73110 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

The guidance represents the Agency’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 requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 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 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively, and the collection of 

information under the guidance for 

industry ‘‘Special Protocol Assessment’’ 

has been approved under OMB control 

number 0910–0470. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen 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 document at either 

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

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: November 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29796 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Health Center Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of Noncompetitive 

Replacement Awards to Upper Room 

AIDS Ministry, Inc. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) will 

transfer Health Center Program (section 

330 of the Public Health Service Act) 

Increased Demand for Services (IDS) 

and Capital Improvement Project (CIP) 

funds, awarded under the American 

Recovery and Reinvestment Act 

(ARRA), originally awarded to Harlem 

United Community AIDS Center, Inc. 

(HUCAC) to Upper Room AIDS 

Ministry, Inc. to ensure the provision of 

critical primary health care services and 

continuity of services to low-income, 

underserved homeless patients in New 

York City. 

SUPPLEMENTARY INFORMATION: 

Former Grantee of Record: Harlem 

United Community AIDS Center, Inc. 

Original Period of Grant Support: 

March 27, 2009, to March 26, 2011 (IDS) 

and June 29, 2009, to June 28, 2011 

(CIP). 

Replacement Awardee: Upper Room 

AIDS Ministry, Inc. 

Amount of Replacement Award: 

$103,317 (IDS) and $262,740 (CIP). 

Period of Replacement Award: The 

period of support for the replacement 

awards is March 27, 2009 to March 26, 

2011 (IDS) and June 29, 2009 to June 28, 

2011 (CIP). 

Authority: Section 330(h) of the 

Public Health Service Act, 42 U.S.C. 

245b. 

CDFA Number: 93.703 

Justification for Exception to 

Competition: Under the original grant 

applications approved by HRSA, 

Harlem United Community AIDS 

Center, Inc. (HUCAC) was identified as 

the grantee of record. HUCAC had a 

subrecipient agreement in place with 

Upper Room AIDS Ministry, Inc., a 

HUCAC-subsidiary organization. 

Through this arrangement, Upper Room 

AIDS Ministry, Inc. provided all 

services and carried out the full scope 

of project for the homeless program. 

Instead of continuing this agreement, 

both organizations decided that Upper 

Room AIDS Ministry, Inc. should 

become the direct grantee recipient for 

the ARRA IDS and CIP grants. Upper 

Room AIDS Ministry, Inc. competed 

successfully for fiscal year 2010 Service 

Areas Competition funding and has 

become the direct grant recipient of the 

health center homeless grant. HUCAC 

and the Upper Room AIDS Ministry, 

Inc. requested that full responsibility for 

the grants be transferred from HUCAC to 

Upper Room AIDS Ministry. Upper 

Room AIDS Ministry has provided 

documentation to HRSA that it meets 

Section 330 statutory and regulatory 

requirements as well as applicable grant 

management requirements. 

The transfer of these grants will 

ensure critical primary health care 

services continue and remain available 

to low income, underserved homeless 

populations with no interruption in 

services to the target population. 

Transferring the funds to Upper Room 

AIDS Ministry, Inc. does not materially 

change the projects as originally 

proposed and funded. Upper Room 

AIDS Ministry, Inc. will fulfill the 

expectations of the former grantee’s 

originally funded IDS and CIP grant 

applications. In order to ensure that 

critical primary health care services 

continue to be available to the original 

target population in a timely manner, 

these ARRA CIP and IDS awards will 

not be competed. 

FOR FURTHER INFORMATION, CONTACT: 

Marquita Cullom-Stott via e-mail at 

MCullom-Stott@hrsa.gov or 301–594– 

4300. 

Dated: November 19, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–29866 Filed 11–26–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Part C Early Intervention Services 

Grant under the Ryan White HIV/AIDS 

Program 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of a non-competitive 

one-time replacement award from Ryan 

White HIV/AIDS Program, Part C funds 

for the Louisiana State University, 

Health Sciences Center, Viral Disease 

Clinic in Shreveport, Department of 

Medicine, Shreveport, Louisiana. 

SUMMARY: HRSA will be giving a noncompetitive one-time replacement 

award to support comprehensive 

primary care services for persons living 

with HIV/AIDS, including primary 

medical care, laboratory testing, oral 

health care, outpatient mental health 

and substance abuse treatment, 

specialty and subspecialty care, referrals 

for health and support services and 

adherence monitoring/education 

services to the Louisiana State 

University, Health Sciences Center, 

Viral Disease Clinic to ensure continuity 

of critical HIV medical care and 

treatment services, to clients in 

Shreveport, Louisiana. 

SUPPLEMENTARY INFORMATION: 

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Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73111 

Grantee of record: Premier Care and 

Learning Center, Shreveport, Louisiana. 

