58316 Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0386] 

Draft Guidance for Industry on 

Postmarketing Adverse Event 

Reporting for Nonprescription Human 

Drug Products Marketed Without an 

Approved Application; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Postmarketing 

Adverse Event Reporting for 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application.’’ This draft guidance 

document provides guidance to industry 

on postmarketing serious adverse event 

reporting for nonprescription (over-thecounter (OTC)) human drugs marketed 

without an approved application. It 

gives guidance 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. Separate 

guidance, issued by the Center for Food 

Safety and Applied Nutrition on 

reporting for dietary supplements, is 

announced elsewhere in this issue of 

the Federal Register. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance, including comments 

regarding proposed collection of 

information, by December 14, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance, 

including comments regarding proposed 

collection of information, to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD, 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments or 

http://www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Frost, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4312, 

Silver Spring, MD 20993–0002, 301–

796–2380. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Postmarketing Adverse Event 

Reporting for Nonprescription Human 

Drug Products Marketed Without an 

Approved Application.’’ Public Law 

109–462, the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act, which was signed by the 

President on December 22, 2006, states: 

‘‘Not later than 270 days after the date 

of enactment of this Act, the Secretary 

of Health and Human Services shall 

issue guidance on the minimum data 

elements that should be included in a 

serious adverse event report as 

described under the amendments made 

by this Act’’ (section 2(e)(3)). Public 

Law 109–462 also requires certain 

postmarketing safety reports for dietary 

supplements. 

Public Law 109–462 amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) to add safety reporting 

requirements for nonprescription drug 

products that are marketed without an 

approved application. In accordance 

with section 760(b) of the act (21 U.S.C. 

379aa), the manufacturer, packer, or 

distributor whose name appears on the 

label of a nonprescription drug 

marketed in the United States without 

an approved application (referred to as 

the responsible person) must submit to 

FDA any report of a serious adverse 

event associated with such drug when 

used in the United States, accompanied 

by a copy of the label on or within the 

retail package of such drug. In addition, 

the responsible person must submit 

followup reports of new medical 

information related to a submitted 

serious adverse event report that is 

received within 1 year of the initial 

report (section 760(c)(2) of the act). The 

guidance document provides 

information on: (1) The minimum data 

elements that should be included in a 

serious adverse event report; (2) the 

label that should be included with the 

report; (3) reporting formats for paper 

and electronic submissions; and (4) how 

and where to submit the reports. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on postmarketing adverse event 

reporting for nonprescription human 

drug products marketed without an 

approved application. It does not 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) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one copy. 

Comments are to be identified 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. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3520) (the PRA), 

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 below. 

With respect to the following 

collection of information, FDA invites 

comment on: (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 


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Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices 58317 

burden of the collection on respondents, 

including through the use of automated 

collection techniques, when 

appropriate, and other forms of 

information technology. 

Title: Postmarketing Adverse Event 

Reporting and Recordkeeping for 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors whose name (pursuant 

to section 502(b)(1) of the act) appears 

on the label of a nonprescription drug 

marketed in the United States. 

Burden Estimate: FDA is requesting 

public comment on estimates of annual 

submissions from these respondents, 

expected in 2008, as required by Public 

Law 109–462 and described in this 

guidance. This guidance document 

discusses what should be included in a 

serious adverse drug event report 

submitted under section 760(b)(1) of the 

act, including follow-up reports under 

760(c)(2) of the act, and how to submit 

these reports. The estimates for annual 

reporting burden and recordkeeping are 

based on FDA’s knowledge of adverse 

drug experience reports historically 

submitted per year for prescription drug 

products and for nonprescription drug 

products marketed under an approved 

application, including knowledge about 

the time needed to prepare the reports 

and to maintain records. 

FDA receives approximately 2,500 

serious adverse event reports for 

nonprescription drug products marketed 

under approved applications, which 

comprise approximately 20 percent of 

the overall nonprescription drug market. 

Based on this experience, we estimate 

between 10,000 and 15,000 (i.e., 12,500) 

total annual responses for 

nonprescription drugs marketed without 

an approved application. FDA estimates 

the burden of this collection of 

information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

No. of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours 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 

Total 25,000 

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

Section 760(e) of the 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 

draft guidance recommends that 

responsible persons maintain records of 

efforts to obtain the minimum data 

elements for a report of a serious 

adverse drug event and any followup 

reports. Although the guidance does not 

provide recommendations on 

recordkeeping activities generally under 

section 760(e) of the act, FDA is 

providing an estimate for the burden of 

this collection. Historically, serious 

adverse event reports comprise 

approximately two-thirds, and 

nonserious adverse event reports 

comprise approximately one-third, of 

the total number of postmarketing 

adverse event reports associated with 

drugs and biologic therapeutics (except 

vaccines) received by FDA. Based on 

this generalization, FDA estimates the 

total annual records to be approximately 

20,000 records per year. FDA estimates 

that it takes 5 hours to maintain each 

record and the recordkeeping burden as 

follows: 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

No. of 

recordkeepers 

Annual frequency 

per recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

Recordkeeping (21 U.S.C. 

379aa(e)(1)) 200 100 20,000 5 100,000 

Total 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: October 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–5073 Filed 10–11–07; 11:34 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

Part M of the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services at 72, Number 188, 

page 55232, September 28, 2007, is 


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