Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability, 33311-33312 [2010-14036]
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33311
Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
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Change In Scope (CIS) Site Add Checklist .......................
CIS Site Delete Checklist ..................................................
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CIS Service Add Checklist .................................................
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Board Member Characteristics ..........................................
Request for Waiver of Governance Requirements ...........
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Other Requirements for Sites ............................................
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Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: June 7, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–14108 Filed 6–10–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0433] (formerly
Docket No. 2007D–0169)
Guidance for Industry on
Bioequivalence Recommendations for
Specific Products; Availability
AGENCY:
Food and Drug Administration,
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products.’’ This guidance describes a
new process for making available
VerDate Mar<15>2010
15:04 Jun 10, 2010
Jkt 220001
recommendations on how to design
product-specific bioequivalence (BE)
studies to support abbreviated new drug
applications (ANDAs). Under this
process, applicants planning to carry
out such studies in support of their
ANDAs are able to access BE study
guidance on the FDA Web site. FDA
believes that making this information
available on the Internet will streamline
the guidance process and will provide a
meaningful opportunity for the public to
consider and comment on productspecific BE study recommendations.
DATES: Submit either electronic or
written comments on agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this 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. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD–600),
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–9314.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products.’’ This guidance
describes a new process for making
available recommendations on how to
design product-specific BE studies to
support ANDAs. Under this process,
draft and final BE recommendations are
posted on FDA’s Web site (https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, Individual
Product Bioequivalence
Recommendations) and announced
periodically in the Federal Register. For
draft BE recommendations, the Federal
Register notice will identify a comment
period. The public is encouraged to
submit comments on the draft BE
recommendations, and the agency will
consider received comments in
developing final BE recommendations.
FDA adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide an opportunity for the public to
consider and comment on those
recommendations.
In the Federal Register of May 31,
2007 (72 FR 30388), FDA announced the
availability of a draft version of this
guidance entitled ‘‘Bioequivalence
Recommendations for Specific
E:\FR\FM\11JNN1.SGM
11JNN1
33312
Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
Products.’’ The May 2007 draft guidance
gave interested persons an opportunity
to submit comments through August 29,
2007. The agency is finalizing the
guidance after considering comments
received on the draft guidance. Minor
changes were made to the draft
guidance to update FDA Web site
information.
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 a new process for
making available to sponsors FDA
guidance on how to design productspecific bioequivalence studies to
support ANDAs. 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) either electronic or written
comments regarding the guidance. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–14036 Filed 6–10–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
[Docket No. FDA–2010–N–0256]
Indexing Structured Product Labeling
for Human Prescription Drug and
Biological Products; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
VerDate Mar<15>2010
15:04 Jun 10, 2010
Jkt 220001
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER)
and Center for Biologics Evaluation and
Research (CBER) are indexing certain
categories of information in product
labeling for use as terms to search
repositories of approved prescription
medical product structured product
labeling (SPL). FDA has previously
identified pharmacologic class as a top
priority for indexing of product labeling
information. FDA is now announcing
that medical product indications is
another category of product labeling
information that the agency has
identified as a high priority for
indexing. CDER and CBER are
announcing the establishment of a
public docket to provide an opportunity
for interested parties to share
information, research, and ideas on the
FDA indexing process.
DATES: Submit either electronic or
written comments by August 10, 2010.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in the brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Colleen E. Brennan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6439,
Silver Spring, MD 20993–0002, 301–
´
796–2316; or Denise Sanchez, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
As part of the effort to advance
medical informatics to support the safe
use of medical products, CDER and
CBER are using the SPL format to index
labeling information for human
prescription drug and biological
products. SPL is a document markup
standard approved by Health Level
Seven adopted by FDA as a mechanism
for exchanging product information by
using extensible markup language.
Indexing refers to the insertion of
machine-readable tags that do not
appear in actual printed labeling, but
enable users with clinical decision
support tools and electronic prescribing
systems to rapidly search and sort
product information. This is an
important step toward the creation of a
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
fully automated health information
exchange system.
