Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 9029 

796–0700, e-mail: 

elizabeth.duvallmiller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

An important part of CDER’s 

commitment to make safe and effective 

drugs available to all Americans is 

optimizing the efficiency and quality of 

the drug review process. To support this 

primary goal, CDER has initiated 

various training and development 

programs to promote high performance 

in its regulatory project management 

staff. CDER seeks to significantly 

enhance review efficiency and review 

quality by providing the staff with a 

better understanding of the 

pharmaceutical industry and its 

operations. To this end, CDER is 

continuing its training program to give 

regulatory project managers the 

opportunity to tour pharmaceutical 

facilities. The goals are to provide the 

following: (1) Firsthand exposure to 

industry’s drug development processes 

and (2) a venue for sharing information 

about project management procedures 

(but not drug-specific information) with 

industry representatives. 

II. The Site Tours Program 

In this program, over a 2- to 3-day 

period, small groups (five or less) of 

regulatory project managers, including a 

senior level regulatory project manager, 

can observe operations of 

pharmaceutical manufacturing and/or 

packaging facilities, pathology/ 

toxicology laboratories, and regulatory 

affairs operations. Neither this tour nor 

any part of the program is intended as 

a mechanism to inspect, assess, judge, 

or perform a regulatory function, but is 

meant rather to improve mutual 

understanding and to provide an avenue 

for open dialogue. During the Site Tours 

Program, regulatory project managers 

will also participate in daily workshops 

with their industry counterparts, 

focusing on selective regulatory issues 

important to both CDER staff and 

industry. The primary objective of the 

daily workshops is to learn about the 

team approach to drug development, 

including drug discovery, preclinical 

evaluation, tracking mechanisms, and 

regulatory submission operations. The 

overall benefit to regulatory project 

managers will be exposure to project 

management, team techniques, and 

processes employed by the 

pharmaceutical industry. By 

participating in this program, the 

regulatory project manager will grow 

professionally by gaining a better 

understanding of industry processes and 

procedures. 

III. Site Selection 

All travel expenses associated with 

the site tours will be the responsibility 

of CDER; therefore, selection will be 

based on the availability of funds and 

resources for each fiscal year. Selection 

will also be based on firms having a 

favorable facility status as determined 

by FDA’s Office of Regulatory Affairs 

District Offices in the firms’ respective 

regions. Firms interested in offering a 

site tour or learning more about this 

training opportunity should respond by 

submitting a proposed agenda to Beth 

Duvall-Miller (see DATES and FOR

FURTHER INFORMATION CONTACT). 

Dated: February 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3461 Filed 2–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB), under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (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: Ryan White HIV/ 

AIDS Program Core Medical Services 

Waiver Application Requirements 

(OMB No. 0915–0307)—Extension 

Title XXVI, Section 2671 of the Public 

Health Service (PHS) Act, as amended 

by the Ryan White HIV/AIDS Treatment 

Extension Act of 2009 (Ryan White HIV/ 

AIDS Program), requires that grantees 

expend 75 percent of Parts A, B, and C 

Funds on core medical services, 

including antiretroviral drugs for 

individuals with HIV/AIDS, identified 

and eligible under the legislation. In 

order for Grantees under Parts A, B, and 

C to be exempted from the 75 percent 

core medical services requirement, they 

must request and receive a waiver from 

HRSA, as required in the Act. 

HRSA utilizes standards for granting 

waivers of the core medical services 

requirement for the Ryan White HIV/ 

AIDS Program. These standards meet 

the intent of the Ryan White HIV/AIDS 

Program to increase access to core 

medical services, including 

antiretroviral drugs for persons with 

HIV/AIDS, and to ensure that grantees 

receiving waivers demonstrate the 

availability of such services for 

individuals with HIV/AIDS, identified 

and eligible under Title XXVI of the 

PHS Act. The core medical services 

waiver uniform standard and waiver 

request process will apply to Ryan 

White HIV/AIDS Program Grant Awards 

under Parts A, B, and C of Title XXVI 

of the PHS Act. Core medical services 

waivers will be effective for a 1-year 

period that is consistent with the grant 

award period. 

