21564 Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices 

Estimated Total Annual Burden 

Hours: 1,333.20. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–8512 Filed 4–9–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0306] 

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 for 

administrative detention and banned 

medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 11, 2012. 

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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@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 

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 FD&C Act) (21 

U.S.C. 334(g)) to detain during 

established inspections devices that are 

believed to be adulterated or 

misbranded. Section 800.55 (21 CFR 

800.55), on administrative detention, 

includes among other things, certain 

reporting requirements and 

recordkeeping requirements. 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 permit 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 FD&C Act (21 

U.S.C. 360f) to ban devices that present 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury. Section 895.21 (21 CFR 

895.21), on banned devices, contains 

certain reporting requirements. Section 

895.21(d) describes the procedures for 

banning a device when the 

Commissioner of Food and Drugs (the 

Commissioner) decides to initiate such 

a proceeding. Under 21 CFR 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. 

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. 

FDA estimates the burden of this 

collection of information as follows: 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices 21565 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

800.55(g) .......................................................... 1 1 1 25 25 

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

Total .......................................................... ............................ ............................ ............................ ............................ 441 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per 

recordkeeping 

Total hours 

800.55(k) .......................................................... 1 1 1 20 20 

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

Dated: April 3, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8507 Filed 4–9–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0439] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Food and Drug Administration Recall 

Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Food and Drug Administration Recall 

Regulations’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, ila.mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

November 28, 2011, the Agency 

submitted a proposed collection of 

information entitled ‘‘Food and Drug 

Administration Recall Regulations’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0249. The 

approval expires on March 31, 2015. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: April 3, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8514 Filed 4–9–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 77 FR 13613–13616 

dated March 7, 2012). 

This notice reflects organizational 

changes in the Health Resources and 

Services Administration. Specifically, 

this notice updates the functional 

statement for the HIV/AIDS Bureau 

(RV): (1) Rename the Division of Science 

and Policy (RVA) to the Division of 

Policy and Data (RVA) and update the 

functional statement; (2) rename the 

Office of Program Support (RV2) to the 

Office of Operations and Management 

(RV2); (3) rename the Division of 

Service Systems (RV5) to the Division of 

Metropolitan HIV/AIDS Programs (RV5) 

and update the function statement; (4) 

establish the Division of State HIV/AIDS 

Programs (RVD); (5) rename the Division 

of Community Based Programs (RV6) to 

the Division of Community HIV/AIDS 

Programs (RV6); and rename the 

Division of Training and Technical 

Assistance (RV7) to the Division of HIV/ 

AIDS Training and Capacity 

Development (RV7) and update the 

functional statement. 

Chapter RV—HIV/AIDS Bureau 

Section RV–10, Organization 

Delete in its entirety and replace with 

the following: 

The HIV/AIDS Bureau (RV) is headed 

by the Associate Administrator, HIV/ 

AIDS Bureau (HAB), who reports 

directly to the Administrator, Health 

Resources and Services Administration. 

HAB includes the following 

components: 

(1) Office of the Associate 

Administrator (RV); 

(2) Office of Operations and 

Management (RV2); 

(3) Division of Policy and Data (RVA); 

(4) Division of Metropolitan HIV/ 

AIDS Programs (RV5); 

(5) Division of State HIV/AIDS 

Programs (RVD); 

(6) Division of Community HIV/AIDS 

Programs (RV6); and 

(7) Division of HIV/AIDS Training 

and Capacity Development (RV7). 

Section RV–20, Functions 

(1) Delete the functional statement for 

the HIV/AIDS Bureau (RV) and replace 

in its entirety. 

Office of the Associate Administrator 

(RV) 

The Office of the Associate 

Administrator provides leadership and 

direction for the HIV/AIDS programs 

and activities of the Bureau and 


srobinson on DSK4SPTVN1PROD with NOTICES