Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53257 

Part VI is a provision ‘‘sunsetting’’ the 

order after twenty (20) years, with 

certain exceptions. 

The purpose of the analysis is to 

facilitate public comment on the 

proposed order. It is not intended to 

constitute an official interpretation of 

the agreement and proposed order or to 

modify in any way their terms. 

By direction of the Commission. 

Donald S. Clark 

Secretary. 

[FR Doc. E9–24996 Filed 10–15–09; 9:30 am] 

BILLING CODE 6750–01–S 

GENERAL SERVICES 

ADMINISTRATION 

[OMB Control No. 3090–0228] 

Office of Civil Rights; Submission for 

OMB Review; Nondiscrimination in 

Federal Financial Assistance Programs 

AGENCY: Office of Civil Rights, GSA. 

ACTION: Notice of request for comments 

regarding a renewal to an existing OMB 

clearance. 

SUMMARY: Under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35), the General Services 

Administration will be submitting to the 

Office of Management and Budget 

(OMB) a request to review and approve 

a previously approved information 

collection requirement regarding 

nondiscrimination in Federal financial 

assistance programs. This information is 

needed to facilitate nondiscrimination 

in GSA’s Federal Financial Assistance 

Programs, consistent with Federal civil 

rights laws and regulations that apply to 

recipients of Federal financial 

assistance. 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary and whether it 

will have practical utility; whether our 

estimate of the public burden of this 

collection of information is accurate and 

based on valid assumptions and 

methodology; and ways to enhance the 

quality, utility, and clarity of the 

information to be collected. 

DATES: Submit comments on or before: 

November 16, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Sloan Farrell, Compliance Officer, 

Office of Civil Rights, at telephone (202) 

501–4347 or via e-mail to 

sloan.farrell@gsa.gov. 

ADDRESSES: Submit comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including suggestions for reducing this 

burden to the Regulatory Secretariat 

(MVPR), General Services 

Administration, 1800 F Street, NW., 

Room 4041, Washington, DC 20405. 

Please cite OMB Control No. 3090–0228, 

Nondiscrimination in Federal Financial 

Assistance Programs, in all 

correspondence. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The General Services Administration 

(GSA) has mission responsibilities 

related to monitoring and enforcing 

compliance with Federal civil rights 

laws and regulations that apply to 

Federal Financial Assistance programs 

administered by GSA. Specifically, 

those laws provide that no person on 

the ground of race, color, national 

origin, disability, sex or age shall be 

excluded from participation in, be 

denied the benefits of, or be otherwise 

subjected to discrimination under any 

program in connection with which 

Federal financial assistance is extended 

under laws administered in whole or in 

part by GSA. These mission 

responsibilities generate the 

requirement to request and obtain 

certain data from recipients of Federal 

surplus property for the purpose of 

determining compliance, such as the 

number of individuals, based on race 

and ethnic origin, of the recipient’s 

eligible and actual serviced population; 

race and national origin of those denied 

participation in the recipient’s 

program(s); non-English languages 

encountered by the recipient’s 

program(s) and how the recipient is 

addressing meaningful access for 

individuals that are Limited English 

Proficient; whether there has been 

complaints or lawsuits filed against the 

recipient based on prohibited 

discrimination and whether there has 

been any findings; and whether the 

recipient’s facilities are accessible to 

qualified individuals with disabilities. 

B. Annual Reporting Burden 

Respondents: 200. 

Responses per Respondent: 1. 

Total Responses: 200. 

Hours per Response: 2. 

Total Burden Hours: 400. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (MVPR), 1800 F 

Street, NW., Room 4041, Washington, 

DC 20405, telephone (202) 501–4755. 

Please cite OMB Control No. 3090–0228, 

Nondiscrimination in Federal Financial 

Assistance Programs, in all 

correspondence. 

Dated: October 8, 2009. 

Casey Coleman, 

Chief Information Officer. 

[FR Doc. E9–24879 Filed 10–15–09; 8:45 am] 

BILLING CODE 6820–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0475] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Detention and Banned Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection requirements for 

administrative detention and banned 

medical devices. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 15, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793, 

Denver.Presley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501-3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 


jlentini on DSKJ8SOYB1PROD with NOTICES
53258 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Administrative Detention and Banned 

Medical Devices (OMB Control Number 

0910–0114)—Extension 

FDA has the statutory authority under 

section 304(g) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

334(g)), to detain during established 

inspections, devices that are believed to 

be adulterated or misbranded. FDA 

issued a final rule that published in a 

March 9, 1979, Federal Register (44 FR 

13234) on administrative detention 

procedures, which includes among 

other things, certain reporting 

requirements and recordkeeping 

requirements under § 800.55(g) and (k), 

(21 CFR 800.55(g) and (k)). Under 

§ 800.55(g), an applicant of a detention 

order must show documentation of 

ownership if devices are detained at a 

place other than that of the appellant. 

Under § 800.55(k), the owner or other 

responsible person must supply records 

about how the devices may have 

become adulterated or misbranded, in 

addition to records of distribution of the 

detained devices. These recordkeeping 

requirements for administrative 

detentions pemits FDA to trace devices 

for which the detention period expired 

before a seizure is accomplished or 

injunctive relief is obtained. 

FDA also has the statutory authority 

under section 516 of the act (21 U.S.C. 