Grantees must submit a waiver 

request with the annual grant 

application containing the certifications 

and documentation which will be 

utilized by HRSA in making 

determinations regarding waiver 

requests. Grantees must provide 

evidence that all of the core medical 

services listed in the statute, regardless 

of whether such services are funded by 

the Ryan White HIV/AIDS Program, are 

available to all individuals with HIV/ 

AIDS, identified and eligible under Title 

XXVI of the PHS Act in the service area 

within 30 days. 

The annual estimate of burden is as 

follows: 

mstockstill on DSKH9S0YB1PROD with NOTICES

9030 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 

Application Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Waiver Request ................................................................... 10 1 10 6.5 65 

Total .............................................................................. 10 1 10 6.5 65 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 30 days of 

this notice. 

Dated: February 10, 2011. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2011–3528 Filed 2–15–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Public Law 92–463), notice is hereby 

given of the following meeting: 

Name: Advisory Commission on 

Childhood Vaccines (ACCV). 

Date And Time: March 3, 2011, 9 a.m. 

to 5 p.m. EDT, March 4, 2011, 9 a.m. to 

12 p.m. EDT. 

Place: Parklawn Building (and via 

audio conference call), Conference 

Rooms G & H, 5600 Fishers Lane, 

Rockville, MD 20857. 

The ACCV will meet on Thursday, 

March 3 from 9 a.m. to 5 p.m. (EDT) and 

on Friday, March 4 from 9 a.m. to 12 

p.m. (EDT). The public can join the 

meeting via audio conference call by 

dialing 1–800–369–3104 on March 3 

and March 4 and providing the 

following information: 

Leader’s Name: Dr. Geoffrey Evans. 

Password: ACCV. 

Agenda: The agenda items for the 

March meeting will include, but are not 

limited to: updates from the Division of 

Vaccine Injury Compensation (DVIC), 

Department of Justice (DOJ), National 

Vaccine Program Office, Immunization 

Safety Office (Centers for Disease 

Control and Prevention), National 

Institute of Allergy and Infectious 

Diseases (National Institutes of Health), 

Center for Biologics, Evaluation and 

Research (Food and Drug 

Administration), a discussion on the 

VICP outreach efforts, and a review of 

Vaccine Information Statements (VISs). 

A draft agenda and additional meeting 

materials will be posted on the ACCV 

Web site (http://www.hrsa.gov/ 

vaccinecompensation/accv.htm) prior to 

the meeting. Agenda items are subject to 

change as priorities dictate. 

Public Comment: Persons interested 

in providing an oral presentation should 

submit a written request, along with a 

copy of their presentation to: Annie 

Herzog, DVIC, Healthcare Systems 

Bureau (HSB), Health Resources and 

Services Administration (HRSA), Room 

11C–26, 5600 Fishers Lane, Rockville, 

Maryland 20857 or e-mail: 

aherzog@hrsa.gov. Requests should 

contain the name, address, telephone 

number, e-mail address, and any 

business or professional affiliation of 

the person desiring to make an oral 

presentation. Groups having similar 

interests are requested to combine their 

comments and present them through a 

single representative. The allocation of 

time may be adjusted to accommodate 

the level of expressed interest. DVIC 

will notify each presenter by e-mail, 

mail or telephone of their assigned 

presentation time. Persons who do not 

file an advance request for a 

presentation, but desire to make an oral 

statement, may announce it at the time 

of the comment period. Public 

participation and ability to comment 

will be limited to space and time as it 

permits. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requiring information regarding 

the ACCV should contact Annie Herzog, 

DVIC, HSB, HRSA, Room 11C–26, 5600 

Fishers Lane, Rockville, MD 20857; 

telephone (301) 443–6593 or e-mail: 

aherzog@hrsa.gov. 

Dated: February 10, 2011. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2011–3527 Filed 2–15–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Ancillary Studies in 

Immunomodulation Clinical Trials (R01). 

Date: March 10, 2011. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: James T. Snyder, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities/ 

NIAID, National Institutes of Health, 6700B 

Rockledge Drive, MSC 7616, Room #3257, 

Bethesda, MD 20892–7616, 301–435–1614, 

james.snyder@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Genetics of Lupus. 

Date: March 11, 2011. 

Time: 11:30 a.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, 3136, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Wendy F. Davidson, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

DHHS/NIH/NIAID, 6700B Rockledge Drive, 

MSC 7616, Bethesda, MD 20892, 301–402– 

8399, davidsonw@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

mstockstill on DSKH9S0YB1PROD with NOTICES