61492 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Type of Response No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Screener 6,700 1 6,700 0.10 670 

Telephone survey 1,500 1 1,500 0.25 375 

Internet panel survey 1,500 1 1,500 0.25 375 

Total 1,428 

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

These estimates are based on FDA’s 

and the contractor’s experience with 

previous surveys. Prior to administering 

the surveys with the entire sample, FDA 

plans to conduct pretests with up to 30 

adults; these are meant to evaluate the 

effectiveness of the programming of the 

interview protocol, online filters, and 

skip patterns. 

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25007 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0464] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Testing 

Communications on Biological 

Products 

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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

communication studies involving 

biological products, including vaccines 

and blood products, that are regulated 

by FDA. This information will be used 

to explore concepts of interest and assist 

in the development and modification of 

communication messages and 

campaigns to fulfill the Agency’s 

mission to protect the public health. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 6, 2010. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@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 

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. 

Testing Communications on Biological 

Products—New 

FDA is authorized by Section 

1003(d)(2)(D) of the Federal Food Drug 

and Cosmetic Act (21 U.S.C. Section 

393(d)(2)(D)) (Attachment 2) to conduct 

educational and public information 

programs relating to the safety of 

regulated biological products. FDA must 

conduct needed research to ensure that 

such programs have the highest 

likelihood of being effective. FDA 

expects that improving communications 

about biological products including 

vaccines and blood products will 

involve many research methods, 

including individual in-depth 

interviews, mall-intercept interviews, 

focus groups, self-administered surveys, 

gatekeeper reviews, and omnibus 

telephone surveys. 

The information collected will serve 

three major purposes. First, as formative 

research it will provide critical 

knowledge needed about target 

audiences to develop messages and 

campaigns about biological product use. 

Knowledge of consumer and healthcare 

professional decision-making processes 

will provide the better understanding of 

target audiences that FDA needs to 

design effective communication 

strategies, messages, and labels. These 

communications will aim to improve 

public understanding of the risks and 

benefits of using biological products 

including vaccines and blood products 

by providing users with a better context 

in which to place risk information more 

completely. 

Second, as initial testing, it will allow 

FDA to assess the potential effectiveness 

of messages and materials in reaching 

and successfully communicating with 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61493 

their intended audiences. Testing 

messages with a sample of the target 

audience will allow FDA to refine 

messages while still in the 

developmental stage. Respondents will 

be asked to give their reaction to the 

messages in either individual or group 

settings. 

Third, as evaluative research, it will 

allow FDA to ascertain the effectiveness 

of the messages and the distribution 

method of these messages in achieving 

the objectives of the message campaign. 

Evaluation of campaigns is a vital link 

in continuous improvement of 

communications at FDA. 

FDA estimates the burden of this 

collection of information based on 

recent prior experience with the various 

types of data collection methods 

described above: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

21 CFR 1003(d)(2)(D) 16,448 1 16,448 0.1739 2,860 

Total 16,448 1 16,448 0.1739 2,860 

1There are no capital costs associated with this collection of information. 

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25011 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0468] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Patent Term 

Restoration, Due Diligence Petitions, 

Filing, Format, and Content of 

Petitions 

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 

FDA’s patent term restoration 

regulations on due diligence petitions 

for regulatory review period revision. 

Where a patented product must receive 

FDA approval before marketing is 

permitted, the Office of Patents and 

Trademarks may add a portion of the 

FDA review time to the term of a patent. 

Petitioners may request reductions in 

the regulatory review time if FDA 

marketing approval was not pursued 

with ‘‘due diligence.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 6, 2010. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@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. 

Patent Term Restoration, Due Diligence 

Petitions, Filing, Format, and Content of 

Petitions—21 CFR Part 60 (OMB 

Control Number 0910–0233)—Extension 

FDA’s patent extension activities are 

conducted under the authority of the 

Drug Price Competition and Patent 

Term Restoration Act of 1984 (21 U.S.C. 

355(j)) and the Animal Drug and Patent 

Term Restoration Act of 1988 (35 U.S.C. 

156). New human drug, animal drug, 

human biological, medical device, food 

additive, or color additive products 

regulated by FDA must undergo FDA 

safety, or safety and effectiveness, 

review before marketing is permitted. 

Where the product is covered by a 

patent, part of the patent’s term may be 

consumed during this review, which 

diminishes the value of the patent. In 

enacting the Drug Price Competition 

and Patent Term Restoration Act of 1984 

and the Animal Drug and Patent Term 

Restoration Act of 1988, Congress 

sought to encourage development of 

new, safer, and more effective medical 

and food additive products. It did so by 

authorizing the U.S. Patent and 

Trademark Office (PTO) to extend the 

patent term by a portion of the time 

during which FDA’s safety and 

mstockstill on DSKH9S0YB1PROD with NOTICES