Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45221 

Dated: August 27, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21099 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0050] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Importer’s Entry Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Importer’s Entry Notice’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

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, e-mail: 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 28, 2009 (74 FR 

25554), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0046. The 

approval expires on August 31, 2012. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: August 26, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21097 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0209] (formerly 

Docket No. 2007D–0491) 

Guidance for Industry: Questions and 

Answers Regarding the Labeling of 

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 the Labeling of 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 labeling 

requirements prescribed for dietary 

supplement manufacturers, packers, and 

distributors by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act (DSNDCPA). Separate 

guidance on labeling requirements for 

nonprescription (over-the-counter) 

human drugs marketed without an 

approved application, issued by FDA’s 

Center for Drug Evaluation and 

Research, 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 

On December 22, 2006, the President 

signed into law 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 for 

dietary supplements and 

nonprescription drugs marketed without 

an approved application. The law also 

amended the act to add section 403(y) 

(21 U.S.C. 343(y)), which requires the 

label of a dietary supplement marketed 

in the United States to include a 

domestic address or domestic telephone 

number through which the product’s 

manufacturer, packer, or distributor may 

receive a report of a serious adverse 

event associated with the dietary 

supplement. 

In the Federal Register of January 2, 

2008 (73 FR 197), FDA announced the 

availability of a draft guidance entitled 

‘‘Questions and Answers Regarding the 

Labeling of Dietary Supplements as 

Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act.’’ In addition to 

providing guidance for industry on how 

to comply with the labeling 

requirements in section 403(y) of the 

act, the draft guidance stated that FDA 

intended to begin enforcing the 

requirements of section 403(y) for 

dietary supplements labeled on or after 

January 1, 2009. Although interested 

parties can comment on any guidance at 

any time, to ensure that the agency 

would have the opportunity to consider 

comments on the draft guidance before 

it began work on the final version, FDA 

requested that interested parties submit 

comments by March 3, 2008. On 

December 11, 2008 (73 FR 75438), FDA 

announced the availability of a revised 

version of the draft guidance document 

to notify the dietary supplement 

industry and other members of the 

public that it intended to exercise 

enforcement discretion with regard to 

the labeling requirements of section 

403(y) of the act for an additional 1-year 

period (i.e., for dietary supplements 

labeled before January 1, 2010) because 

the agency was still in the process of 

reviewing the comments and finalizing 

the guidance. The agency has now 

completed its review and evaluation of 

the comments received and has 

modified the guidance where 

appropriate. 

The guidance contains questions and 

answers relating to the labeling 

requirements in section 403(y) of the act 

and provides guidance to industry on 

the following topics: (1) The meaning of 

‘‘domestic address’’ for purposes of the 

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45222 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

labeling requirements of section 403(y) 

of the act; (2) FDA’s recommendation 

for the use of an introductory statement 

before the domestic address or domestic 

telephone number that is required to 

appear on the product label under 

section 403(y) of the act; and (3) that 

FDA intends to begin enforcing the 

labeling requirements of section 403(y) 

of the act for products labeled on or 

after September 30, 2010. 

FDA is issuing this guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the labeling of 

dietary supplements as required by the 

DSNDCPA. 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 were approved under 

OMB control no. 0910–0642. 

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.cfsan.fda.gov/guidance.html. 

Dated: August 26, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21094 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0429] (formerly 

Docket No. 2007D–0496] 

Guidance for Industry on Labeling of 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act: Questions 

and Answers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act: Questions and 

Answers.’’ This guidance is intended to 

assist industry in complying with the 

labeling requirements for 

nonprescription (over-the-counter 

(OTC)) human drugs marketed without 

an approved application established by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (DSNDCPA). Separate 

guidance, issued by the Center for Food 

Safety and Applied Nutrition on 

complying with the labeling 

requirements for dietary supplements, is 

announced elsewhere in this issue of 

the Federal Register. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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, 

Rockville, MD 20993–0002. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

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 to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Walter Ellenberg, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5488, 

Silver Spring, MD 20993–0002, 301– 

796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act: Questions and 

Answers.’’ On December 22, 2006, the 

President signed into law 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 for dietary supplements and 

nonprescription drugs marketed without 

an approved application. The law also 

amended the act to add section 502(x) 

(21 U.S.C. 352(x)), which requires the 

label of an OTC drug product marketed 

in the United States without an 

approved application to include a 

domestic address or domestic telephone 

number through which the product’s 

manufacturer, packer, or distributor may 

receive reports of serious adverse events 

associated with its use. 

In the Federal Register of January 2, 

2008 (73 FR 196), FDA announced the 

availability of a draft version of the 

guidance containing questions and 

answers relating to the new labeling 

requirements under Public Law 109–462 

for OTC drugs marketed without an 

approved application. In addition to 

providing guidance for industry on how 

to comply with the labeling 

requirements in section 502(x) of the 

act, the draft guidance stated that FDA 

intended to begin enforcing the 

requirements of section 502(x) for OTC 

human drugs marketed without an 

approved application labeled on or after 

January 1, 2009. Although interested 

parties can comment on any guidance at 

any time, to ensure that the agency 

would have the opportunity to consider 

comments on the draft guidance before 

beginning work on the final version of 

the guidance, FDA requested that 

interested parties submit comments by 

March 3, 2008. On December 11, 2008 

(73 FR 75436), FDA announced the 

availability of a revised draft guidance 

to notify industry and other members of 

the public that it intended to exercise 

enforcement discretion with regard to 

the labeling requirements of section 

502(x) of the act for an additional 1-year 

period (i.e., for OTC drug products 

marketed without an approved 

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