Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 53251 

OGE’s SES Performance Review Board 

as it was most recently published at 72 

FR 54666–54667 (September 26, 2007). 

Approved: September 9, 2008. 

Robert I. Cusick, 

Director, Office of Government Ethics. 

The following officials have been 

appointed as regular members of the 

SES Performance Review Board of the 

Office of Government Ethics: 

Joseph E. Gangloff [Chair], Deputy 

Director for Agency Programs, Office 

of Government Ethics; 

Don W. Fox [Alternate Chair], General 

Counsel, Office of Government Ethics; 

Daniel L. Koffsky, Special Counsel, 

Office of Legal Counsel, Department 

of Justice; 

David Maggi, Chief, Ethics Law and 

Programs Division, Office of the 

Assistant General Counsel for 

Administration, Department of 

Commerce; and 

Robert A. Shapiro, Associate Solicitor 

for Legal Counsel, Department of 

Labor. 

[FR Doc. E8–21447 Filed 9–12–08; 8:45 am] 

BILLING CODE 6345–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0434] (formerly 

Docket No. 2007D–0386) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 15, 

2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–NEW and title 

‘‘Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on 

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, amended 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). 

Section 760(e) of the act also requires 

that responsible persons maintain 

records of nonprescription drug adverse 

event reports, whether or not the event 

is serious, for a period of 6 years. 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. 

Title: Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application. 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

or distributors whose name appears on 

the label of a nonprescription drug 

marketed in the United States without 

an approved application. 

Burden Estimate: FDA is requesting 

public comment on estimates of the 

number of annual submissions from 

these respondents and recordkeeping, as 

required by Public Law 109–462 and 

described in the guidance 

‘‘Postmarketing Adverse Event 

Reporting for Nonprescription Human 

Drug Products Marketed Without an 

Approved Application.’’ The estimates 

for annual reporting and recordkeeping 

are based on FDA’s knowledge of 

adverse drug experience reports 

historically submitted annually 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 data, we estimate between 

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

annual responses from approximately 

50 respondents for nonprescription 

drugs marketed without an approved 

application, and that each submission 

will take approximately 2 hours to 

prepare and submit to FDA. 

In the Federal Register of October 15, 

2007 (72 FR 58316), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

on the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

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53252 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

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. 

The guidance also 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 

document does not provide 

recommendations on all the 

recordkeeping activities required under 

section 760(e) of the act, we are 

providing an estimate for this burden. 

Historically, serious adverse event 

reports comprise approximately twothirds, and nonserious adverse event 

reports comprise approximately onethird, of the total number of 

postmarketing adverse event reports 

associated with drugs and biologic 

therapeutics (except vaccines) received 

by FDA. Based on this generalization, 

we estimate the total annual records to 

be approximately 20,000 records per 

year, and the number of respondents to 

be approximately 200. We also estimate 

that it takes approximately 5 hours to 

maintain each record. 

TABLE 2.— ESTIMATED ANNUAL RECORDKEEPING BURDEN1

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 

collection is 25,000 hours and the 

estimated annual recordkeeping burden 

is 100,000 hours. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21345 Filed 9–12–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0372] (formerly 

Docket No. 2007D–0388) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adverse Event 

Reporting and Recordkeeping for 

Dietary Supplements as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 15, 

2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–NEW and title, 

‘‘Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act—(OMB Control Number 

0910–NEW) 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors of dietary supplements 

marketed in the United States. 

On December 22, 2006, the President 

signed into law the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act (DSNDCPA) (Public Law 

109–462, 120 Stat. 3469). This law 

amends the Federal Food, Drug, and 

Cosmetic Act (the act) with respect to 

serious adverse event reporting and 

recordkeeping for dietary supplements 

and non-prescription drugs marketed 

without an approved application. 

Under section 761(b)(1) of the act (21 

U.S.C. 379aa–1(b)(1)), the manufacturer, 

packer, or distributor whose name 

(under section 403(e)(1) of the act (21 

U.S.C. 343(e)(1))) appears on the label of 

a dietary supplement marketed in the 

United States is required to submit to 

FDA any serious adverse event report it 

receives regarding use of the dietary 

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