Intended recipient of the award: 

Louisiana State University, Health 

Sciences Center, Shreveport, Louisiana. 

Amount of the award: $268,377 to 

ensure ongoing clinical services to the 

target population. 

Authority: Section 2651 of the Public 

Health Service Act, 42 U.S.C. 300ff-51. 

CFDA Number: 93.918. 

Project period: July 1, 2010, to June 

30, 2011. The period of support for this 

non-competitive one-time replacement 

award is from July 1, 2010, to June 30, 

2011. 

Justification for the Exception to 

Competition 

Critical funding for HIV medical care 

and treatment services to clients in 

Shreveport, Louisiana, will be 

continued through a non-competitive 

replacement award to an existing grant 

award to the Louisiana State University, 

Health Sciences Center, Viral Disease 

Clinic. This is a non-competitive onetime replacement award because the 

previous grant recipient serving this 

population notified HRSA that it would 

not continue in the program after the 

fiscal year (FY) 2010 award was made. 

Louisiana State University, Health 

Sciences Center, Viral Disease Clinic is 

the best qualified grantee for this 

supplement, since it serves many of the 

former grantee’s patients and is the 

closest Part C Program to the former 

grantee. Further funding beyond 

June 30, 2011, for this service area 

will be competitively awarded during 

the Part C HIV Early Intervention 

Service competing application process 

for FY 2011. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Treat, by e-mail 

ktreat@hrsa.gov, or by phone, 301–443– 

7602. 

Dated: November 19, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–29865 Filed 11–26–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Customer and 

Other Partners Satisfaction Surveys 

SUMMARY: In compliance with the 

requirement of Section 3507(A)(1)(D) of 

the Paperwork Reduction Act of 1995 

for the opportunity for pubic comment 

on the proposed data collection projects, 

the Clinical Center (CC) of the National 

Institutes of Health, (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on September 21, 2010, pages 

57470–57472 and allowed 60 days for 

public comments. One comment 

regarding the use of government 

resources to conduct surveys was 

received during the 60-day comment 

period. The purpose of this notice is to 

provide an additional 30 days for public 

comment. 

5 CFR 1320.5 Respondents to this 

request for information collection 

should not respond unless the request 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: Generic 

Clearance for Satisfaction Surveys of 

Customer and Other Partners. Type of 

Information Collection Request: 

Extension (OMB Control Number: 0925– 

0458). Need and Use of Information 

Collection: The information collected in 

these surveys will be used by Clinical 

Center personnel: (1) To evaluate the 

satisfaction of various Clinical Center 

customers and other partners with 

Clinical Center services; (2) to assist 

with the design of modifications of 

these services, based on customer input; 

(3) to develop new services, based on 

customer need; and (4) to evaluate the 

satisfaction of various Clinical Center 

customers and other partners with 

implemented service modifications. 

These surveys will almost certainly lead 

to quality improvement activities that 

will enhance and/or streamline the 

Clinical Center’s operations. The major 

mechanisms by which the Clinical 

Center will request customer input is 

through surveys and focus groups. The 

surveys will be tailored specifically to 

each class of customer and to that class 

of customer’s needs. Surveys will either 

be collected as written documents, as 

faxed documents, mailed electronically 

or collected by telephone from 

customers. Information gathered from 

these surveys of Clinical Center 

customers and other partners will be 

presented to, and used directly by, 

Clinical Center management to enhance 

the services and operations of our 

organization. Frequency of Response: 

The participants will respond yearly. 

Affected Public: Individuals and 

households, businesses and other for 

profit, small businesses and 

organizations. Types of Respondents: 

These surveys are designed to assess the 

satisfaction of the Clinical Center’s 

major internal and external customers 

with the services provided. These 

customers include, but are not limited 

to, the following groups of individuals: 

Clinical Center patients, family 

members of Clinical Center patients, 

visitors to the Clinical Center, NIH 

intramural collaborators, private 

physicians or organizations who refer 

patients to the Clinical Center, 

volunteers, vendors and collaborating 

commercial enterprises, small 

businesses, regulators, and other 

organizations. The annual reporting 

burden is as follows: 

Customer Number of respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

FY 2010 

Clinical Center Patients ................................................................................. 5000 1 .5 2500 

Family Members of Patients .......................................................................... 2000 1 .5 1000 

Visitors to the Clinical Center ........................................................................ 1000 1 .17 170 

NIH Intramural Collaborators ......................................................................... 2000 1 .17 340 

Vendors and Collaborating Commercial Enterprises .................................... 2500 1 .33 833 

Professionals and Organizations Referring Patients ..................................... 2000 1 .33 833 

Regulators ...................................................................................................... 30 1 .33 10 

Volunteers ...................................................................................................... 275 1 .5 138 

Total ........................................................................................................ 14,805 ........................ .......................... 5,824 

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