Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability, 75438-75439 [E8-29303]

Download as PDF 75438 Federal Register / Vol. 73, No. 239 / Thursday, December 11, 2008 / Notices Dated: December 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29301 Filed 12–8–08; 11:15 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OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0209] (formerly Docket No. 2007D–0491) Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. mstockstill on PROD1PC66 with NOTICES SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance document entitled ‘‘Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.’’ This revised draft guidance is intended to assist the industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). The revised draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register. DATES: You can submit written or electronic comments on this revised draft guidance, or any guidance, at any time (see 21 CFR 10.115(g)(5)). ADDRESSES: Submit written requests for single copies of the revised draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS–800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint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 requests. Submit written comments on VerDate Aug<31>2005 17:27 Dec 10, 2008 Jkt 217001 the revised draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 on the revised draft guidance to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the revised draft 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 FDA is announcing the availability of a revised draft guidance entitled ‘‘Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.’’ On December 22, 2006, the President signed into law the 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 reports of serious adverse events associated with its use. 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.’’ 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 on the draft guidance by March 3, 2008. Because the agency is still in the process of finalizing the guidance, FDA is issuing this revised draft guidance to notify the dietary supplement industry and other members of the public that it intends to exercise enforcement discretion with regard to the labeling PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 requirements of section 403(y) of the act for an additional 1-year period. The draft guidance issued on January 2, 2008 stated that FDA intended to begin enforcing the requirements of section 403(y) of the act for dietary supplements labeled on or after January 1, 2009. This revised draft guidance remains identical to the draft guidance issued on January 2, 2008, in all respects except that it states that FDA intends to begin enforcing the labeling requirements of section 403(y) of the act for dietary supplements labeled on or after January 1, 2010. FDA is issuing this revised draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The revised draft guidance represents the agency’s current thinking on 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 Under the Paperwork Reduction Act of 1995 (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 before submitting the collection to OMB for approval. To comply with this requirement, FDA’s notice in the Federal Register announcing the availability of the draft guidance (73 FR 197) also gave notice of the proposed collections of information in the draft guidance, included an analysis and burden estimate for these proposed collections of information, and provided 60 days for public comment under the PRA. Because this revised draft guidance makes no change, other than to change the date on which FDA intends to begin enforcing the labeling requirements of section 403(y) of the act for dietary supplements, FDA is not providing a revised PRA analysis and burden estimate in this document. E:\FR\FM\11DEN1.SGM 11DEN1 Federal Register / Vol. 73, No. 239 / Thursday, December 11, 2008 / Notices III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the revised draft 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the revised draft guidance at https://www.cfsan.fda.gov/ guidance.html. Dated: December 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29303 Filed 12–8–08; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0025] (formerly Docket No. 2007D–0083) Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval—the Premarket Approval Supplement Decisionmaking Process; Availability AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement Decision-Making Process.’’ The purpose of this guidance is to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified. VerDate Aug<31>2005 17:27 Dec 10, 2008 Jkt 217001 DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Modifications to Devices Subject to Premarket Approval (PMA)— the PMA Supplement Decision-Making Process,’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850; or to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to CDRH at 240–276–3151. The guidance document may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning 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 https:// www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4010; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA developed this guidance to address modifications to devices subject to PMA applications, including changes to device design, device labeling, and the device manufacturing process. This guidance also can be applied when a legally marketed class III device is the subject of a recall or field corrective action and the manufacturer needs to change the device to assure its safety and effectiveness. In the Federal Register of March 27, 2007 (72 FR 14282), FDA invited PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 75439 interested persons to comment on its draft guidance document entitled, ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement Decision-Making Process.’’ The five general categories of comments received regarding the draft guidance are as follows: (1) Requests for a clearer interpretation of the regulations as to when a supplement is necessary (i.e., when a change to a device impacts or could impact safety and/or effectiveness); (2) requests for a detailed flowchart that would identify the type of supplement to be submitted based on any specific change for any device; (3) requests for specific definitions for some terms, such as ‘‘substantial clinical data,’’ ‘‘significant change,’’ and ‘‘limited confirmatory clinical data;’’ (4) requests for FDA to include 30-day supplements within the scope of the guidance; and (5) requests for additional examples for many supplement types, as well as for periodic reports. We considered all of the comments and revised the guidance when appropriate. II. Significance of Guidance 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 ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement DecisionMaking Process.’’ 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement DecisionMaking Process,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240– 276–3151 to receive a hard copy. Please use the document number (1584) to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 73, Number 239 (Thursday, December 11, 2008)]
[Notices]
[Pages 75438-75439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29303]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0209] (formerly Docket No. 2007D-0491)


