Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 75677 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New; 30-day 

notice] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed collection for public 

comment. Interested persons are invited 

to send comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–5683. Send written comments and 

recommendations for the proposed 

information collections within 30 days 

of this notice directly to the OS OMB 

Desk Officer; faxed to OMB at 202–395– 

5806. 

Proposed Project: Prevention and 

Wellness-Leveraging National 

Organizations- OMB No. 0990–NewOffice of Public Health and Science. 

Abstract: The Office of Public Health 

and Science is requesting an approval 

by OMB on a new collection. The 

American Recovery and Reinvestment 

Act (ARRA) Prevention and WellnessLeveraging National Organizations is a 

cooperative agreement program 

authorized under 42 U.S.C. 300k–1, 300, 

section 1701 of the Public Health 

Service Act, as amended. The funding 

opportunity focuses on two categories of 

activities: 

• Category A: Obesity prevention 

through improved nutrition and 

increased physical activity 

• Category B: Tobacco prevention and 

control 

The National Organizations who 

receive funding will be supporting 

Communities Putting Prevention to 

Work (CPPW)-funded communities by 

providing expertise and technical 

assistance to help implement select 

MAPPS (Media, Access, Point of 

Purchase/Promotion, Pricing, and Social 

Support and Services) strategies through 

national organizations’ systems and 

networks. The National Organizations 

will work to sustain community 

prevention efforts beyond Recovery Act 

CPPW funding and support the National 

Prevention Media Initiative through cobranding and augmenting HHSdeveloped media campaigns in 

communities. 

The outcome measures that will be 

collected from funded National 

Organizations include approval/ 

enactment of MAPPS-related policy, 

systems, and environmental change in 

physical activity, nutrition, and tobacco 

in funded communities. Since a critical 

component of the National 

Organizations is to support and assist 

CPPW-funded communities with their 

expert resources, the National 

Organizations and the CPPW-funded 

communities will share ownership of 

the same outcome measures. Because 

the National Organizations and their 

local affiliates have a distinct 

supporting role in these communitywide efforts, the output measures track 

the kinds of added-value to be derived 

from involvement of the National 

Organizations and its local affiliates in 

the community-wide efforts which 

should help drive the outcome measure. 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

(in hours) per 

response 

Total burden 

hours 

National Organizations Measures 

Instrument.

Cooperative Agreement recipients—National Organizations.10 4 2 80 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–30435 Filed 12–3–10; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0595] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Exports: 

Notification and Recordkeeping 

Requirements 

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 

the notification and recordkeeping 

requirements for persons exporting 

human drugs, biological products, 

devices, animal drugs, food, and 

cosmetics that may not be marketed or 

sold in the United States. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 4, 2011. 

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: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 


jdjones on DSK8KYBLC1PROD with NOTICES
75678 Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 

Administration, 1350 Piccard Dr., PI50– 

410B, Rockville, MD 20850, 301–796– 

3794, E-mail: 

Jonnalynn.Capezzuto@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. 

Exports: Notification and 

Recordkeeping Requirements—21 CFR 

Part 1 (OMB Control Number 0910– 

0482)—Extension 

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or marketed in the United States as 

allowed under section 801(e) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 381). In 

general, the notification identifies the 

product being exported (e.g., name, 

description, and in some cases, country 

of destination) and specifies where the 

notification should be sent. These 

notifications are sent only for an initial 

export; subsequent exports of the same 

product to the same destination (or, in 

the case of certain countries identified 

in section 802(b) of the FD&C Act (21 

U.S.C. 382)) would not result in a 

notification to FDA. 

The recordkeepers for this 

information collection export human 

drugs, biologics, devices, animal drugs, 

foods, and cosmetics that may not be 

sold in the United States and maintain 

records demonstrating their compliance 

with the requirements in section 

801(e)(1) of the FD&C Act. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency 

per response 

Total 

annual 

responses 

Hours per 

response Total hours 

1.101 (d) to (e) ..................................................................... 400 3 1,200 15 18,000 

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 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record 

Total 

hours 

1.101 (b) to (c) ........................................................... 320 3 960 22 21,120 

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

Dated: November 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30433 Filed 12–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–E–0032 and FDA– 

2010–E–0036] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; STELARA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

STELARA and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human biological 

product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 


jdjones on DSK8KYBLC1PROD with NOTICES