Customs and 

Border Protection’s (CBP’s) staff on 

enforcement of section 307 of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(the Bioterrorism Act) and the agency’s 

implementing regulations, which 

require prior notice for food imported or 

offered for import into the United 

States. The CPG has been revised to 

provide additional guidance to FDA and 

CBP staff regarding prior notice 

submissions that do not provide 

information about the identity of the 

manufacturing facility of food no longer 

in its natural state, articles of food 

imported or offered for import by 

express courier, prior notice submission 

time frames, and lastly, gift packs 

purchased or otherwise acquired by an 

individual and imported or offered for 

import for nonbusiness purposes.

DATES: This guidance is final and 

effective on November 8, 2004. 

However, you may submit written or 

electronic comments at any time.

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Compliance Policy (HFC–

230), Office of Enforcement, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance may be sent.

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), 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 guidance 

document.

FOR FURTHER INFORMATION CONTACT:

Domenic Veneziano, Office of 

Regulatory Affairs (HFC–100), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 703–621–

7809.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

revised CPG section 110.310 entitled 

‘‘Prior Notice of Imported Food Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002.’’ This revised 

guidance is issued with CBP 

concurrence and explains to FDA and 

CBP staff the new FDA and CBP policies 

on enforcement of section 307 of the 

Bioterrorism Act and its implementing 

regulations, which require prior notice 

to FDA of all food imported or offered 

for import into the United States (68 FR 

58974, October 10, 2003 (codified at 21 

CFR part 1, subpart I, 1.276 through 

1.285)). The original CPG was published 

December 2003, and was revised June 

2004 to include additional guidance 

regarding food imported or offered for 

import for noncommercial purposes 

with a noncommercial shipper. In 

August 2004, the CPG was revised to 

provide additional guidance regarding 

food imported or offered for import for 

quality assurance, research or analysis 

purposes only, not for human or animal 

consumption and not for resale. We 

(FDA) also revised the CPG in August to 

extend until November 1, 2004,1 our 

enforcement discretion policy 

concerning certain violations related to 

the registration number of the 

manufacturing facility and the shipper, 

the airway bill number or bill of lading 

number, and the name and address of 

the ultimate consignee.

A. Identity of the Manufacturer

FDA is revising the CPG to provide 

additional guidance regarding prior 

notice submissions that do not provide 

information to identify the 

manufacturing facility of an article of 

food (i.e., the specific facility that 

manufactured the food). This 

information is required for food that is 

no longer in its natural state. FDA and 

CBP intend to exercise broad 

enforcement discretion when this 

information is required but is not 

provided, under the following 

circumstances:

(1) If, after a good faith effort, the 

person submitting prior notice does not 

know the registration number of the 

facility that manufactured the food and 

the facility is required to be registered, 

that person instead provides the name 

and full address of the facility that 

manufactured the food.

(2) If, after a good faith effort, the 

person submitting prior notice does not 

know either the registration number or 

the name and full address of the facility 

that manufactured the food, that person 

instead provides the name and full 

address of the headquarters of the 

facility that manufactured the food.

(3) If, after a good faith effort, the 

person submitting prior notice does not 

know either the information described 

in (1) about the facility that 

manufactured the food, or in (2) about 

the headquarters of the facility that 

manufactured the food, that person 

instead provides the name and full 

address of the invoicing firm.

FDA is taking these steps to provide 

additional flexibility in filing prior 

notice to various kinds of importers 

while the final prior notice rule is under 

development. However, if the facility 

that manufactured the food is a foreign 

facility that is required to be registered 

and either its registration number is not 

provided or the name and address of a 

different facility (i.e., the manufacturing 

facility’s headquarters or the invoicing 

firm) is provided, then it will be more 

difficult and/or may take more time for 

FDA and CBP to verify the identity of 

the manufacturing facility and its 

registration status and to determine 

whether the article of food is subject to 

being held under section 801(l) of the 

Federal Food, Drug, and Cosmetic Act 

(the act). As a result, if an article of food 

is imported or offered for import with 

the manufacturer’s name and full 

address, or the name and address of the 

manufacturing facility’s headquarters or 

the invoicing firm, instead of the 

manufacturer’s name and registration 

number, and if FDA has concerns that 

the food may pose a serious health 

threat, then the food may be delayed at 

the port of arrival until the verification 

is completed. Moreover, as with other 

types of prior notice violations, FDA 

may consider the failure to provide 

required information about the 

manufacturer as a factor in determining 

whether and where to examine the 

article of food. Under all circumstances,