Indexed labeling can help prevent
prescription errors and enhance the safe
use of medical products. For example,
among other benefits, the SPL indexing
can enable a hospital’s computer system
to help detect that products prescribed
by the hospital to treat a patient’s injury
do not adversely interact with other
products that the patient is taking. It is
important that this indexing be done
consistently to enable comprehensive
searches to find all relevant information,
including appropriate synonyms.
In recent years, FDA pilot-tested the
addition of SPL indexing to human
prescription drug and biological product
labeling. Based on that experience,
feedback from industry, and feedback
from other SPL users, FDA’s approach
will be to index product labeling
information and link an indexed SPL
file to the content of labeling SPL file
available in the official SPL public
access repository. Considering FDA’s
available resources, we have instituted a
phased implementation of indexing for
certain categories for all human
prescription drug and biological product
labeling. Indexing information on the
pharmacologic class and indications
categories of product labeling is being
undertaken by the agency, as resources
permit (see more information below). As
the phased implementation proceeds,
all human prescription drug and
biological product labeling may be
linked to certain key indexing.
For additional information, including
the guidance for industry ‘‘Indexing
Structured Product Labeling,’’ refer to
the FDA Data Standards Council Web
page on SPL at https://www.fda.gov/
ForIndustry/DataStandards/Structured
ProductLabeling/default.htm. FDA will
update the Data Standards Council Web
site to include all SPL indexing and
their related terminologies as they are
developed.
When the indexing of pharmacologic
class and indications is complete, FDA
intends to index other categories of
product labeling information using a
phased implementation process. The
types and priority order of indexing of
subsequent categories will be
determined based on public input and
agency priorities.
II. Indexing Pharmacologic Class
In June 2008, FDA issued the
guidance for industry ‘‘Indexing
Structured Product Labeling.’’ This
guidance states the agency’s intention to
index product labeling information, as
resources permit, and identifies
pharmacologic class as a top indexing
priority. As part of its review and label
E:\FR\FM\11JNN1.SGM
11JNN1
Agencies
[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33311-33312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14036]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0433] (formerly Docket No. 2007D-0169)
Guidance for Industry on Bioequivalence Recommendations for
Specific Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Bioequivalence
Recommendations for Specific Products.'' This guidance describes a new
process for making available recommendations on how to design product-
specific bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs). Under this process, applicants planning to carry
out such studies in support of their ANDAs are able to access BE study
guidance on the FDA Web site. FDA believes that making this information
available on the Internet will streamline the guidance process and will
provide a meaningful opportunity for the public to consider and comment
on product-specific BE study recommendations.
DATES: Submit either electronic or written comments on agency
guidances at any time.
ADDRESSES: Submit written requests for single copies of this 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. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9314.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Bioequivalence Recommendations for Specific Products.'' This
guidance describes a new process for making available recommendations
on how to design product-specific BE studies to support ANDAs. Under
this process, draft and final BE recommendations are posted on FDA's
Web site (https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
Individual Product Bioequivalence Recommendations) and announced
periodically in the Federal Register. For draft BE recommendations, the
Federal Register notice will identify a comment period. The public is
encouraged to submit comments on the draft BE recommendations, and the
agency will consider received comments in developing final BE
recommendations. FDA adopted this process as a means to develop and
disseminate product-specific BE recommendations and provide an
opportunity for the public to consider and comment on those
recommendations.
In the Federal Register of May 31, 2007 (72 FR 30388), FDA
announced the availability of a draft version of this guidance entitled
``Bioequivalence Recommendations for Specific
[[Page 33312]]
Products.'' The May 2007 draft guidance gave interested persons an
opportunity to submit comments through August 29, 2007. The agency is
finalizing the guidance after considering comments received on the
draft guidance. Minor changes were made to the draft guidance to update
FDA Web site information.
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 a new process for making available to
sponsors FDA guidance on how to design product-specific bioequivalence
studies to support ANDAs. 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) either electronic or written comments regarding the
guidance. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: June 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14036 Filed 6-10-10; 8:45 am]
BILLING CODE 4160-01-S