3608 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

Dated: January 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01113 Filed 1–22–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0915] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Nonprescription 

Human Drug Products Marketed 

Without an Approved Application 

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 FDA guidance for industry on 

‘‘Postmarketing Adverse Event 

Reporting for Nonprescription Human 

Drug Products Marketed Without an 

Approved Application.’’ This guidance 

document provides recommendations 

on postmarketing serious adverse event 

reporting for nonprescription (over-thecounter) human drugs marketed without 

an approved application. It provides 

recommendations on the minimum data 

elements that should be included in a 

serious adverse event report, the label 

that should be included with the report, 

reporting formats for paper and 

electronic submissions, and how and 

where to submit the reports. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 24, 2015. 

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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. 

Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application (OMB Control 

Number 0910–0636)—Extension 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors whose name (under 

section 502(b)(1) (21 U.S.C. 352(b)(1)) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act)) appears on the label 

of a nonprescription drug marketed in 

the United States. FDA is requesting 

public comment on estimates of annual 

submissions from these respondents, as 

required by the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (Pub. L. 109–462) and 

described in the guidance. The guidance 

document discusses what should be 

included in a serious adverse drug event 

report submitted under section 760(b)(1) 

(21 U.S.C. 379aa(b)(1)) of the FD&C Act, 

including follow-up reports under 

760(c)(2) (21 U.S.C. 379aa(c)(2)) of the 

FD&C Act, and how to submit these 

reports. The estimates for the annual 

reporting and recordkeeping burdens 

are based on FDA data on the number 

of adverse drug experience reports 

submitted for nonprescription drug 

products marketed without an approved 

application, including FDA’s knowledge 

about the time needed to prepare the 

reports and to maintain records. 

Based on FDA data, we estimate 

between 10,000 and 15,000 (i.e., 

approximately 12,500) total annual 

responses from approximately 50 

respondents for nonprescription drugs 

marketed without an approved 

application, and we also estimate that 

each submission will take 

approximately 2 hours to prepare and 

submit. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

Reports of serious adverse drug events (21 U.S.C. 

379aa((b) and (c)) ............................................................ 50 250 12,500 2 25,000 

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


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 3609 

Section 760(e) (21 U.S.C. 379aa(e) of 

the FD&C Act also requires that 

responsible persons maintain records of 

nonprescription adverse event reports, 

whether or not the event is serious, for 

a period of 6 years. The guidance 

document recommends that 

respondents maintain records of efforts 

to obtain the minimum data elements 

for a report of a serious adverse drug 

event and any follow-up reports. We 

estimate that there are approximately 

20,000 records per year maintained by 

approximately 200 respondents, and 

that it takes approximately 5 hours to 

maintain each record. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 200 100 20,000 5 100,000 

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

Therefore, the estimated annual 

reporting burden for this information is 

25,000 hours and the estimated annual 

recordkeeping burden is 100,000 hours. 

Dated: January 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01111 Filed 1–22–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Science Board to the Food 

and Drug Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Science Board to the Food and Drug 

Administration, Office of the 

Commissioner, Office of the Chief 

Scientist. FDA seeks to include the 

views of women and men, members of 

all racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before March 24, 2015 will be given first 

consideration for membership on the 

Science Board to the Food and Drug 

Administration. Nominations received 

after March 24, 2015 will be considered 

for nomination to the committee as later 

vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by logging into the FDA 

Advisory Nomination Portal: http://

www.accessdata.fda.gov/scripts/

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership, the primary contact is: 

Martha Monser, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3309, Silver Spring, 

MD 20993–0002, 301–796–4627, 

martha.monser@fda.hhs.gov. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

Web site by using the following link: 

http://www.fda.gov/

AdvisoryCommittees/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nomination for voting 

members on the Science Board to the 

Food and Drug Administration. 

I. General Description of the Committee 

Duties 

The Science Board shall provide 

advice to the Commissioner and other 

appropriate officials on specific 

complex scientific and technical issues 

important to FDA and its mission, 

including emerging issues within the 

scientific community. Additionally, the 

Science Board will provide advice that 

supports the Agency in keeping pace 

with technical and scientific 

developments, including in regulatory 

science, provide input into the Agency’s 

research agenda, and on upgrading its 

scientific and research facilities and 

training opportunities. It will also 

provide, where requested, expert review 

of Agency sponsored intramural and 

extramural scientific research programs. 

II. Criteria for Voting Members 

The committee consists of a core of 21 

voting members including the chair and 

a co-chair. Members, the chair and the 

co-chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of: Food science, safety, and nutrition; 

chemistry, pharmacology, translational 

and clinical medicine and research, 

toxicology, biostatistics, medical 

devices, imaging, robotics, cell and 

tissue based products, regenerative 

medicine, public health and 

epidemiology, international health and 

regulation, product safety, product 

manufacturing sciences and quality; and 

other scientific areas relevant to FDA 

regulated products such as systems 

biology, informatics, nanotechnology, 

and combination products. Almost all 

non-Federal members of this committee 

serve as Special Government 

Employees. Members will be invited to 

serve for terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete resume or curriculum vitae for 

each nominee, including current 

business address and/or home address, 

telephone number, and email address if 

available. Nominations must also 

specify the advisory committee for 

which the nominee recommended. 

Nominations must also acknowledge 

that the nominee is aware of the 

nomination unless self-nominated. FDA 

will ask potential candidates to provide 

detailed information concerning such 

matters related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 


tkelley on DSK3SPTVN1PROD with NOTICES