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
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74063 

FDA Center Director. Except when 

initiated by an FDA Center Director, a 

request for an exception or alternative 

must be in writing and must: 

• Identify the specified lots, batches, 

or other units of the affected product; 

• Identify the specific labeling 

provisions under this rule that are the 

subject of the request; 

• Explain why compliance with the 

specified labeling provisions could 

adversely affect the safety, effectiveness, 

or availability of the product subject to 

the request; 

• Describe any proposed safeguards 

or conditions that will be implemented 

so that the labeling of the product 

includes appropriate information 

necessary for the safe and effective use 

of the product given the anticipated 

circumstances of use of the product; 

• Provide copies of the proposed 

labeling of the specified lots, batches, or 

other units of the affected product that 

will be subject to the exception or 

alternative; and 

• Provide any other information 

requested by the FDA Center Director in 

support of the request. 

If the request is granted, the 

manufacturer may need to report to FDA 

any resulting changes to the New Drug 

Application, Biologics License 

Application, Premarket Approval 

Application or Premarket Notification 

(510(k)) in effect, if any. The submission 

and grant of an exception or an 

alternative to the labeling requirements 

specified in the interim final rule (72 FR 

73589) may be used to satisfy certain 

reporting obligations relating to changes 

to product applications under § 314.70 

(21 CFR 314.70) (human drugs), § 601.12 

(21 CFR 601.12) (biological products), 

§ 814.39 (21 CFR 814.39) (medical 

devices subject to premarket approval), 

or § 807.81 (21 CFR 807.81) (medical 

devices subject to 510(k) clearance 

requirements). The information 

collection provisions in §§ 314.70, 

601.12, 807.81, and 814.39 have been 

approved under OMB control numbers 

0910–0001, 0910–0338, 0910–0120, and 

0910–0231, respectively. On a case-bycase basis, the appropriate FDA Center 

Director may also determine when an 

exception or alternative is granted that 

certain safeguards and conditions are 

appropriate, such as additional labeling 

on the SNS products, so that the 

labeling of such products would include 

information needed for safe and 

effective use under the anticipated 

circumstances of use. 

Respondents to this collection of 

information are entities that 

manufacture (including labeling, 

packing, relabeling, or repackaging), 

distribute or store affected SNS 

products. Based on the number of 

requests for an exception or alternative 

received by FDA since issuance of the 

interim final rule, FDA estimates an 

average of two requests annually. FDA 

is estimating that each respondent will 

spend an average of 24 hours preparing 

each request. The hours per response for 

each submission are based on the 

estimated time that it takes to prepare a 

supplement to an application, which 

may be considered similar to a request 

for an exception or alternative. To the 

extent that labeling changes not already 

required by FDA regulations are made 

in connection with an exception or 

alternative granted under the interim 

final rule, FDA is estimating one 

occurrence annually in the event FDA 

would require any additional labeling 

changes not already covered by FDA 

regulations, and that it would take 8 

hours to develop and revise the labeling 

to make such changes. 

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 

201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and 

809.11(b)(1)(i) ................................................................... 2 1 2 24 48 

201.26(b)(1)(i), 610.68(b)(1)(i), ............................................

801.128(b)(1)(i), and 809.11(b)(1)(i) .................................... 1 1 1 8 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 56 

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

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30036 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–0576] 

Supplemental Funding Under the Food 

and Drug Administration’s Convener of 

Active Medical Product Surveillance 

Discussions (U13) RFA–FD–09–012; 

Request for Supplemental Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of intent. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

program expansion of its Conference 

Cooperative Agreement Program (U13), 

awarded to the Engelberg Center for 

Health Care Reform at the Brookings 

Institution (Brookings). The goal of this 

expansion is to plan and hold meetings 

and conferences that will ensure broad 

stakeholder input on FDA programs and 

initiatives related to disseminating 

information from active medical 

product surveillance activities and other 

sources of product information. 

DATES: Important dates are as follows: 

1. The supplemental application due 

date is December 13, 2010. 

2. The award anticipated start date is 

January 1, 2011. 

3. The opening date is November 30, 

2010. 

4. The expiration date is December 14, 

2010. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Melissa Robb, Office of Medical Policy, 

Food and Drug Administration, 10903 

New Hampshire Ave, Bldg. 51, rm. 

6360, Silver Spring, MD 20993–0002, 

301–796–2500, e-mail: 

Melissa.Robb@fda.hhs.gov; or 

Camille R. Peake, Division of 

Acquisition Support and Grants, Food 

and Drug Administration, 5630 

Fishers Lane (HFA–500), Rockville, 

MD 20857, 301–827–7175, FAX: 301– 

827–7101, e-mail: 

Camille.Peake@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


jdjones on DSK8KYBLC1PROD with NOTICES