60842 Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 

Dated: October 14, 2005. 

Karen V. Gregory, 

Assistant Secretary. 

[FR Doc. 05–20913 Filed 10–18–05; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meeting 

In accordance with section 10(d) of 

the Federal Advisory Committee Act (5 

U.S.C., Appendix 2), announcement is 

made of a Health Care Policy and 

Research Special Emphasis Panel (SEP) 

meeting. 

A Special Emphasis Panel is a group 

of experts in fields related to health care 

research who are invited by the Agency 

for Healthcare Research and quality 

(AHRQ), and agree to be available, to 

conduct on an as needed basis, 

scientific reviews of applications for 

AHRQ support. Individual members of 

the Panel do not attend regularly 

scheduled meetings and do not serve for 

fixed terms or a long period of time. 

Rather, they are asked to participate in 

particular review meetings which 

require their type of expertise. 

Substantial segments of the upcoming 

SEP meeting listed below will be closed 

to the public in accordance with the 

Federal Advisory Committee Act, 

section 10(d) of 5 U.S.C., Appendix 2 

and 5 U.S.C. 552b(c)(6). Grant 

applications for ‘‘The Centers for 

Education and Research on 

Therapeutics (CERTs),’’ are to be 

reviewed and discussed at this meeting. 

These discussions are likely to reveal 

personal information concerning 

individuals associated with the 

applications. This information is 

exempt from mandatory disclosure 

under the above-cited statutes. 

SEP Meeting on: The Centers for 

Education and Research on 

Therapeutics (CERTs). 

Date: November 2–3, 2005 (Open on 

November 2 from 8 a.m. to 8:15 a.m. and 

closed for the remainder of the meeting). 

Place: John M. Eisenberg Building, 

AHRQ Conference Center, 540 Gaither 

Road, Rockville, Maryland 20850. 

Contact Person: Anyone wishing to 

obtain a roster of members, agenda or 

minutes of the non-confidential portions 

of this meeting should contact Mrs. 

Bonnie Campbell, Committee 

Management Officer, Office of 

Extramural Research, Education and 

Priority Populations, AHRQ, 540 

Gaither Road, Room 2038, Rockville, 

Maryland 20850, Telephone (301) 427- 

1554. 

Agenda items for this meeting are 

subject to change as priorities dictate. 

Dated: October 07, 2005. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 05–20937 Filed 10–18–05; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003D–0367] 

Guidance for Industry on Providing 

Regulatory Submissions in Electronic 

Format—Human Pharmaceutical 

Product Applications and Related 

Submissions Using the Electronic 

Common Technical Document 

Specifications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format—

Human Pharmaceutical Product 

Applications and Related Submissions 

Using the eCTD Specifications.’’ This is 

one in a series of guidance documents 

on providing regulatory submissions to 

FDA in electronic format. This guidance 

discusses issues related to the electronic 

submission of new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), investigational new 

drug applications (INDs), master files, 

advertising material, and promotional 

labeling using the electronic common 

technical document (eCTD) 

specifications. The submission of these 

documents in electronic format should 

improve the agency’s efficiency in 

processing, archiving, and reviewing 

them. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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, or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. Submit written 

comments on the 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

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Randy Levin, Center for Drug Evaluation 

and Research (HFD–001), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

5411, e-mail: levinr@cder.fda.gov, or 

Robert Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Human 

Pharmaceutical Product Applications 

and Related Submissions Using the 

eCTD Specifications.’’ This document 

provides guidance to industry regarding 

submission of marketing applications 

(NDAs, ANDAs, BLAs), INDs, and 

related submissions (master files, 

advertising, and promotional labeling) 

in electronic format based on the 

International Conference on 

Harmonisation eCTD specifications. 

In the Federal Register of August 29, 

2003 (68 FR 52044), FDA made 

available a draft guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format—

Human Pharmaceutical Product 

Applications and Related Submissions’’

and gave interested persons an 

opportunity to submit comments by 

October 28, 2003. The agency 

considered received comments as it 

finalized this guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on providing 

applications and related submissions in 

electronic format. 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 

Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 60843 

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 guidance at any time. 

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 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. 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 collections of information in 

this guidance have been approved under 

OMB control number 0910–0014 (until 

January 31, 2006), OMB control number 

0910–0001 (until May 31, 2008), and 

OMB control number 0910–0338 (until 

September 30, 2008). 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

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

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

guidelines.htm, or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: October 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20921 Filed 10–18–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration will publish 

periodic summaries of proposed 

projects. To request more information 

on the proposed projects or to obtain a 

copy of the information collection 

plans, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are 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 estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Projects for 

Assistance in Transition From 

Homelessness (PATH) Program Annual 

Report (OMB No. 0930–0205)—Revision 

The Center for Mental Health Services 

awards grants each fiscal year to each of 

the States, the District of Columbia, the 

Commonwealth of Puerto Rico, the 

Virgin Islands, Guam, American Samoa, 

and the Commonwealth of the Northern 

Mariana Islands from allotments 

authorized under the PATH program 

established by Public Law 101–645, 42 

U.S.C. 290cc–21 et seq., the Stewart B. 

McKinney Homeless Assistance 

Amendments Act of 1990 (section 521 et 

seq. of the Public Health Service (PHS) 

Act). Section 522 of the PHS Act 

requires that the grantee States and 

Territories must expend their payments 

under the Act solely for making grants 

to political subdivisions of the State, 

and to non-profit private entities 

(including community-based veterans 

organizations and other community 

organizations) for the purpose of 

providing services specified in the Act. 

Available funding is allotted in 

accordance with the formula provision 

of section 524 of the PHS Act. 

This submission is for a revision of 

the current approval of the annual 

grantee reporting requirements. Section 

528 of the PHS Act specifies that not 

later than January 31 of each fiscal year, 

a funded entity will prepare and submit 

a report in such form and containing 

such information as is determined 

necessary for securing a record and 

description of the purposes for which 

amounts received under section 521 

were expended during the preceding 

fiscal year and of the recipients of such 

amounts and determining whether such 

amounts were expended in accordance 

with statutory provisions. 

The estimated annual burden for 

these reporting requirements is 

summarized in the table below. 

Respondents Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response 

(hrs.) 

Total burden 

States ............................................................................................................... 56 1 26 1,456 

Local provider agencies ................................................................................... 450 1 31 13,950 

Totals ........................................................................................................ 506 ........................ ........................ 15,406 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 71–1044, One Choke Cherry 

Road, Rockville, MD 20857. Written 

comments should be received within 60 

days of this notice. 

Dated: October 11, 2005. 

Anna Marsh, 

Director, Office of Program Services. 

[FR Doc. 05–20884 Filed 10–18–05; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2005–22721] 

Lower Mississippi River Waterway 

Safety Advisory Committee 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of meeting. 

SUMMARY: The Lower Mississippi River 

Waterway Safety Advisory Committee 

(LMRWSAC) will meet to discuss 

various issues relating to navigational 

safety on the Lower Mississippi River 

and related waterways. The meeting 

will be open to the public. 

DATES: The next meeting of LMRWSAC 

will be held on Tuesday, November 15, 

2005, from 9 a.m. to 12 p.m. This 

meeting may adjourn early if all 

business is finished. Requests to make