Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64957

Dated: November 3, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–24893 Filed 11–8–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0480]

The Minor Use and Minor Species 

Animal Health Act; Request for 

Comments

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

establishment of a new Office of Minor 

Use and Minor Species (MUMS) Animal 

Drug Development and is requesting 

comments on the implementation of the 

newly enacted MUMS Animal Health 

Act. This notice is intended to provide 

the public with contact information for 

the new MUMS office as well as to 

provide a venue for public comment.

DATES: Submit written or electronic 

comments by January 10, 2005.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to www.fda.gov/

dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Andrew Beaulieu, Office of Minor Use 

and Minor Species Animal Drug 

Development, Center for Veterinary 

Medicine, 7519 Standish Pl., Rockville, 

MD 20855, 301–827–2945, 

abeaulie@cvm.fda.gov. Alternatively, 

you may contact Margaret Oeller, Office 

of Minor Use and Minor Species Animal 

Drug Development, Center for 

Veterinary Medicine, 7519 Standish Pl., 

Rockville, MD 20855, 301–827–3067, 

moeller@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The MUMS Animal Health Act 

became law on August 2, 2004 (Public 

Law 108–282). Several elements of the 

law became immediately effective on 

that date. These include the provisions 

for designation of MUMS drugs under 

section 573 and for conditional approval 

of MUMS drugs under section 571. The 

indexing provisions under section 572 

of the law will only become effective 

upon publication of final implementing 

regulations. As mandated by the MUMS 

law, FDA has established the new Office 

of MUMS Animal Drug Development in 

the Center for Veterinary Medicine 

(CVM). FDA is requesting comments on 

any aspect of implementation of the 

MUMS legislation (see section II of this 

document). Requests for further 

information should be directed to the 

Office of MUMS Animal Drug 

Development (see FOR FURTHER

INFORMATION CONTACT).

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments. 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. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday.

Dated: November 2, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24880 Filed 11–8–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0458]

Dietary Supplements; Strategy for the 

Further Implementation and 

Enforcement of the Dietary 

Supplement Health and Education Act 

of 1994; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of its strategy for the further 

implementation of the Dietary 

Supplement Health and Education Act 

of 1994 (DSHEA). The strategy sets forth 

a series of specific, integrated research 

and regulatory measures, including 

guidance, regulations, and sciencebased compliance and enforcement 

mechanisms. Through implementation 

of these measures, FDA hopes to 

improve the transparency, 

predictability, and consistency both of 

the agency’s scientific evaluations of 

dietary supplement product and 

ingredient safety, and of its regulatory 

actions to protect consumers against 

unsafe dietary supplements and dietary 

supplements making unauthorized, 

false, or misleading claims. FDA expects 

that this improved transparency will 

help engage stakeholders in the 

development of further measures to 

implement DSHEA.

DATES: Submit written or electronic 

comments at any time.

ADDRESSES: Submit written requests for 

single copies of the strategy for the 

further implementation of DSHEA to 

Vickey Lutwak, Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1775, FAX: 301–436–2636, email: Vickey.Lutwak@fda.gov.

Submit written comments 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:

Vickey Lutwak, Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1775, FAX: 301–436–2636, email: Vickey.Lutwak@fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In January 2000, FDA’s Center for 

Food Safety and Applied Nutrition 

(CFSAN) issued its ‘‘Dietary 

Supplement Strategy: Ten Year Plan’’

(the 10-year plan) (accessible at http://

www.cfsan.fda.gov/~dms/ds-strat.html). 

The 10-year plan sets as a goal a 

science-based regulatory program that 

fully implements DSHEA and affords 

consumers a high level of confidence in 

the safety, composition, and labeling of 

dietary supplement products. The 10-

year plan sets forth a series of critical 

initiatives: (1) Improving the safety of 

products through, for example, 

regulations on current good 

manufacturing practice requirements for 

dietary supplements, guidance on 

premarket safety notifications for new 

dietary ingredients, and better adverse 

event report monitoring; (2) improving 

the labeling of products by, for example, 

clarifying what data and information are 

needed to substantiate structure/

function and related claims in the 

labeling of a product; (3) clarifying the 

boundaries between dietary 

supplements, conventional foods, and 

drugs; (4) taking enforcement action 

against unsafe products and products 

whose labels are inaccurate or 

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:/