360f) to ban devices that present 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury. The final rule for 

banned devices that published in the 

May 18, 1979, Federal Register (44 FR 

29221) contained certain reporting 

requirements under 21 CFR 895.21(d) 

and 895.22(a). Section 895.21(d) states 

that if the Commissioner of Food and 

Drugs Administration (the 

Commissioner), decides to initiate a 

proceeding to make a device, ‘‘ a banned 

device,’’ a notice of proposed 

rulemaking will be published in the 

Federal Register and this document will 

contain the finding that the device 

presents a substantial deception or an 

unreasonable and substantial risk of 

illness or injury. The document will 

also contain the reasons why the 

proceeding was initiated, an evaluation 

of data and information obtained under 

other provisions of the act, any 

consultations with the panel, and a 

determination as to whether the device 

could be corrected by labeling, change 

of labeling, change of advertising, and if 

that labeling or change of advertising 

has been made. Under § 895.21(d), any 

interested person may request an 

informal hearing and submit written 

comments. Under § 895.22, a 

manufacturer, distributor, or importer of 

a device may be required to submit to 

FDA all relevant and available data and 

information to enable the Commissioner 

to determine whether the device 

presents substantial deception, 

unreasonable and substantial risk of 

illness or injury, or unreasonable, direct, 

and substantial danger to the health of 

individuals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

800.55(g) 1 1 1 25 25 

895.21(d) and 895.22(a) 26 1 26 16 416 

Totals 441 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

800.55(k) 1 1 1 20 20 

Totals 461 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

During the past several years, there 

has been an average of less than one 

new administrative detention action per 

year. Each administrative detention will 

have varying amounts of data and 

information that must be maintained. 

FDA’s estimate of the burden under the 

administrative detention provision is 

based on FDA’s discussion with one of 

three firms whose devices had been 

detained. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53259 

Dated: October 8, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24921 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Evaluation of the 

NIAID HIV Vaccine Research Education 

Initiative 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute of Allergy and Infectious 

Diseases (NIAID), 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 July 16, 2009, page 34580 

and allowed 60 days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: Evaluation 

of the NIAID HIV Vaccine Research 

Education Initiative. Type of 

Information Collection Request: NEW. 

Need and Use of Information Collection: 

To address the need for volunteers in 

HIV vaccine clinical trials, and enable 

NIAID to fulfill its Congressional 

mandate to prevent infectious diseases 

like HIV/AIDS, NIAID created the 

NIAID HIV Vaccine Research Education 

Initiative (NHVREI). The goal of 

NHVREI is to increase knowledge about 

and support for HIV vaccine research 

among U.S. populations most heavily 

affected by HIV/AIDS—in particular, 

African Americans, Hispanics/Latinos, 

men who have sex with men (MSM), 

women and youth, recognizing the 

intersection of these groups. 

NIAID is planning an evaluation of 

NHVREI to assess (a) implementation of 

NHVREI (i.e., process evaluation) and 

(b) impact (i.e., outcomes evaluation) of 

NHVREI on awareness of, knowledge 

about, and support for HIV vaccine 

research among NHVREI primary 

audiences (i.e., partner organizations, 

key influencers) that work with target 

populations. 

A survey will be conducted with key 

influencers of the NHVREI target 

populations to measure their level of 

awareness, knowledge about, and 

support for HIV vaccine research. Focus 

groups will also be conducted with 

representatives of organizations 

receiving grants through the NHVREI 

Local Partnership Program (LPP) and 

National Partnership Program (NPP), as 

well as representatives from a broader 

group of organizations called the 

NHVREI Network. The purpose of 

conducting focus groups with LPP, NPP, 

and NHVREI Network representatives is 

to obtain data on their experience 

implementing NHVREI activities. 

Questions asked during the group 

discussions will address efforts 

implementing educational activities and 

developing materials, community 

partnerships developed, engagement of 

key influencers in program activities, 

and the types of media outreach and 

capacity building engaged in. Frequency 

of Response: Twice. Affected Public: 

Individuals. Type of Respondents: Key 

influencers of target populations. The 

annual reporting burden is shown in the 

table below. There are no Capital Costs 

to report. There are no Operating or 

Maintenance Costs to report. 

Type of respondents Form name 

Estimated 

number of 

respondents 

No. of responses per 

respondent 

Average burden hours per 

response 

Estimated total 

annual burden 

hours 

requested 

Time 1 

LPP, NPP, and NHVREI Network .... Focus Groups ................................... 78 1 1 78 

Key Influencers ................................. Survey .............................................. 656 1 0.33 216 

Total Time 1 ..................................... 734 ........................ ........................ 294 

Time 2 

LPP, NPP, and NHVREI Network .... Focus Groups ................................... 78 1 1 78 

Key Influencers ................................. Survey .............................................. 590 1 0.33 195 

Total Time 2 ..................................... 668 ........................ ........................ 273 

Total Time 1 & Time 2 ..................... 1,402 ........................ ........................ 567 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact 

Katharine Kripke, Assistant Director, 

Vaccine Research Program, Division of 

AIDS, NIAID, NIH, 6700B Rockledge 

Dr., Bethesda, MD 20892–7628, or call 

non-toll-free number 301–402–0846, or 

E-mail your request, including your 

address to NIAIDSurvey@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 


jlentini on DSKJ8SOYB1PROD with NOTICES