Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53235 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN—Continued 

PREA Provision Number of Respondents Number of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

505B(a)(3) Deferrals 54 3 .0 160 24 3,840 

505B(a)(4) Full and partial 

waivers 80 1 .4 110 8 880 

505B(e) Meetings 95 1 .7 160 16 2,560 

Total 12,580 

In addition, the draft guidance 

discusses when sponsors may need to 

report on the status of postmarketing 

study commitments as part of annual 

reports submitted under 21 CFR 

314.81(b) and 21 CFR 601.70. The 

burdens associated with the annual 

reporting requirements were previously 

accounted for under OMB number 

0910–0001 (expires 5/31/08) (for 21 CFR 

314.81(b) and OMB number 0910–0433 

(expires 3/31/07) (for 21 CFR 601.70). 

Furthermore, although labeling 

submissions are required under certain 

PREA provisions (e.g., section 

505B(a)(4)(D) of the act), the draft 

guidance does not provide 

recommendations on these requirements 

and therefore FDA has not estimated 

associated burdens. 

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: August 29, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17694 Filed 9–6–05; 8:45 am] 

BILLING CODE 4160–01–S 

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 

notify the Contact Person listed below 

in advance of the 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 Advisory 

Council on Drug Abuse. 

Date: September 21, 2005. 

Closed: 9 a.m. to 11:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Open: 1 p.m. to 4 p.m. 

Agenda: This portion of the meeting will 

be open to the public for announcements and 

reports of administrative, legislative and 

program developments in the drug abuse 

field. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Teresa Levitin, PhD, 

Director, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 220, MSC 8401, 6101 Executive 

Boulevard, Bethesda, MD 20892–8401, (301) 

433–2755. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their statement to 

the Contact Person listed on this notice. The 

statement should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. 

Information is also available on the 

Institute’s/Center’s Home page: http:// 

www.drugabuse.gov/NACDA/ 

NACDAHome.html, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse Research 

Programs, National Institutes of Health, HHS) 

Dated: August 29, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–17682 Filed 9–6–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

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 Heart, 

Lung, and Blood Institute Special 

Emphasis Panel, Review of Heart Study 

Applications (UO1s). 

Date: September 13, 2005. 

53236 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 

Time: 1:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

6701 Rockledge Drive, Bethesda, MD 

20892. (Telephone Conference Call). 

Contact Person: Valerie L. Prenger, 

PhD, Health Scientist Administrator, 

Review Branch, Room 7214, Division of 

Extramural Affairs, National Heart, 

Lung, and Blood Institute, 6701 

Rockledge Drive, MSC 7924, Bethesda, 

MD 20892–7924, (301) 435–0270, 

prengerv@nhlbi.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. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: August 29, 2005. 

Anthony M. Coelho, Jr., 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–17681 Filed 9–6–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; 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 Dental and 

Craniofacial Research Council. 

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. 

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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Dental and Craniofacial Research Council. 

Date: September 23, 2005. 

Open: 8:30 a.m. to 11:55 a.m. 

Agenda: Director’s Report, Implementation 

Plan Report, Concept Clearances. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference Rm. 

6C10, Bethesda, MD 20892. 

Closed: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference Rm. 

6C10, Bethesda, MD 20892. 

Contact Person: Norman S Braveman, PhD, 

Assistant to the Director, NIH–NIDCR, 

Building 31, Rm. 5B55, Bethesda, MD 20892, 

(301) 594–2089, Norman.Braveman@nih.gov. 

Any interested person may file 

written comments with the committee 

by forwarding the statement to the 

Contact Person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s hope page: http:// 

www.nidcr.hih.gov/about, where an 

agenda and any additional information 

for the meeting will be posted when 

available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: August 29, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–17680 Filed 9–6–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

Waiver of Compliance With Navigation 

and Inspection Laws 

AGENCY: Office of the Secretary, DHS. 

ACTION: Notice. 

Hurricane Katrina is one of the largest 

natural disasters to ever strike the 

United States. It has significantly 

disrupted production of oil and gas in 

the Gulf of Mexico, has caused many 

Gulf Coast oil refineries to go out of 

service because of flooding, lack of 

electric power or other reasons, and has 

significantly disrupted the pipeline 

transportation of oil and refined 

products from the Gulf Coast States. 

These production losses, outages and 

disruptions have already caused large 

runups in the price of oil, gasoline and 

other refined products. The Department 

of Homeland Security is also now 

receiving reports of threatened or actual 

shortages of gasoline, jet fuel, and other 

refined products, and of the rationing of 

these fuels, both in the Southeast U.S. 

and in other locations throughout the 

country. 

Numerous companies that produce 

and/or ship petroleum and/or refined 

petroleum products have submitted to 

the Department requests for waivers of 

the Merchant Marine Act of 1920 (the 

‘‘Jones Act’’ ). 46 U.S.C. App. section 1. 

This and related laws are generally 

referred to as the ‘‘coastwise laws.’’

These laws provide, among other things, 

that only vessels built and owned by 

citizens of the United States and flagged 

in the United States can carry 

merchandise between U.S. ports. 

The Secretary of Homeland Security 

is vested with the authority and 

discretion to waive the coastwise laws 

‘‘to such extent and in such manner and 

upon such terms as he may prescribe, 

either upon his own initiative or upon 

the written recommendation of the head 

of any other Government agency, 

whenever he deems that such action is 

necessary in the interest of national 

defense.’’ In consultation with and upon 

the recommendation of the Secretary of 

Energy, I have determined that such a 

waiver, in accordance with the terms set 

forth below, is in the interest of the 

national defense. 

The catastrophic destruction brought 

about by Hurricane Katrina has 

dramatically impeded, and in some 

places in the affected region stopped 

altogether, production and 

transportation or transmission of oil, 

refined petroleum products, natural gas, 

and electricity. Much of the lost oil 

production is from producing areas in 

the Gulf of Mexico which have been 

leased pursuant to programs of the 

Department of the Interior. This lost 

production, refining and transportation 

capacity has resulted in the threatened 

rationing and unavailability of gasoline, 

jet fuel and other refined products, and 

threatens the Nation’s economic and 

national security. I believe that waiver 

of the coastwise laws would facilitate 

the transportation of oil and refined 

petroleum products in and from 

portions of the United States devastated 

by the Hurricane, and to other regions 

affected by the disruptions that have 

occurred in the Gulf Coast area. 

Therefore, I am exercising my 

discretion and authority to waive the 

coastwise laws generally for the 

transportation of petroleum and refined