Federal Register / Vol. 70, No. 162 / Tuesday, August 23, 2005 / Notices 49297 

adequate consideration in preparation of 

the final guidance. 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single copies of the draft guidance to the 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, 1401 Rockville Pike, 

suite 200N, 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 The draft guidance may also be 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 CBER 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: 

Brenda R. Friend, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Gene Therapy Clinical 

Trials—Observing Participants for 

Delayed Adverse Events’’ dated August 

2005. This draft guidance provides to 

sponsors of gene therapy studies 

recommendations on: (1) Methods to 

assess the risk of gene-therapy-related 

delayed adverse events following 

exposure to gene therapy products, (2) 

guidance for determining the likelihood 

that long-term followup observations on 

study participants will provide 

scientifically meaningful information, 

and (3) specific advice regarding the 

duration and design of long-term 

followup observations. 

This draft guidance, when finalized, 

will supplement the recommendations 

in the ‘‘Guidance for Industry: 

Supplemental Guidance on Testing for 

Replication Competent Retrovirus in 

Retroviral Vector Based Gene Therapy 

Products and During Follow-up of 

Patients in Clinical Trials Using 

Retroviral Vectors’’ (Retroviral Vector 

guidance), dated October 2000, for study 

participant long-term followup. 

However, the recommendations in the 

Retroviral Vector guidance regarding the 

length of followup will be superseded 

by this Gene Therapy Clinical Trials 

guidance. 

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 FDA’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. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The information collection 

provisions in this guidance for the 

investigational new drug application 

(IND) regulations (21 CFR part 312) have 

been approved under OMB control 

number 0910–0014; and the good 

laboratory practice (GLP) regulations (21 

CFR part 58) have been approved under 

OMB control number 0910–0119. 

III. Comments 

The draft guidance 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 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 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

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

default.htm. 

Dated: August 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–16629 Filed 8–22–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Proposed Collection; Comment 

Request; Prior Disclosure Regulations 

AGENCY: Bureau of Customs and Border 

Protection (CBP), U.S. Department of 

Homeland Security (DHS). 

ACTION: Notice and request for 

comments. 

SUMMARY: The Department of the 

Homeland Security, as part of its 

continuing effort to reduce paperwork 

and respondent burden, CBP invites the 

general public and other Federal 

agencies to comment on an information 

collection requirement concerning the 

Prior Disclosure Regulations. This 

proposed information collection was 

previously published in the Federal 

Register (70 FR 35280–35281) on June 

17, 2005, allowing for a 60-day 

comment period. This notice allows for 

an additional 30 days for public 

comments. This request for comment is 

being made pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3506(c)(2)(A)). 

DATES: Written comments should be 

received on or before September 22, 

2005, to be assured of consideration. 

ADDRESSES: Direct all written comments 

to the Bureau of Customs and Border 

Protection, Information Services Branch 

Attn.: Tracey Denning, 1300 

Pennsylvania Avenue NW., Room 3.2C, 

Washington, DC 20229. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to U.S. Customs 

Service, Attn.: Tracey Denning, 1300 

Pennsylvania Avenue NW., Room 3.2C, 

Washington, DC 20229, Tel. (202) 344–

1429. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3506(c)(2)(A)). The comments 

should address the accuracy of the 

burden estimates and ways to minimize 

the burden including the use of 

automated collection techniques or the 

use of other forms of information 

technology, as well as other relevant 

aspects of the information collection. 

The comments that are submitted will 

be summarized and included in the CBP 

request for Office of Management and 

Budget (OMB) approval. All comments 

will become a matter of public record. 

In this document CBP is soliciting 

49298 Federal Register / Vol. 70, No. 162 / Tuesday, August 23, 2005 / Notices 

comments concerning the following 

information collection: 

Title: Prior Disclosure Regulations. 

OMB Number: 1651–0074. 

Form Number: N/A. 

Abstract: This collection of 

information is required to implement a 

provision of the Customs Modernization 

portion of the North American Free 

Trade Implementation Act concerning 

prior disclosure by a person of a 

violation of law committed by that 

person involving the entry or 

introduction or attempted entry or 

introduction of merchandise into the 

United States by fraud, gross negligence 

or negligence, pursuant to 19 U.S.C. 

1592(c)(4), as amended. 

Current Actions: There are no changes 

to the information collection. This 

submission is being submitted to extend 

the expiration date. 

