20024 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

1, 2011. A final rule regarding selected 

provisions of the IFR was published on 

December 7, 2011 (76 FR 76574, CMS– 

9998–FC) and an interim final rule 

regarding an issue not included in 

issuers’ reporting obligations 

(disbursement of rebates by non-federal 

governmental plans) was also published 

December 7, 2011 (76 FR 76596, CMS– 

9998–IFC2). Both rules published on 

December 7, 2011 are effective January 

1, 2012. Each issuer is required to 

submit annually MLR data, including 

information about any rebates it must 

provide, on a form prescribed by CMS, 

for each State in which the issuer 

conducts business. Each issuer is also 

required to provide a rebate notice to 

each enrollee that is due a rebate 

payment for any given MLR reporting 

year. Additionally, each issuer is 

required to maintain for a period of 

seven years all documents, records and 

other evidence that support the data 

included in each issuer’s annual report 

to the Secretary. 

The original 60-day comment period 

began on December 16, 2011 and 

pertained to the MLR Annual Reporting 

Form, and closed on February 14, 2012. 

On February 16, we published an 

amended PRA package with Notices to 

Consumers and reopened the public 

comment period until March 2, 2012 to 

accommodate comments on the 

amendments to the PRA package. We 

received a total of 15 public comments 

regarding the Annual Reporting Form 

and 11 public comments regarding the 

Notices to Consumers and Instructions 

for these notices. Most public comments 

addressed multiple issues. We have 

taken into consideration all the 

proposed suggestions and have made 

changes to the Annual Reporting Form 

and Instructions, as well as to the 

Notices to Consumers and Instructions. 

In addition, CMS is adjusting the 

estimated burden that correlates with 

the Rebate Notices and the MLR 

Information Notices. 

Form Number: CMS–10418 (OCN: 

0938–New); Frequency: Annual 

submission for each respondent; 

Affected Public: Private Sector: Business 

or other for-profits and not-for-profit 

institutions; Number of Respondents: 

527; Number of Responses: 5,530; Total 

Annual Hours: 352,563. (For policy 

questions regarding this collection, 

contact Carol Jimenez at (301) 492– 

4457. For all other issues, call (410) 

786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email 

your request, including your address, 

phone number, OMB number, and CMS 

document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on May 3, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: March 30, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–8080 Filed 4–2–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Study of Coordination of Tribal 

TANF and Child Welfare Services. 

OMB No.: New Collection. 

Description: The Study of 

Coordination of Tribal TANF and Child 

Welfare Services is sponsored by the 

Office of Planning, Research and 

Evaluation (OPRE), Administration for 

Children and Families of the U.S. 

Department of Health and Human 

Services. The study examines the 

approaches and strategies utilized by 

tribes and tribal organizations that were 

awarded the grants for Coordination of 

Tribal TANF and Child Welfare Services 

to Tribal Families at Risk of Child 

Abuse or Neglect. 

The descriptive study of these 

programs that serve tribal communities 

will document the way in which the 

tribal grantees are creating and adapting 

culturally relevant and appropriate 

approaches, systems, and programs to 

increase coordination and enhance 

service delivery to address child abuse 

and neglect. The study will also 

document challenges faced and lessons 

learned to inform the field of practice as 

well as policymakers and funders at 

various levels. 

The proposed information collection 

activities consist of semi-structured 

interviews, conducted at each of the 14 

tribal communities, and a grantee 

feedback survey on the usefulness of 

periodically held cross-grantee learning 

events. 

Respondents: Program director(s), 

tribal TANF and child welfare staff and 

supervisors, program partners, and 

tribal leaders or elders. The information 

collection does not include direct 

interaction with individuals or families 

that receive the services. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total annual 

burden hours 

Interview Protocol for Program Staff ............................................................. 9 3 1 .5 41 

Interview Protocol for TANF and CW Staff ................................................... 19 3 1 57 

Interview Protocol for Tribal or Community Partners .................................... 9 3 .75 20 

Interview Protocol for Tribal Leaders or Elders ............................................. 9 3 1 27 

Feedback Form for Community of Learning Events ..................................... 10 5 .15 8 

Estimated Total Annual Burden 

Hours: 153. 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

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Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 20025 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: OPRE Reports Clearance Officer. 

Email address: 

OPREinfocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

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. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–7923 Filed 4–2–12; 8:45 am] 

BILLING CODE 4184–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0508] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Blood Establishment Registration and 

Product Listing, Form FDA 2830 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Blood Establishment Registration and 

Product Listing, Form FDA 2830’’ 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 

January 4, 2012, the Agency submitted 

a proposed collection of information 

entitled ‘‘Blood Establishment 

Registration and Product Listing, Form 

FDA 2830’’ 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 0910–0052. 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: March 28, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7915 Filed 4–2–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0300] 

Draft Guidance for Industry on 

Compliance Policy for Reporting Drug 

Sample Distribution Information; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Compliance Policy on 

Reporting Drug Sample Distribution 

Information Under the Affordable Care 

Act.’’ This draft guidance is intended to 

provide information regarding the 

Agency’s implementation of the drug 

sample transparency reporting 

provisions of section 6004 of the Patient 

Protection and Affordable Care Act. The 

draft guidance notifies entities covered 

by the reporting obligations in section 

6004 that FDA does not intend to object 

until at least October 1, 2012, if 

manufacturers and authorized 

distributors of record (ADRs) do not 

submit information under those 

reporting provisions and that the 

Agency intends to provide notice before 

revising its exercise of discretion with 

respect to compliance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

electronic or written comments on the 

draft guidance by June 4, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002 or to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Donovan F. Duggan, Jr., Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4288, 

Silver Spring, MD 20993–0002, 301– 

796–0584; Paul Loebach, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4268, 

Silver Spring, MD 20993–0002, 301– 

796–2173; or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Compliance Policy on Reporting Drug 

Sample Distribution Information.’’ On 

March 23, 2010, the Affordable Care Act 

was signed into law. Among its many 

provisions, section 6004 of the 

Affordable Care Act amended the Social 

Security Act by adding section 1128H 

(42 U.S.C. 1320a–7i). This new section 

requires the submission of certain drug 

sample information to FDA not later 

than April 1 of each year, beginning 

April 1, 2012. 

The draft guidance is intended to 

provide information regarding the 

Agency’s implementation of section 

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