Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability, 82311-82312 [2011-33573]
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Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
supplemental biologics license
application 125320/28 for XGEVA
(denosumab) injection, application
submitted by Amgen Inc. The proposed
indication (use) for this product is for
the treatment of men with castrateresistant prostate cancer at high risk of
developing bone metastases, or spread
of cancer to the bones.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before January 25, 2012.
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allotted for each presentation may be
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requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
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the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
January 18, 2012.
Persons attending FDA’s advisory
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Agency is not responsible for providing
access to electrical outlets.
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Jkt 226001
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33548 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0247]
Food and Drug Administration
Transparency Initiative: Food and Drug
Administration Report on Good
Guidance Practices: Improving
Efficiency and Transparency;
Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments.
ACTION:
As part of the Transparency
Initiative, the Food and Drug
Administration (FDA or Agency) is
announcing the availability of a report
entitled ‘‘Food and Drug Administration
Report on Good Guidance Practices:
Improving Efficiency and
Transparency.’’ This report was
prepared in response to Action Item 11
in the Phase III Report (FDA
Transparency Initiative: Improving
Transparency to Regulated Industry,
dated January 2011). In that action item,
the Commissioner of Food and Drugs
(the Commissioner), Dr. Margaret A.
Hamburg, called for a cross-Agency
working group to prepare a report
identifying FDA’s ‘‘best practices’’ and
making recommendations to streamline
the development of guidance
documents, reduce the time between
issuing draft and final guidance
documents, and make it easier to find
guidance documents on FDA’s Web site.
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
82311
Submit either electronic or
written comments by February 28, 2012.
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 brackets at the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Lisa
M. Dwyer, Office of Policy, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4228, Silver Spring,
MD 20993, (301) 796–4820, FAX: (301)
847–8616, lisa.dwyer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
On January 21, 2009, President
Obama issued a memorandum urging
the heads of executive departments and
Agencies to create an ‘‘unprecedented
level of openness’’ to ‘‘strengthen our
democracy and promote efficiency and
effectiveness’’ (see Memorandum to
Heads of Executive Departments and
Agencies on Transparency and Open
Government, January 21, 2009, (74 FR
4685, January 26, 2009)). In response,
the following June FDA launched its
Transparency Initiative. Information on
the FDA Transparency Initiative is
available at https://www.fda.gov/
AboutFDA/Transparency/Transparency
Initiative/default.htm.
As part of this initiative, FDA issued
the Phase III Report (FDA Transparency
Initiative: Improving Transparency to
Regulated Industry, dated January 2011)
in January 2011. The Phase III Report
contained 19 action items and 5 draft
proposals to make FDA’s operations and
decisionmaking processes more
transparent and to foster more efficient
and cost-effective regulatory processes.
In Action Item 11 of the Phase III
Report, the Commissioner called for a
cross-Agency working group to prepare
a report identifying FDA’s ‘‘best
practices’’ and making
recommendations to: (1) Streamline the
development of guidance documents,
(2) reduce the time between issuing
draft and final guidance documents, and
(3) make it easier to find guidance
documents on FDA’s Web site.
In response to that action item, a
cross-Agency working group under the
leadership of the Office of Policy in the
Office of the Commissioner prepared a
report entitled ‘‘Food and Drug
Administration Report on Good
Guidance Practices: Improving
Efficiency and Transparency’’ (GGP
E:\FR\FM\30DEN1.SGM
30DEN1
srobinson on DSK4SPTVN1PROD with NOTICES
82312
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
Report). The GGP Report identifies
current ‘‘best practices’’ and
recommends strategies to make the
Agency’s guidance processes more
efficient and transparent. The crossAgency working group submitted the
GGP Report to the Commissioner on
September 30, 2011.
These ‘‘best practices’’ and strategies
are critical to the Agency because
developing and issuing guidance
documents is an enormous undertaking
and one that is critical to fulfilling
FDA’s mission. In fiscal year (FY) 2009,
the Agency issued approximately 124
guidance documents. Since that time, its
issuance of guidance documents has
been trending upward, with the Agency
issuing approximately 133 guidance
documents in FY 2010 and
approximately 144 guidance documents
in FY 2011. These numbers include
draft and final Level 1 guidance
documents and Level 2 guidance
documents.
Guidance documents are prepared for
FDA staff, the regulated industry, and/
or the public and describe the Agency’s
interpretation of or policy on a
regulatory issue (§ 10.115(b) (21 CFR
10.115(b)). Unlike statutes and
regulations, guidance documents do not
establish legally enforceable rights or
responsibilities (§ 10.115(d)). There are
two types of guidance documents: Level
1 and Level 2. Level 1 guidance
documents are those that: (1) Set forth
initial interpretations of statutory or
regulatory requirements, (2) set forth
changes in interpretation or policy that
are of more than a minor nature, (3)
include complex scientific issues, or (4)
cover highly controversial issues
(§ 10.115(c)). In contrast, Level 2
guidance documents set forth existing
practices or minor changes in
interpretation or policy. Level 2
guidance documents include all
guidance documents that are not
classified as Level 1 (see id.).