Draft Guidance for Industry: Questions and Answers Regarding the 
Labeling of Dietary Supplements as Required by the Dietary Supplement 
and Nonprescription Drug Consumer Protection Act: Revision 1; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance document entitled ``Draft 
Guidance for Industry: Questions and Answers Regarding the Labeling of 
Dietary Supplements as Required by the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act: Revision 1.'' This 
revised draft guidance is intended to assist the industry in complying 
with the labeling requirements prescribed for dietary supplement 
manufacturers, packers, and distributors by the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act (the DSNDCPA). The revised 
draft guidance changes the date on which FDA intends to begin enforcing 
these labeling requirements. Separate guidance, issued by the Center 
for Drug Evaluation and Research on labeling requirements for 
nonprescription (over-the-counter) human drugs marketed without an 
approved application, is announced elsewhere in this issue of the 
Federal Register.

DATES:  You can submit written or electronic comments on this revised 
draft guidance, or any guidance, at any time (see 21 CFR 10.115(g)(5)).

ADDRESSES:  Submit written requests for single copies of the revised 
draft 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 requests. Submit written comments on the revised 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 on the revised draft guidance to https://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the revised draft 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

    FDA is announcing the availability of a revised draft guidance 
entitled ``Draft Guidance for Industry: Questions and Answers Regarding 
the Labeling of Dietary Supplements as Required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act: Revision 
1.'' On December 22, 2006, the President signed into law the 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 reports of serious 
adverse events associated with its use.
    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.'' 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 on the 
draft guidance by March 3, 2008.
    Because the agency is still in the process of finalizing the 
guidance, FDA is issuing this revised draft guidance to notify the 
dietary supplement industry and other members of the public that it 
intends to exercise enforcement discretion with regard to the labeling 
requirements of section 403(y) of the act for an additional 1-year 
period. The draft guidance issued on January 2, 2008 stated that FDA 
intended to begin enforcing the requirements of section 403(y) of the 
act for dietary supplements labeled on or after January 1, 2009. This 
revised draft guidance remains identical to the draft guidance issued 
on January 2, 2008, in all respects except that it states that FDA 
intends to begin enforcing the labeling requirements of section 403(y) 
of the act for dietary supplements labeled on or after January 1, 2010.
    FDA is issuing this revised draft guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidance represents the agency's current thinking on 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

    Under the Paperwork Reduction Act of 1995 (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 before submitting the collection to OMB for 
approval. To comply with this requirement, FDA's notice in the Federal 
Register announcing the availability of the draft guidance (73 FR 197) 
also gave notice of the proposed collections of information in the 
draft guidance, included an analysis and burden estimate for these 
proposed collections of information, and provided 60 days for public 
comment under the PRA. Because this revised draft guidance makes no 
change, other than to change the date on which FDA intends to begin 
enforcing the labeling requirements of section 403(y) of the act for 
dietary supplements, FDA is not providing a revised PRA analysis and 
burden estimate in this document.

[[Page 75439]]

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the revised 
draft 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the revised draft 
guidance at https://www.cfsan.fda.gov/guidance.html.

    Dated: December 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29303 Filed 12-8-08; 11:15 am]
BILLING CODE 4160-01-S

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