Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74061 

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30038 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0594] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Focus Groups as 

Used by the Food and Drug 

Administration (All Food and Drug 

Administration Regulated 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, 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 

focus groups as used by FDA to gauge 

public opinion on all FDA-regulated 

products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 31, 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 

Administration, 1350 Piccard Dr., PI50– 

400B, 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. 

Focus Groups as Used by the Food and 

Drug Administration (All FDARegulated Products)—(OMB Control 

Number 0910–0497)—Extension 

FDA conducts focus group interviews 

on a variety of topics involving FDAregulated products, including drugs, 

biologics, devices, food, tobacco, and 

veterinary medicine. 

Focus groups provide an important 

role in gathering information because 

they allow for a more indepth 

understanding of consumers’ attitudes, 

beliefs, motivations, and feelings than 

do quantitative studies. Focus groups 

serve the narrowly defined need for 

direct and informal opinion on a 

specific topic and as a qualitative 

research tool have three major purposes: 

• To obtain consumer information 

that is useful for developing variables 

and measures for quantitative studies, 

• To better understand consumers’ 

attitudes and emotions in response to 

topics and concepts, and 

• To further explore findings 

obtained from quantitative studies. 

FDA will use focus group findings to 

test and refine their ideas but will 

generally conduct further research 

before making important decisions, such 

as adopting new policies and allocating 

or redirecting significant resources to 

support these policies. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Focus Group Interviews ....................................................... 1,440 1 1,440 1.75 2,520 

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


jdjones on DSK8KYBLC1PROD with NOTICES
74062 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 

Annually, FDA projects about 20 

focus group studies using 160 focus 

groups with an average of 9 persons per 

group, and lasting an average of 1.75 

hours each. FDA is requesting this 

burden for unplanned focus groups so 

as not to restrict the Agency’s ability to 

gather information on public sentiment 

of its proposals in its regulatory and 

communications programs. 

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30037 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0588] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Exceptions or 

Alternatives to Labeling Requirements 

for Products Held by the Strategic 

National Stockpile 

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 information collection requirements 

for FDA regulations related to the 

exceptions or alternatives to labeling 

requirements for products held by the 

Strategic National Stockpile (SNS). 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 31, 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: 

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, 

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. 

Exceptions or Alternatives to Labeling 

Requirements for Products Held by the 

Strategic National Stockpile—(OMB 

Control Number 0910–0614)—Extension 

Under the Public Health Service Act 

(the PHS Act), the Department of Health 

and Human Services stockpiles medical 

products that are essential to the health 

security of the Nation (see section 319F– 

2 of the PHS Act (42 U.S.C. 247d-6b)). 

This collection of medical products for 

use during national health emergencies, 

known as the SNS, is to ‘‘provide for the 

emergency health security of the United 

States, including the emergency health 

security of children and other 

vulnerable populations, in the event of 

a bioterrorist attack or other public 

health emergency.’’ 

It may be appropriate for certain 

medical products that are or will be 

held in the SNS to be labeled in a 

manner that would not comply with 

certain FDA labeling regulations given 

their anticipated circumstances of use in 

an emergency. However, noncompliance 

with these labeling requirements could 

render such products misbranded under 

section 502 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 352). 

In the Federal Register of December 

28, 2007 (72 FR 73589), FDA published 

an interim final rule entitled 

‘‘Exceptions or Alternatives to Labeling 

Requirements for Products Held by the 

Strategic National Stockpile.’’ In the 

interim final rule, FDA issued 

regulations under §§ 201.26, 610.68, 

801.128, and 809.11 (21 CFR 201.26, 

610.68, 801.128, and 809.11), which 

allow the appropriate FDA Center 

Director to grant a request for an 

exception or alternative to certain 

regulatory provisions pertaining to the 

labeling of human drugs, biological 

products, medical devices, and in vitro 

diagnostics that currently are or will be 

included in the SNS if certain criteria 

are met. The appropriate FDA Center 

Director may grant an exception or 

alternative to certain FDA labeling 

requirements if compliance with these 

labeling requirements could adversely 

affect the safety, effectiveness, or 

availability of products that are or will 

be included in the SNS. An exception 

or alternative granted under the 

regulations may include conditions or 

safeguards so that the labeling for such 

products includes appropriate 

information necessary for the safe and 

effective use of the product given the 

product’s anticipated circumstances of 

use. Any grant of an exception or 

alternative will only apply to the 

specified lots, batches, or other units of 

medical products in the request. The 

appropriate FDA Center Director may 

also grant an exception or alternative to 

the labeling provisions specified in the 

regulations on his or her own initiative. 

Under § 201.26(b)(1)(i) (human drug 

products), § 610.68(b)(1)(i) (biological 

products), § 801.128(b)(1)(i) (medical 

devices), and § 809.11(b)(1)(i) (in vitro 

diagnostic products for human use) an 

SNS official or any entity that 

manufactures (including labeling, 

packing, relabeling, or repackaging), 

distributes, or stores such products that 

are or will be included in the SNS may 

submit, with written concurrence from 

a SNS official, a written request for an 

exception or alternative to certain 

labeling requirements to the appropriate 


jdjones on DSK8KYBLC1PROD with NOTICES