FDA’s Good Guidance Practices
regulation (§ 10.115) governs the
development and issuance of guidance
documents, and it gives interested
persons a number of opportunities to
provide input into the guidance
document development process.
Generally, FDA solicits public input on
Level 1 guidance documents before
implementation. The Agency posts draft
Level 1 guidance documents on its Web
site, and it publicizes them by issuing
a Notice of Availability (NOA) in the
Federal Register. Generally, the Agency
accepts public comments on the
guidance document for 60 days. In some
instances, FDA may also hold public
meetings or workshops on draft Level 1
guidance documents to solicit
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
additional comments, or present the
draft Level 1 guidance document to an
advisory committee for review. Once the
comment period has closed, the Agency
reviews the comments and considers
them as it prepares the final guidance
document. The Agency also posts final
Level 1 guidance documents on its Web
site and publicizes them by issuing an
NOA in the Federal Register.
Generally, FDA does not solicit public
input on Level 2 guidance documents or
on Level 1 guidance documents ‘‘for
immediate implementation’’ (i.e., Level
1 guidance documents for which ‘‘prior
public participation is not feasible or
appropriate,’’ § 10.115(g)(2)) before
implementing the guidance document.
However, FDA publishes an NOA in the
Federal Register for Level 1 guidance
‘‘for immediate implementation’’ and
posts both types of guidance documents
on its Web site, and interested persons
may comment on them at any time after
they have been issued. FDA will review
the comments and revise the guidance
documents, as appropriate. This
streamlined approach permits FDA to
issue Level 1 guidance documents ‘‘for
immediate implementation’’ and Level 2
guidance documents more expeditiously
than standard Level 1 guidance
documents, while still providing
stakeholders with an opportunity to
comment. Importantly, the additional
administrative steps required for
standard Level 1 guidance documents
(i.e., issuing a draft guidance document,
providing a comment period, and
issuing a final guidance document)
generally make the issuance of standard
Level 1 guidance documents a longer
process.
In addition to the opportunity to
comment on guidance documents
themselves, interested persons have
opportunities to provide input to FDA
on topics for guidance documents. FDA
publishes an annual guidance agenda,
listing possible topics for future
guidance document development or
revision during the next year. FDA’s
most recent guidance agenda may be
found in the Federal Register (75 FR
76011, December 7, 2010) online at
https://edocket.access.gpo.gov/2010/pdf/
2010-30623.pdf. Interested persons may
submit comments on the topics on the
list or comments that suggest additional
topics for guidance. Interested persons
also may identify issues in citizen
petitions that the Agency may decide to
address by issuing a guidance
document. (The procedures for filing
citizen petitions are in 21 CFR 10.30.)
Requests for guidance documents also
come to FDA informally. Frequently,
interested persons identify issues that
would benefit from guidance at advisory
PO 00000
Frm 00045
Fmt 4703
Sfmt 9990
committee meetings, industry meetings,
roundtables, and listening sessions or by
contacting the appropriate FDA office.
Interested persons sometimes submit a
proposed draft guidance document to
FDA. Submitting proposed draft
guidance documents, rather than
guidance topics, enables FDA to
approach a guidance topic with a better
understanding of the issues that interest
the stakeholder. This may expedite the
guidance document development
process, particularly if the topic
involves novel scientific issues. FDA
solicits proposed draft guidance at a
variety of different venues, such as trade
association meetings and on the FDA
Web site. Interested persons may submit
proposed draft guidance documents on
unsolicited topics as well.
All guidance topic suggestions and
proposed draft guidance documents are
taken into consideration, but resource
limitations may prevent us from
responding to each suggestion. In
addition, resource limitations often
prevent the Agency from taking action
on the suggestions, as may legal
constraints and policy considerations.
The Commissioner is issuing the GGP
Report to the public to make the
Agency’s processes regarding guidance
document development and issuance
more transparent and to solicit public
comment on the report and
recommendations. The Agency looks
forward to engaging with its
stakeholders as it continues to seek
opportunities to enhance the efficiency
and transparency of the guidance
document development process.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
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 GGP Report at either
https://www.fda.gov/downloads/
AboutFDA/Transparency/
TransparencyInitiative/UCM285124.pdf
or https://www.regulations.gov.
Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33573 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\30DEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82311-82312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33573]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0247]
Food and Drug Administration Transparency Initiative: Food and
Drug Administration Report on Good Guidance Practices: Improving
Efficiency and Transparency; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; request for comments.
-----------------------------------------------------------------------
SUMMARY: As part of the Transparency Initiative, the Food and Drug
Administration (FDA or Agency) is announcing the availability of a
report entitled ``Food and Drug Administration Report on Good Guidance
Practices: Improving Efficiency and Transparency.'' This report was
prepared in response to Action Item 11 in the Phase III Report (FDA
Transparency Initiative: Improving Transparency to Regulated Industry,
dated January 2011). In that action item, the Commissioner of Food and
Drugs (the Commissioner), Dr. Margaret A. Hamburg, called for a cross-
Agency working group to prepare a report identifying FDA's ``best
practices'' and making recommendations to streamline the development of
guidance documents, reduce the time between issuing draft and final
guidance documents, and make it easier to find guidance documents on
FDA's Web site.
