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, 45222-45223 [E9-21093]
Download as PDF
<![CDATA[
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
mstockstill on DSKH9S0YB1PROD with NOTICES
Persons with access to the Internet
may obtain the guidance at https://
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
VerDate Nov<24>2008
17:18 Aug 31, 2009
Jkt 217001
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 https://
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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
E:\FR\FM\01SEN1.SGM
01SEN1
Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
45223
Dated: August 26, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–21093 Filed 8–31–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
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. 0190–0640.
mstockstill on DSKH9S0YB1PROD with NOTICES
application that are labeled on or after
January 1, 2010), because the agency
was still in the process of finalizing the
guidance. The agency has now
completed its review and evaluation of
the comments received and has
modified the guidance where
appropriate.
The document provides guidance to
industry on the following topics: (1) The
meaning of ‘‘domestic address’’ for
purposes of the labeling requirements of
section 502(x) 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 labeling under section 502(x) of
the act (21 U.S.C. 352(x)); and (3) that
FDA intends to begin enforcing the
labeling requirements of section 502(x)
of the act for products labeled on or
after September 30, 2010.
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 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 alternative
approach may be used if such approach
satisfies the requirement of the
applicable statutes and regulations.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism, Initial
Review Group Biomedical Research Review
Subcommittee.
Date: October 26–27, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle, NW., Washington, DC 20005.
Contact Person: Philippe Marmillot, PhD,
Scientific Review Officer, National Institutes
of Health, National Institute on Alcohol
Abuse and Alcoholism, 5635 Fishers Lane,
Rm. 2019, Bethesda, MD 20892. 301–443–
2861. marmillotp@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271 Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
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 are available for public
examination 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
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/ default.htm or https://
www.regulations.gov.
VerDate Nov<24>2008
17:18 Aug 31, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
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 meeting.
The meeting 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.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Dated: August 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20860 Filed 8–31–09; 8:45 am]
Frm 00065
Fmt 4703
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 meeting.
The meeting 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.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Initial
Review; Group Neuroscience Review
Subcommittee.
Date: November 16–17, 2009.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel—Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Beata Buzas, PhD,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Rm
2081, Rockville, MD 20852, 301–443–0800,
bbuzas@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271 Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: August 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20865 Filed 8–31–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
BILLING CODE 4140–01–M
PO 00000
National Institutes of Health
Sfmt 4703
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45222-45223]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21093]
-----------------------------------------------------------------------
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 https://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
[[Page 45223]]
application that are labeled on or after January 1, 2010), because the
agency was still in the process of finalizing the guidance. The agency
has now completed its review and evaluation of the comments received
and has modified the guidance where appropriate.
The document provides guidance to industry on the following topics:
(1) The meaning of ``domestic address'' for purposes of the labeling
requirements of section 502(x) 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
labeling under section 502(x) of the act (21 U.S.C. 352(x)); and (3)
that FDA intends to begin enforcing the labeling requirements of
section 502(x) of the act for products labeled on or after September
30, 2010.
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 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 alternative approach may be used if such approach satisfies
the requirement 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. 0190-0640.
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 are available for
public examination 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ default.htm or
https://www.regulations.gov.
Dated: August 26, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21093 Filed 8-31-09; 8:45 am]
BILLING CODE 4160-01-S
