34024 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 

event report (section 2(e)(3)). The 

guidance document provides 

information on the following topics: (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. 

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). 

Public Law 109–462 also requires 

certain postmarketing safety report!s for 

dietary supplements. 

In the Federal Register of October 15, 

2007 (72 FR 58316), FDA announced the 

availability of a draft guidance of the 

same title. FDA received several 

comments on the draft guidance and 

considered those comments when 

finalizing the guidance. The guidance 

announced in this notice finalizes the 

draft guidance dated October 2007. 

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 

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. 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 collections of information in 

this guidance have been approved under 

OMB Control No. 0910–0636. 

III. 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 paper 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. 

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: July 8, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16738 Filed 7–13–09; 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) 

Guidance for Industry: Questions and 

Answers Regarding Adverse Event 

Reporting and Recordkeeping for 

Dietary Supplements as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Questions and Answers 

Regarding Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act.’’ The document provides 

guidance to the dietary supplement 

industry for complying with the serious 

adverse event reporting and 

recordkeeping requirements prescribed 

for dietary supplement manufacturers, 

packers, and distributors by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act (the 

DSNDCPA). Separate guidance, issued 

by FDA’s Center for Drug Evaluation 

and Research, on reporting for 

nonprescription (over-the-counter 

(OTC)) human drugs marketed without 

an approved application, is announced 

elsewhere in this issue of the Federal 

Register. 

DATES: Submit written or electronic 

comments on the guidance at any time. 

ADDRESSES: Submit written comments 

on the guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written requests for single 

copies of the guidance to the Office of 

Nutrition, Labeling, and Dietary 

Supplements (HFS–800), Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20750. Send two self-addressed 

adhesive labels to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Vasilios Frankos,Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration,5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2375. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 15, 

2007 (72 FR 58313), FDA announced the 

availability of a draft guidance entitled 

‘‘Questions and Answers Regarding 

Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act’’ and gave interested 

parties an opportunity to submit 

comments by December 14, 2007. The 

agency reviewed and evaluated these 

comments and has modified the 

guidance where appropriate. 

The guidance contains questions and 

answers relating to the new 

requirements under the DSNDCPA, 

concerning the mandatory reporting to 

FDA of serious adverse events 

associated with dietary supplements, 

the minimum data elements to be 

submitted in such reports, and records 

of serious and non-serious adverse 

events reported to a dietary supplement 

manufacturer, packer, or distributor. 

FDA is issuing this guidance as level 

1 guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The guidance represents the 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 34025 

agency’s current thinking on this topic. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. 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 no. 0910–0635. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the guidance. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.fda.gov/FoodGuidances or http:// 

www.regulations.gov. 

Dated: July 8, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16702 Filed 7–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0312] 

Guidance for Institutional Review 

Boards, Frequently Asked Questions— 

Institutional Review Board 

Registration; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Guidance for Institutional Review 

Boards (IRBs), Frequently Asked 

Questions — IRB Registration.’’ This 

guidance is intended to assist IRBs in 

complying with the new requirement for 

IRB registration. This new rule requires 

each IRB in the United States that 

reviews FDA-regulated research to 

register using an Internet-based 

registration system that is maintained by 

the Department of Health and Human 

Services (HHS). This registration system 

is a modification of the one currently 

used by the Office for Human Research 

Protections (OHRP) for registration of 

IRBs that are designated by institutions 

under Federalwide Assurances (FWAs). 

OHRP has issued a similar rule 

requiring IRBs designated by 

institutions under FWAs to register or 

update their registration information 

using this modified system. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written comments 

on this 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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Jean 

Toth-Allen, Office of Science and 

Health Coordination/Good Clinical 

Practice Program (HF–34), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

1585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance document for IRBs entitled, 

‘‘Guidance for Institutional Review 

Boards (IRBs), Frequently Asked 

Questions — IRB Registration.’’ This 

guidance is intended to assist IRBs in 

complying with the new requirement for 

IRB registration under amended 21 CFR 

56.106, which is effective July 14, 2009. 

Registration will be accomplished 

through a modified version of the 

Internet-based registration system used 

by OHRP for registration of IRBs that are 

designated by institutions under FWAs. 

This guidance document addresses 

basic information, such as why FDA 

issued the new rule, which IRBs are 

subject to the new regulation, the type 

of information to be provided when 

registering, and implications of noncompliance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance is being issued as a level 

1 guidance for immediate 

implementation in accordance with 21 

CFR 10.115(g). Prior public 

participation is not feasible and FDA 

believes the guidance is necessary to 

help IRBs better understand their 

responsibilities under the new 

registration rule, which will go into 

effect on July 14, 2009. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to a previously 

approved collection of information 

required by the FDA new final rule on 

registration requirements. This 

collection of information is 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 

21 CFR 56.106(b) has been approved 

under 0990–0279. 

III. Comments 

Interested persons may submit written 

or electronic comments regarding this 

document to the Division of Dockets 

Management (see ADDRESSES). Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/oc/gcp/draft.html or 

http://www.fda.gov/ohrms/dockets/ 

default.htm 

Dated: July 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16703 Filed 7–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

mstockstill on DSKH9S0YB1PROD with NOTICES