Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability, 75436-75438 [E8-29301]
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75436
Federal Register / Vol. 73, No. 239 / Thursday, December 11, 2008 / Notices
Executive Order 13179, issued on
December 7, 2000, delegated authorities
assigned to ‘‘the President’’ under the
Act to the Departments of Labor, Health
and Human Services, Energy and
Justice. The Department of Health and
Human Services (DHHS) was delegated
the responsibility of establishing
methods for estimating radiation doses
received by eligible claimants with
cancer applying for compensation.
NIOSH is applying the following
methods to estimate the radiation doses
of individuals applying for
compensation.
In performance of its dose
reconstruction responsibilities, under
the Act, NIOSH is providing voluntary
interview opportunities to claimants (or
their survivors) individually and
providing them with the opportunity to
assist NIOSH in documenting the work
history of the employee by
characterizing the actual work tasks
performed. In addition, NIOSH and the
claimant may identify incidents that
may have resulted in undocumented
radiation exposures, characterizing
radiological protection and monitoring
practices, and identify co-workers and
other witnesses as may be necessary to
confirm undocumented information. In
this process, NIOSH uses a computer
assisted telephone interview (CATI)
system, which allows interviews to be
conducted more efficiently and quickly
as opposed to a paper-based interview
instrument. Both interviews are
voluntary and failure to participate in
either or both interviews will not have
a negative effect on the claim, although
voluntary participation may assist the
claimant by adding important
information that may not be otherwise
available.
NIOSH uses the data collected in this
process to complete an individual dose
reconstruction that accounts, as fully as
possible, for the radiation dose incurred
by the employee in the line of duty for
DOE nuclear weapons production
programs. After dose reconstruction,
NIOSH also performs a brief, voluntary
final interview with the claimant to
explain the results and to allow the
claimant to confirm or question the
records NIOSH has compiled. This will
also be the final opportunity for the
claimant to supplement the dose
reconstruction record.
At the conclusion of the dose
reconstruction process, the claimant
submits a form to confirm that the
claimant has no further information to
provide to NIOSH about the claim at
this time. The form notifies the claimant
that signing the form allows NIOSH to
forward a dose reconstruction report to
Department of Labor (DOL) and to the
claimant, and closes the record on data
used for the dose reconstruction.
Signing this form does not indicate that
the claimant agrees with the outcome of
the dose reconstruction. The dose
reconstruction results will be supplied
to the claimant and to the DOL, the
agency that will utilize them as one part
of its determination of whether the
claimant is eligible for compensation
under the Act.
There is no cost to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Number of responses per
respondent
Average burden (in hours)
Total response
burden hours
Initial interview .................................................................................................
Conclusion Form ..............................................................................................
4,200
8,400
1
1
1
5/60
4,200
700
Total ..........................................................................................................
........................
........................
........................
4,900
Dated: December 5, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Office of
the Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. E8–29322 Filed 12–10–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on PROD1PC66 with NOTICES
Centers for Disease Control and
Prevention/Health Resources and
Services Administration (CDC/HRSA)
Advisory Committee on HIV and STD
Prevention and Treatment
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the CDC/
HRSA Advisory Committee on HIV and
STD Prevention and Treatment,
Department of Health and Human
Services, has been renewed for a 2-year
period through November 25, 2010.
VerDate Aug<31>2005
17:27 Dec 10, 2008
Jkt 217001
FOR FURTHER INFORMATION CONTACT:
contact Kevin Fenton, M.D., Ph.D.,
Executive Secretary, CDC/HRSA
Advisory Committee on HIV and STD
Prevention and Treatment, Department
of Health and Human Services, 1600
Clifton Road, NE., Mailstop E07,
Atlanta, Georgia 30333, telephone (404)
639–8000 or fax (404) 639–8600.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: December 4, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–29325 Filed 12–10–08; 8:45 am]
BILLING CODE 4163–18–P
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0429] (formerly
Docket No. 2007D–0496)
Draft Guidance for Industry on
Questions and Answers Regarding the
Labeling of Nonprescription Human
Drug Products Marketed Without an
Approved Application 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
entitled ‘‘Questions and Answers
Regarding the Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
E:\FR\FM\11DEN1.SGM
11DEN1
Federal Register / Vol. 73, No. 239 / Thursday, December 11, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
Consumer Protection Act: Revision 1.’’
