Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 76473 

• Comments submitted in response to 

the November 2010 public hearing 

notice can be found at http:// 

www.regulations.gov using Docket No. 

FDA–2010–N–0477. 

• Additional information regarding 

implementation of the BPCI Act is 

available at: http://www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/UCM215031. 

IV. Notification of Intent To Participate 

in Consultation Meetings 

If you intend to participate in 

stakeholder consultation meetings 

regarding the development of 

recommendations for a user fee program 

for biosimilar and interchangeable 

biological product applications for FYs 

2013 through 2017, please provide 

notification by e-mail to BiosimilarsUser

FeeProgram@fda.hhs.gov by January 10, 

2011. Your e-mail should contain 

complete contact information, including 

name, title, affiliation, address, e-mail 

address, telephone number, and notice 

of any special accommodations required 

because of disability. Stakeholders will 

receive confirmation and additional 

information about the first meeting once 

FDA receives their notification. 

Dated: December 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30713 Filed 12–7–10; 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) Whether 

the proposed collection of information 

is necessary 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: Data Collection Tool 

for Rural Health Community-Based 

Grant Programs (OMB No. 0915– 

0319)—[Revision] 

On May 20, 2008, OMB approved the 

Agency’s request for the collection of 

data related to program and clinical 

measures (OMB No. 0915–0319) and set 

an expiration date of May 31, 2011. The 

Agency is now proceeding to submit a 

revised package which will include 

program specific measures that are 

further aligned with the agency’s 

updated clinical measures. These 

measures were modified based on the 

feedback received from grantees and to 

reflect ORHP and HRSA’s current 

priorities and clarify certain measures 

across all 330A programs. In addition, 

these revisions will enhance data 

collection and analysis in an effort to 

strengthen the value of the data 

collection tool. 

There are currently six rural health 

grant programs that operate under the 

authority of Section 301 of the Public 

Health Service (PHS) Act. These 

programs include: (1) Rural Health Care 

Services Outreach Grant Program 

(Outreach); (2) Rural Health Network 

Development Grant Program (Network 

Development); (3) Small Healthcare 

Provider Quality Grant Program 

(Quality); (4) Delta States Rural 

Development Network Grant Program 

(Delta); (5) Network Planning Grant 

Program and (6) Rural Health Workforce 

Development Grant Program. These 

grants are to provide for the expanded 

delivery of health care services, the 

planning and implementation of 

integrated health care networks, and the 

planning and implementation of quality 

improvement and workforce activities— 

all in rural areas. 

For these programs, performance 

measures were drafted to provide data 

useful to the programs and to enable 

HRSA to provide aggregate program data 

required by Congress under the 

Government Performance and Results 

Act (GPRA) of 1993. These measures 

cover the principal topic areas of 

interest to ORHP, including: (a) Access 

to care; (b) the underinsured and 

uninsured; (c) workforce recruitment 

and retention; (d) sustainability; (e) 

health information technology; (f) 

network development, and (g) health 

related clinical measures. Several 

measures will be used for all six 

programs. All measures will speak to 

the Office’s progress toward meeting the 

goals set. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Rural Health Care Services Outreach Grant Program .... 111 1 111 2 .75 305 .25 

Rural Health Network Development ................................ 49 1 49 2 98 

Delta States Rural Development Network Grant Program ............................................................................. 12 1 12 3 36 

Small Health Care Provider Quality Improvement Grant 

Program ........................................................................ 59 1 59 6 354 

Network Development Planning Grant Program ............. 30 1 30 1 30 

Rural Health Workforce Development Program .............. 20 1 20 1 .75 35 

Total .......................................................................... 281 ........................ 281 .......................... 858 .25 

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 60 days of 

this notice. 


jlentini on DSKJ8SOYB1PROD with NOTICES
76474 Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 

Dated: December 1, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–30894 Filed 12–7–10; 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 

Meeting 

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 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel. A Tolerance Approach to 

Xenotransplantation. 

Date: January 20, 2011. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817. 

Contact Person: Quirijn Vos, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIH/NIAID/DHHS, 6700B Rockledge Drive, 

MSC 7616, Bethesda, MD 20892. 301–451– 

2666. qvos@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: December 2, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–30811 Filed 12–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the National Advisory 

Eye 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 

Eye Council. 

Date: January 20, 2011. 

Open: 8:30 a.m. to 12 p.m. 

Agenda: Following opening remarks by the 

Director, NEI, there will be presentations by 

the staff of the Institute and discussions 

concerning Institute programs. 

Place: National Institutes of Health, 5635 

Fishers Lane, Terrace Level Conference 

Center, Bethesda, MD 20892. 

Closed: 1:15 p.m. to Adjournment. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Terrace Level Conference 

Center, Bethesda, MD 20892. 

Contact Person: Andrew P. Mariani, PhD, 

Executive Secretary, National Advisory Eye 

Council, National Eye Institute, National 

Institutes of Health. 301–451–2020. 

amp@nei.nih.gov. 

Any person interested 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 home page: http:// 

www.nei.nih.gov, where an agenda and any 

additional information will be posted when 

available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: December 2, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–30812 Filed 12–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel 

Developing Implementation Packages for 

Evidenced-based HIV Prevention 

Intervention Materials for Drug Users (5563). 

Date: December 14, 2010. 

Time: 9:30 a.m. to 12 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852. 

(Telephone Conference Call). 

Contact Person: Lyle Furr, Contract Review 

Specialist, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 220, MSC 8401, 6101 Executive 

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

435–1439. lf33c.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. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel Rapid 

Portable Devices to Measure Drug Use (1206). 

Date: December 20, 2010. 

Time: 9:30 a.m. to 12 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852. 

(Telephone Conference Call). 

Contact Person: Lyle Furr, Contract Review 

Specialist, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 220, MSC 8401, 6101 Executive 


jlentini on DSKJ8SOYB1PROD with NOTICES