11134 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

II. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

parts 312 and 314 have been approved 

under OMB control numbers 0910–0014 

and 0910–0001, respectively. The 

collections of information referred to in 

the guidance for clinical trial sponsors 

‘‘Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581. 

III. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4290 Filed 2–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0610] 

Guidance for Industry on 

Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic.’’ The guidance 

discusses FDA’s intended approach to 

enforcement of adverse event reporting 

requirements for drugs, biologics, 

medical devices, and dietary 

supplements during an influenza 

pandemic. The Agency makes 

recommendations to industry for 

focusing limited resources on reports 

related to products indicated for the 

prevention and treatment of influenza 

and other specific types of reports 

indicated in the guidance. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this 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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

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: 

Regarding pandemic influenza: 

Carmen Maher, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

4146, Silver Spring, MD 20993–0002, 

301–796–8510. 

Regarding human drug products: Toni 

Piazza-Hepp, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4480, Silver Spring, 

MD 20993–0002, 301–796–0520. 

Regarding human biological products: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–6210. 

Regarding medical device products: 

Deborah Moore, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3230, Silver Spring, 

MD 20993–0002, 301–796–6106. 

Regarding dietary supplements: John 

Sheehan, Center for Food Safety and 

Applied Nutrition (HFS–315), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1488. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic.’’ FDA anticipates 

that during an influenza pandemic, 

industry and FDA workforces may be 

reduced while reporting of adverse 

events related to widespread use of 

medical products indicated for the 

treatment and prevention of influenza 

may increase, although the extent of 

these possible changes is unknown. The 

guidance discusses FDA’s intended 

approach to enforcement of adverse 

event reporting requirements for drugs, 

biologics, medical devices, and dietary 

supplements during an influenza 

pandemic. 

The guidance provides 

recommendations for planning, 

notification, and documentation for 

firms that report postmarketing adverse 

events. The guidance recommends that 

each firm’s pandemic influenza 

continuity of operations plan include 

instructions for reporting adverse events 

and a plan for the submission of stored 

reports that were not submitted within 

regulatory timeframes. The guidance 

recommends that firms that are unable 

to fulfill normal adverse event reporting 

requirements during an influenza 

pandemic do the following: 

• Document the conditions that 

prevent them from meeting normal 

reporting requirements, 

• Notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when these conditions exist and when 

the reporting process is restored, and 

• Maintain records to identify what 

reports have been stored. 

This guidance does not address 

monitoring and reporting of adverse 

events that might be imposed as a 

condition of authorization for products 

authorized for emergency use under 

section 564 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 360bbb–3). This guidance also 

does not address monitoring and 

reporting of adverse events as required 

by regulations establishing the 

conditions for investigational use of 

drugs, biologics, and devices. (See 21 

CFR parts 312 and 812.) 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on postmarketing 

adverse event reporting for medical 

products and dietary supplements 

during pandemic influenza. It does not 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 11135 

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. The Paperwork Reduction Act of 

1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

this guidance was approved under OMB 

control number 0910–0701. 

The guidance also refers to previously 

approved collections of information 

found in FDA’s adverse event reporting 

requirements in 21 CFR 310.305, 314.80, 

314.98, 600.80, 606.170, 640.73, 

1271.350, and 21 CFR part 803. These 

regulations contain collections of 

information that are subject to review by 

OMB under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520) and 

are approved under OMB control 

numbers 0910–0116, 0910–0291, 0910– 

0230, 0910–0308, 0910–0437, and 0910– 

0543. In addition, the guidance also 

refers to adverse event reports for 

nonprescription human drug products 

marketed without an approved 

application and dietary supplements 

required under sections 760 and 761 of 

the FD&C Act (21 U.S.C. 379aa and 

379aa–1), which include collections of 

information approved under OMB 

control numbers 0910–0636 and 0910– 

0635. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/

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

gov/BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

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

gov/MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/

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

GuidanceComplianceRegulatory

Information/GuidanceDocuments/

default.htm, or http://

www.regulations.gov. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4288 Filed 2–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request: STAR METRICS 

(Science and Technology for 

America’s Reinvestment: Measuring 

the EffecTs of Research on Innovation, 

Competitiveness and Science) 

Summary: Under the provisions of 

section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of the 

Director, National Institutes of Health 

(NIH) has submitted to the Office of 

Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on Oct 5, 2011 and allowed 60 

days for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Institutes of Health may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Proposed Collection: Title: STAR 

METRICS (Science and Technology for 

America’s Reinvestment: Measuring the 

EffecTs of Research on Innovation, 

Competitiveness and Science). Type of 

Information Collection Request: 

Extension of OMB number 0925–0616, 

expiration date 03/31/2012. Need and 

Use of Information Collection: The aim 

of STAR METRICS is twofold. The goal 

of STAR METRICS is to continue to 

provide mechanisms that will allow 

participating universities and Federal 

agencies with a reliable and consistent 

means to account for the number of 

scientists and staff that are on research 

institution payrolls, supported by 

federal funds. In subsequent generations 

of the program, it is hoped that STAR 

METRICS will allow for measurement of 

science impact on economic outcomes 

(such as job creatfon), on knowledge 

generation (such as citations, and 

patents) as well as on social and health 

outcomes. 

Frequency of Response: Quarterly.∼ 

Affected Public: Universities and 

other research institutions. 

Type of Respondents: University 

administrators. 

The annual reporting burden is as 

follows: 

Estimated Number of Respondent: 

100. 

Estimated Number of Responses per 

Respondent: 4. 

Average Burden Hours per Response: 

2.5. 

Estimated Total Annual Burden 

Hours Requested: 1,315. 

The annualized cost to respondents is 

estimated to be $65,750. There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS

Number of 

respondents 

Frequency 

of response 

Average time 

per response 

(in hours) 

Annual hour 

burden 

Stage I: One time data input ........................................................................... 7 1 45 315 

Stage 2: Ongoing quarterly data input ............................................................ 100 4 2.5 1,000 

Total .......................................................................................................... ........................ ........................ ........................ 1,315 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the functioning of the 

National Cancer Institute, including 

whether the information will have 

practical utility; (2) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 


srobinson on DSK4SPTVN1PROD with NOTICES