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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20026 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

6004. The draft guidance notifies 

entities covered by section 6004 that 

FDA does not intend to object until at 

least October 1, 2012, if manufacturers 

and ADRs do not submit information 

under section 6004 and that we intend 

to provide notice before revising our 

exercise of discretion with respect to 

compliance. The draft guidance also 

notifies covered entities that FDA plans 

to use its Electronic Submission 

Gateway (the Gateway) for submissions 

under section 6004 and that revisions to 

allow the Gateway to receive such 

submissions should be complete by 

April 1, 2012. Should covered entities 

wish to make such submissions 

notwithstanding FDA’s compliance 

policy, the draft guidance provides 

information about accessing the 

Gateway. The Agency expects to issue 

further draft guidance concerning the 

requirements of section 6004 later in 

2012. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent 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. 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. 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. 

III. Paperwork Reduction Act of 1995 

This draft guidance regarding Agency 

compliance policy refers to information 

collections under section 6004 that are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). As 

noted, the Agency is also preparing a 

draft guidance for release later this year 

to provide additional information 

regarding submissions under section 

6004. In accordance with the PRA, prior 

to publication of a final guidance 

document, FDA intends to solicit public 

comment and obtain OMB approval for 

any new information collections under 

section 6004. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, http://www.fda.gov/ 

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or http:// 

www.regulations.gov. 

Dated: March 28, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7912 Filed 3–29–12; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0071] 

Draft Guidance for Industry: Modified 

Risk Tobacco Product Applications; 

Availability; Agency Information 

Collection Activities; Proposed 

Collection; Comment Request 

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 ‘‘Modified Risk 

Tobacco Product Applications.’’ The 

draft guidance provides information 

about submitting applications for 

modified risk tobacco products under 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). The draft guidance 

describes the information that the FD&C 

Act requires you to submit in your 

modified risk tobacco product 

application and the scientific evidence 

FDA recommends you submit to 

support your application. The draft 

guidance also permits the filing of a 

single application for any modified risk 

tobacco product that is also a new 

tobacco product under the FD&C Act. 

DATES: Although you can submit written 

or electronic comments on this 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. Submit electronic or written 

comments on the proposed collection of 

information by June 4, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Modified Risk 

Tobacco Product Applications’’ to the 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a fax number to 

which the draft guidance may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance, including comments on 

the proposed collection of information, 

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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: Gail 

Schmerfeld or Kristin Davis, Center for 

Tobacco Products, 9200 Corporate 

Blvd., Rockville, MD 20850–3229, 1– 

877–287–1373, 

gail.schmerfeld@fda.hhs.gov or 

kristin.davis@fda.hhs.gov. 

With regard to the proposed collection 

of information: Daniel Gittleson, Office 

of Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–5156, 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (Pub. L. 111– 

31) (Tobacco Control Act) into law. The 

Tobacco Control Act grants FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect public health 

generally and to reduce tobacco use by 

minors. Congress found that it is 

essential that, prior to marketing 

tobacco products for use to reduce harm 

or the risk of tobacco-related disease or 

to reduce exposure to harmful 

substances associated with tobacco 

products, manufacturers be required to 

‘‘demonstrate that such products * * * 

meet a series of rigorous criteria, and 

will benefit the health of the population 

as a whole’’ (section 2(36) of the 

Tobacco Control Act). Thus, section 101 

of the Tobacco Control Act added 

section 911 (21 U.S.C. 387k) to the 

FD&C Act to prohibit the introduction 

or delivery for introduction into 

interstate commerce of any modified 

risk tobacco product unless an order 

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