930 Federal Register / Vol. 69, No. 4 / Wednesday, January 7, 2004 / Notices 

agency’s current thinking on these 

topics. 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comments on the draft guidance .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 The draft guidance and 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 30, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–259 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2002N–0276 and 2002N–0278]

Small Entity Compliance Guides on 

Registration of Food Facilities and 

Prior Notice of Imported Food; 

Correction.

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document that appeared in the Federal 

Register of December 12, 2003 (68 FR 

69408). This document is being 

republished in its entirety and will read 

as follows: The Food and Drug 

Administration (FDA) is announcing the 

availability of small entity compliance 

guides (SECGs) for the interim final 

rules on Registration of Food Facilities 

and Prior Notice of Imported Food 

issued under the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act). Both interim final rules published 

in the Federal Register of October 10, 

2003. These SECGs are intended to help 

small businesses better understand the 

registration and prior notice regulations.

DATES: Submit written or electronic 

comments on the SECGs at any time.

ADDRESSES: Submit written comments 

concerning these SECGs to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. Submit electronic comments on 

the SECGs to http://www.fda.gov/

dockets/ecomments.

Submit requests for single copies of 

one or both SECGs to the Prior Notice 

help desk by telephone at 1–800–216–

7331 (within the United States) or 301–

575–0156 (outside the United States), by 

FAX: 301–210–0247, or by e-mail: 

furls@fda.gov. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to these SECGs.

FOR FURTHER INFORMATION CONTACT:

Questions Concerning Registration: 

Nina Adler, Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–0417, FAX 301–827–

0482; or Judith Gushee, Center for Food 

Safety and Applied Nutrition (HFS–

605), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD, 20740, 301–436–2417.

Questions Concerning Prior Notice: 

Deborah Ralston, Office of Regulatory 

Affairs, Office of Regional Operations 

(HFC–100), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–443–6230.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 10, 

2003 (68 FR 58894 and 68 FR 58974), 

FDA issued two interim final rules to 

implement sections 305 (Registration of 

Food Facilities) and 307 (Prior Notice of 

Imported Food) of the Bioterrorism Act. 

The registration interim final rule 

requires domestic and foreign facilities 

that manufacture/process, pack, or hold 

food for human or animal consumption 

in the United States to register with 

FDA by December 12, 2003. The prior 

notice interim final rule requires the 

submission to FDA of prior notice of 

food, including animal feed, that is 

imported or offered for import into the 

United States beginning on December 

12, 2003.

We examined the economic 

implications of these interim rules as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612) and determined 

that they would have a significant 

economic impact on a substantial 

number of small entities.

In compliance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (Public Law 104–121), we 

are making available these SECGs that 

explain the requirements of these 

regulations.

FDA is issuing these SECGs as level 

2 guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(c)(2)). These SECGs restate, in 

simplified format and language, FDA’s 

current requirements for Registration of 

Food Facilities and Prior Notice of 

Imported Food. As guidance, these 

documents are not binding on either 

FDA or the public. FDA notes, however, 

that the regulations that serve as the 

basis for these guidance documents 

establish requirements for all covered 

activities. For this reason, FDA strongly 

recommends that affected parties 

consult the regulations at 21 CFR part 1, 

subparts H and I, in addition to reading 

these SECGs.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding these SECGs. 

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 

applicable docket number(s) 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.

III. Electronic Access

Persons with access to the Internet 

may obtain these SECGs at http://www/

cfsan.fda.gov/guidance.html.

Dated: December 29, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–257 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

Secretary’s Advisory Committee on 

Xenotransplantation (SACX). 

Federal Register / Vol. 69, No. 4 / Wednesday, January 7, 2004 / Notices 931

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting.

Name of Committee: Secretary’s Advisory 

Committee on Xenotransplantation. 

Date: February 24, 2004. 

Open: February 24, 2004; 8 a.m. to 5:30 

p.m. 

Agenda: The SACX will focus on a variety 

of issues relating to the science and ethics of 

xenotransplantation. A significant portion of 

the meeting will be devoted to discussion of 

two draft reports by the SACX. These draft 

reports address the state of the science in 

xenotransplantation and informed consent 

issues in xenotransplantation. Additional 

presentations and discussion will focus on 

recent advances in xenotransplantation 

research, including a report of a clinical 

study of porcine islet xenotransplantation in 

type 1 diabetic patients. 

Place: Holiday Inn Select, 8120 Wisconsin 

Avenue, Bethesda, MD 20814. 

Pre-Registration: The SACX meeting is 

open to the public; however, seating is 

limited and pre-registration is encouraged. 

To register, please contact Capital Consulting 

Corporation (Terry Fisher) at 301–468–6004, 

extension 434. Individuals who plan to 

attend the meeting and who need special 

assistance or other reasonable 

accommodations should notify Ms. Fisher 

prior to the meeting. 

Public Comment: Individuals who wish to 

provide public comment (oral or written) 

should contact the SACX Executive Director, 

Dr. Mary Groesch, by telephone at 301–496–

0785 or e-mail at groeschm@od.nih.gov. 

Contact Person: Mary Groesch, Ph.D., 

Executive Director, Secretary’s Advisory 

Committee on Xenotransplantation, Office of 

Science Policy, Rockledge I, Room 750, 

Bethesda, MD 20892, 301–496–9838. 

Information is also available on the Office’s 

home page: http://www4.od.nih.gov/oba/

Sacx.htm, where an agenda and any 

additional information for the meeting will 

be posted when available.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds; 93.22, Clinical 

Research Loan Repayment Program for 

Individuals from Disadvantaged 

Backgrounds; 93.232, Loan Repayment 

Program for Research Generally; 93.39, 

Academic Research Enhancement Award; 

93.936, NIH Acquired Immunodeficiency 

Syndrome Research Loan Repayment 

Program, National Institutes of Health, HHS)

Dated: December 31, 2003. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–255 Filed 1–6–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Special Emphasis Panel, Immune 

Escape in Human Cancer: Mechanisms and 

Therapeutic Implications. 

Date: January 19–21, 2004. 

Time: 7 p.m. to 11 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard By Marriott Shadyside/

Oakland, 5308 Liberty Avenue, Pittsburgh, 

PA 15224. 

Contact Person: Shakeel Ahmad, Ph.D., 

Scientific Review Administrator, Research 

Programs Review Branch, National Cancer 

Institute, Division of Extramural Activities, 

6116 Executive Blvd., Bethesda, MD 20892, 

(301) 594–0114, amads@mail.nih.gov.

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS).

Dated: December 30, 2003. 

Anna P. Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–253 Filed 1–6–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: Center for Inherited 

Disease Research Access Committee. 

Date: January 8, 2004. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites, Washington, DC. 

Contact Person: Rudy O. Pozzatti, PhD., 

Scientific Review Administrator. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS)

Dated: December 31, 2003. 

Anna P. Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–254 Filed 1–6–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. appendix 2), notice 

is hereby given of a meeting of the 

National Advisory Council on Drug 

Abuse. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should