Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability, 22560-22561 [E9-11089]
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22560
Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Notices
EXHIBIT 3—ESTIMATED COST
Cost component
Total cost
Annualized
cost
Review of literature ..................................................................................................................................................
Cognitive interviews .................................................................................................................................................
Field test ..................................................................................................................................................................
Data analyses ..........................................................................................................................................................
Finalize survey .........................................................................................................................................................
AHRQ project management ....................................................................................................................................
$20,000
60,000
90,000
40,000
35,000
50,000
$13,334
40,000
60,000
26,667
23,334
33,334
Total ..................................................................................................................................................................
295,000
196,669
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: May 4, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–11012 Filed 5–12–09; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–D–0122] (formerly
Docket No. 2004D–0327)
Compliance Guidance for Small
Business Entities on Labeling Overthe-Counter Human Drug Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Nov<24>2008
18:44 May 12, 2009
Jkt 217001
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a compliance guidance
for small business entities entitled
‘‘Labeling OTC Human Drug Products;
Small Entity Compliance Guide.’’ FDA
has prepared this guidance in
accordance with the Small Business
Regulatory Enforcement Fairness Act. It
is intended to help small businesses
better understand and comply with the
agency’s over-the-counter (OTC)
labeling requirements and to prepare
new labeling. This compliance guidance
finalizes the draft compliance guidance
published on December 9, 2004.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this compliance
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, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
compliance 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 compliance
guidance document.
FOR FURTHER INFORMATION CONTACT:
Marina Y. Chang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5418,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a compliance guidance for small
business entities entitled ‘‘Labeling OTC
Human Drug Products; Small Entity
Compliance Guide.’’ FDA has prepared
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
this guidance in accordance with
section 212 of the Small Business
Regulatory Enforcement Fairness Act.
This is one of several guidances the
agency has developed to help
manufacturers, packers, and distributors
implement the final rule establishing
standardized content and format
requirements for the labeling of all OTC
drug products. Once finalized, these
guidances supersede all other
statements, feedback, and
correspondence provided by the agency
on these matters since the issuance of
the final rule.
In the Federal Register of March 17,
1999 (64 FR 13254), FDA published a
final rule establishing standardized
content and format requirements for the
labeling of OTC drug products (21 CFR
201.66). This regulation is intended to
standardize labeling for all OTC drug
products so consumers can easily read
and understand OTC drug product
labeling and use these products safely
and effectively. The regulation requires
manufacturers to present OTC drug
labeling information in a prescribed
order and format. The standardized
format requires revision of all existing
labeling and covers all OTC drug and
drug-cosmetic products, whether
marketed under a new drug application,
abbreviated new drug application, or
OTC drug monograph (or drug product
not yet the subject of a final OTC drug
monograph).
Following issuance of the final rule,
the agency received a number of
inquiries from manufacturers seeking
guidance on how to present the labeling
information for their OTC drug products
using the standardized content and
format requirements. To address these
inquiries, FDA published a notice in the
Federal Register of December 9, 2004
(69 FR 71420), announcing the
availability of a draft compliance
guidance for small business entities
entitled ‘‘Labeling OTC Human Drug
Products; Small Entity Compliance
Guide.’’ The draft compliance guidance
summarizes the new Drug Facts labeling
requirements set forth in § 201.66. The
E:\FR\FM\13MYN1.SGM
13MYN1
Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Notices
draft compliance guidance also
describes how to list those inactive
ingredients that are different when a
finished OTC drug product is obtained
from multiple suppliers.
The notice invited interested persons
to submit comments on the draft
compliance guidance by February 7,
2005. FDA did not receive any
comments in response to the notice, and
is announcing the availability of this
final compliance guidance with only
editorial revisions to the draft guidance.
This compliance guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The compliance guidance
represents the agency’s current thinking
on how OTC drug product labeling can
be converted to the new OTC Drug Facts
format labeling. 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. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
May 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–11089 Filed 5–12–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Fogarty International Center; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
VerDate Nov<24>2008
18:44 May 12, 2009
Jkt 217001
22561
hereby given of a meeting of the Fogarty
International Center Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
www.nih.gov/fic/aboutladvisory.html, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.106, Minority International
Research Training Grant in the Biomedical
and Behavioral Sciences; 93.154, Special
International Postdoctoral Research Program
in Acquired Immunodeficiency Syndrome;
93.168, International Cooperative
Biodiversity Groups Program; 93.934, Fogarty
International Research Collaboration Award;
93.989, Senior International Fellowship
Awards Program, National Institutes of
Health, HHS)
Name of Committee: Fogarty International
Center Advisory Board.
Date: May 18–19, 2009.
Closed: May 18, 2009, 1:30 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Lawton Chiles International House, Bethesda,
MD 20892.
Open: May 19, 2009, 8:30 a.m. to 4 p.m.