This revised draft 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. The revision of the draft
guidance changes the date on which
FDA intends to begin enforcing these
labeling requirements. 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: 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 Division of Drug
Information (HFD–240), Center for Drug
Evaluation and Research, Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one
self-addressed adhesive label 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 to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revised draft
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, 301–796–
2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance entitled
‘‘Questions and Answers Regarding the
Labeling of Nonprescription Human
Drug Products Marketed Without an
Approved Application as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act: Revision 1.’’ On
December 22, 2006, the President signed
into law the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (Public Law 109–462,
120 Stat. 3469). This law amends the
Federal Food, Drug, and Cosmetic Act
(the act) with respect to serious adverse
VerDate Aug<31>2005
17:27 Dec 10, 2008
Jkt 217001
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 issued a draft
guidance document containing
questions and answers relating to the
new labeling requirements under Public
Law 109–462 for OTC drugs marketed
without an approved application.
Although interested parties can
comment on any guidance at any time,
to ensure that the agency considered
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. FDA is still working to
finalize the guidance.
Because the agency is still in the
process of finalizing the guidance, FDA
is issuing this revised draft guidance to
notify industry that it intends to
exercise enforcement discretion with
regard to these labeling requirements 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
502(x) of the act for OTC drug products
marketed without an approved
application that are labeled on or after
January 1, 2009. The revised draft
guidance remains identical to the draft
guidance issued on January 2, 2008,
with respect to all topics except that it
states that FDA intends to begin
enforcing the labeling requirements of
section 502(x) of the act for OTC drug
products marketed without an approved
application that are labeled on or after
January 1, 2010.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent 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
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
75437
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 gave notice of the proposed
collections of information in the draft
guidance. The notice 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 502(x) of the act
for OTC drug products marketed
without an approved application, FDA
is not providing a revised PRA analysis
and burden estimate in this notice.
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 are
available for public examination 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 document at https://
www.fda.gov/cder/guidance/index.htm.
E:\FR\FM\11DEN1.SGM
11DEN1
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
]]>Agencies
[Federal Register Volume 73, Number 239 (Thursday, December 11, 2008)]
[Notices]
[Pages 75436-75438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29301]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0429] (formerly Docket No. 2007D-0496)
Draft Guidance for Industry on Questions and Answers Regarding
the Labeling of Nonprescription Human Drug Products Marketed Without an
Approved Application 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 entitled ``Questions and
Answers Regarding the Labeling of Nonprescription Human Drug Products
Marketed Without an Approved Application as Required by the Dietary
Supplement and Nonprescription Drug
[[Page 75437]]
Consumer Protection Act: Revision 1.'' This revised draft 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. The revision of the
draft guidance changes the date on which FDA intends to begin enforcing
these labeling requirements. 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: 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 Division of Drug Information (HFD-240), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive
label 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 to https://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the revised draft 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, 301-796-
2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance
entitled ``Questions and Answers Regarding the Labeling of
Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Revision 1.'' On December 22, 2006, the
President signed into law the Dietary Supplement and Nonprescription
Drug Consumer Protection Act (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 issued
a draft guidance document containing questions and answers relating to
the new labeling requirements under Public Law 109-462 for OTC drugs
marketed without an approved application. Although interested parties
can comment on any guidance at any time, to ensure that the agency
considered 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. FDA is still working to finalize the
guidance.
Because the agency is still in the process of finalizing the
guidance, FDA is issuing this revised draft guidance to notify industry
that it intends to exercise enforcement discretion with regard to these
labeling requirements 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 502(x) of the act for OTC drug
products marketed without an approved application that are labeled on
or after January 1, 2009. The revised draft guidance remains identical
to the draft guidance issued on January 2, 2008, with respect to all
topics except that it states that FDA intends to begin enforcing the
labeling requirements of section 502(x) of the act for OTC drug
products marketed without an approved application that are labeled on
or after January 1, 2010.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent 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
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 gave notice
of the proposed collections of information in the draft guidance. The
notice 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 502(x) of the act for OTC drug
products marketed without an approved application, FDA is not providing
a revised PRA analysis and burden estimate in this notice.
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
are available for public examination 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 document at
https://www.fda.gov/cder/guidance/index.htm.
[[Page 75438]]
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