Type of Review: Extension (without 

change). 

Affected Public: Business or other forprofit institutions. 

Estimated Number of Respondents: 

3,500. 

Estimated Time per Respondent: 60 

minutes. 

Estimated Total Annual Burden 

Hours: 3,500. 

Estimated Annualized Cost to the 

Public: N/A. 

Dated: August 16, 2005. 

Tracey Denning, 

Agency Clearance Officer, Information 

Services Branch. 

[FR Doc. 05–16719 Filed 8–22–05; 8:45 am] 

BILLING CODE 9110–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Proposed Collection; Comment 

Request Vessel Entrance or Clearance 

Statement Form 

AGENCY: Bureau of Customs and Border 

Protection (CBP), Department of 

Homeland Security (DHS). 

ACTION: Notice and request for 

comments. 

SUMMARY: The Department of Homeland 

Security, as part of its continuing effort 

to reduce paperwork and respondent 

burden, CBP invites the general public 

and other Federal agencies to comment 

on an information collection 

requirement concerning Vessel Entrance 

of Clearance Statement. This proposed 

information collection was previously 

published in the Federal Register (70 

FR 35280–35281) on June 17, 2005, 

allowing for a 60-day comment period. 

This notice allows for an additional 30 

days for public comments. This request 

for comment is being made pursuant to 

the Paperwork Reduction Act of 1995 

(Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). 

DATES: Written comments should be 

received on or before September 22, 

2005, to be assured of consideration. 

ADDRESSES: Direct all written comments 

to Customs and Border Protection, 

Information Services Group, Attn.: 

Tracey Denning, 1300 Pennsylvania 

Avenue, NW., Room 3.2C, Washington, 

DC 20229. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to U.S. Customs 

Service, Attn.: Tracey Denning, 1300 

Pennsylvania Avenue, NW., Room 3.2C, 

Washington, DC 20229, Tel. (202) 344–

1429. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). The comments 

should address: (1) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimates of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden including 

the use of automated collection 

techniques or the use of other forms of 

information technology; and (e) 

estimates of capital or start-up costs and 

costs of operations, maintenance, and 

purchase of services to provide 

information. The comments that are 

submitted will be summarized and 

included in the CBP request for Office 

of Management and Budget (OMB) 

approval. All comments will become a 

matter of public record. In this 

document CBP is soliciting comments 

concerning the following information 

collection: 

Title: Vessel Entrance or Clearance 

Statement Form. 

OMB Number: 1651–0019. 

Form Number: CBP Form 1300. 

Abstract: This form is used by a 

master of a vessel to attest to the 

truthfulness of all other forms 

associated with the manifest. 

Current Actions: There are no changes 

to the information collection. This 

submission is being submitted to extend 

the expiration date. 

Type of Review: Extension (without 

change). 

Affected Public: Businesses, 

Individuals, Institutions. 

Estimated Number of Respondents: 

12,000. 

Estimated Time per Respondent: 5 

minutes. 

Estimated Total Annual Burden 

Hours: 21,991. 

Estimated Total Annualized Cost on 

the Public: N/A. 

Dated: August 16, 2005. 

Tracey Denning, 

Agency Clearance Officer, Information 

Services Group. 

[FR Doc. 05–16723 Filed 8–22–05; 8:45 am] 

BILLING CODE 9110–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Agency Information Collection 

Activities: Entry and Manifest of 

Merchandise Free of Duty 

AGENCY: Bureau of Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Proposed collection; comments 

requested. 

SUMMARY: The Bureau of Customs and 

Border Protection (CBP) of the 

Department of Homeland Security has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and approval in accordance with 

the Paperwork Reduction Act of 1995: 

Entry and Manifest of Merchandise Free 

of Duty. This is a proposed extension of 

an information collection that was 

previously approved. CBP is proposing 

that this information collection be 

extended with no change to the burden 

hours. This document is published to 

obtain comments from the public and 

affected agencies. This proposed 

information collection was previously 

published in the Federal Register (70 

FR 35284) on June 17, 2005, allowing 

for a 60-day comment period. This 

notice allows for an additional 30 days 

for public comments. This process is 

conducted in accordance with 5 CFR 

1320.10. 

DATES: Written comments should be 

received on or before September 22, 

2005. 

ADDRESSES: Written comments and/or 

suggestions regarding the items 

contained in this notice, especially the 

estimated public burden and associated