Agenda: Discussions will focus on FIC
activities and plans. Topics to be discussed:
The pros/cons of creating an FIC centers-type
grant; Priorities in distance learning
applications and public health informatics;
and future directions for the FIC framework
program.
Place: National Institutes of Health,
Lawton Chiles International House, Bethesda,
MD 20892.
Contact Person: Robert Eiss, Public Health
Advisor, Fogarty International Center,
National Institutes of Health, 31 Center Drive,
Room B2C02, Bethesda, MD 20892, (301)
496–1415, EISSR@MAIL.NIH.GOV.
This meeting is being published less than
15 days prior to the meeting due to timing
limitations imposed by administrative
matters.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, drivers license,
or passport) and to state the purpose of their
visit. Information is also available on the
Institutes/Centers home page: https://
National Institutes of Health
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Dated: May 5, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–11002 Filed 5–12–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Library of Medicine; 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.
Name of Committee: National Library of
Medicine Special Emphasis Panel;
Competitive Revision.
Date: June 12, 2009.
Time: 9 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine,
Building 38, Board Room, 2nd Floor, 8600
Rockville Pike, Bethesda, MD 20892.
Contact Person: Arthur A. Petrosian,
Scientific Review Administrator, Division of
Extramural Programs, National Library of
Medicine, 6705 Rockledge Drive, Suite 301,
Bethesda, MD 20892–7968, 301–496–4253,
petrosia@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.701, ARRA Related
Biomedical Research and Research Support
Awards, National Institutes of Health, HHS)
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 74, Number 91 (Wednesday, May 13, 2009)]
[Notices]
[Pages 22560-22561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11089]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-D-0122] (formerly Docket No. 2004D-0327)
Compliance Guidance for Small Business Entities on Labeling Over-
the-Counter Human Drug Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a compliance guidance for small business entities
entitled ``Labeling OTC Human Drug Products; Small Entity Compliance
Guide.'' FDA has prepared this guidance in accordance with the Small
Business Regulatory Enforcement Fairness Act. It is intended to help
small businesses better understand and comply with the agency's over-
the-counter (OTC) labeling requirements and to prepare new labeling.
This compliance guidance finalizes the draft compliance guidance
published on December 9, 2004.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this compliance
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, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the compliance 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
compliance guidance document.
FOR FURTHER INFORMATION CONTACT: Marina Y. Chang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5418, Silver Spring, MD 20993-0002, 301-
796-2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a compliance guidance for
small business entities entitled ``Labeling OTC Human Drug Products;
Small Entity Compliance Guide.'' FDA has prepared this guidance in
accordance with section 212 of the Small Business Regulatory
Enforcement Fairness Act. This is one of several guidances the agency
has developed to help manufacturers, packers, and distributors
implement the final rule establishing standardized content and format
requirements for the labeling of all OTC drug products. Once finalized,
these guidances supersede all other statements, feedback, and
correspondence provided by the agency on these matters since the
issuance of the final rule.
In the Federal Register of March 17, 1999 (64 FR 13254), FDA
published a final rule establishing standardized content and format
requirements for the labeling of OTC drug products (21 CFR 201.66).
This regulation is intended to standardize labeling for all OTC drug
products so consumers can easily read and understand OTC drug product
labeling and use these products safely and effectively. The regulation
requires manufacturers to present OTC drug labeling information in a
prescribed order and format. The standardized format requires revision
of all existing labeling and covers all OTC drug and drug-cosmetic
products, whether marketed under a new drug application, abbreviated
new drug application, or OTC drug monograph (or drug product not yet
the subject of a final OTC drug monograph).
Following issuance of the final rule, the agency received a number
of inquiries from manufacturers seeking guidance on how to present the
labeling information for their OTC drug products using the standardized
content and format requirements. To address these inquiries, FDA
published a notice in the Federal Register of December 9, 2004 (69 FR
71420), announcing the availability of a draft compliance guidance for
small business entities entitled ``Labeling OTC Human Drug Products;
Small Entity Compliance Guide.'' The draft compliance guidance
summarizes the new Drug Facts labeling requirements set forth in Sec.
201.66. The
[[Page 22561]]
draft compliance guidance also describes how to list those inactive
ingredients that are different when a finished OTC drug product is
obtained from multiple suppliers.
The notice invited interested persons to submit comments on the
draft compliance guidance by February 7, 2005. FDA did not receive any
comments in response to the notice, and is announcing the availability
of this final compliance guidance with only editorial revisions to the
draft guidance.
This compliance guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The compliance guidance
represents the agency's current thinking on how OTC drug product
labeling can be converted to the new OTC Drug Facts format labeling. 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. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://www.regulations.gov.
May 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11089 Filed 5-12-09; 8:45 am]
BILLING CODE 4160-01-S