DATES: Submit either electronic or written comments by February 28,
2012.
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 brackets at the heading of this document.
FOR FURTHER INFORMATION CONTACT: Lisa M. Dwyer, Office of Policy,
Office of the Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 4228, Silver Spring, MD 20993, (301) 796-
4820, FAX: (301) 847-8616, lisa.dwyer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On January 21, 2009, President Obama issued a memorandum urging the
heads of executive departments and Agencies to create an
``unprecedented level of openness'' to ``strengthen our democracy and
promote efficiency and effectiveness'' (see Memorandum to Heads of
Executive Departments and Agencies on Transparency and Open Government,
January 21, 2009, (74 FR 4685, January 26, 2009)). In response, the
following June FDA launched its Transparency Initiative. Information on
the FDA Transparency Initiative is available at https://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm.
As part of this initiative, FDA issued the Phase III Report (FDA
Transparency Initiative: Improving Transparency to Regulated Industry,
dated January 2011) in January 2011. The Phase III Report contained 19
action items and 5 draft proposals to make FDA's operations and
decisionmaking processes more transparent and to foster more efficient
and cost-effective regulatory processes. In Action Item 11 of the Phase
III Report, the Commissioner called for a cross-Agency working group to
prepare a report identifying FDA's ``best practices'' and making
recommendations to: (1) Streamline the development of guidance
documents, (2) reduce the time between issuing draft and final guidance
documents, and (3) make it easier to find guidance documents on FDA's
Web site.
In response to that action item, a cross-Agency working group under
the leadership of the Office of Policy in the Office of the
Commissioner prepared a report entitled ``Food and Drug Administration
Report on Good Guidance Practices: Improving Efficiency and
Transparency'' (GGP
[[Page 82312]]
Report). The GGP Report identifies current ``best practices'' and
recommends strategies to make the Agency's guidance processes more
efficient and transparent. The cross-Agency working group submitted the
GGP Report to the Commissioner on September 30, 2011.
These ``best practices'' and strategies are critical to the Agency
because developing and issuing guidance documents is an enormous
undertaking and one that is critical to fulfilling FDA's mission. In
fiscal year (FY) 2009, the Agency issued approximately 124 guidance
documents. Since that time, its issuance of guidance documents has been
trending upward, with the Agency issuing approximately 133 guidance
documents in FY 2010 and approximately 144 guidance documents in FY
2011. These numbers include draft and final Level 1 guidance documents
and Level 2 guidance documents.
Guidance documents are prepared for FDA staff, the regulated
industry, and/or the public and describe the Agency's interpretation of
or policy on a regulatory issue (Sec. 10.115(b) (21 CFR 10.115(b)).
Unlike statutes and regulations, guidance documents do not establish
legally enforceable rights or responsibilities (Sec. 10.115(d)). There
are two types of guidance documents: Level 1 and Level 2. Level 1
guidance documents are those that: (1) Set forth initial
interpretations of statutory or regulatory requirements, (2) set forth
changes in interpretation or policy that are of more than a minor
nature, (3) include complex scientific issues, or (4) cover highly
controversial issues (Sec. 10.115(c)). In contrast, Level 2 guidance
documents set forth existing practices or minor changes in
interpretation or policy. Level 2 guidance documents include all
guidance documents that are not classified as Level 1 (see id.).
FDA's Good Guidance Practices regulation (Sec. 10.115) governs the
development and issuance of guidance documents, and it gives interested
persons a number of opportunities to provide input into the guidance
document development process. Generally, FDA solicits public input on
Level 1 guidance documents before implementation. The Agency posts
draft Level 1 guidance documents on its Web site, and it publicizes
them by issuing a Notice of Availability (NOA) in the Federal Register.
Generally, the Agency accepts public comments on the guidance document
for 60 days. In some instances, FDA may also hold public meetings or
workshops on draft Level 1 guidance documents to solicit additional
comments, or present the draft Level 1 guidance document to an advisory
committee for review. Once the comment period has closed, the Agency
reviews the comments and considers them as it prepares the final
guidance document. The Agency also posts final Level 1 guidance
documents on its Web site and publicizes them by issuing an NOA in the
Federal Register.
Generally, FDA does not solicit public input on Level 2 guidance
documents or on Level 1 guidance documents ``for immediate
implementation'' (i.e., Level 1 guidance documents for which ``prior
public participation is not feasible or appropriate,'' Sec.
10.115(g)(2)) before implementing the guidance document. However, FDA
publishes an NOA in the Federal Register for Level 1 guidance ``for
immediate implementation'' and posts both types of guidance documents
on its Web site, and interested persons may comment on them at any time
after they have been issued. FDA will review the comments and revise
the guidance documents, as appropriate. This streamlined approach
permits FDA to issue Level 1 guidance documents ``for immediate
implementation'' and Level 2 guidance documents more expeditiously than
standard Level 1 guidance documents, while still providing stakeholders
with an opportunity to comment. Importantly, the additional
administrative steps required for standard Level 1 guidance documents
(i.e., issuing a draft guidance document, providing a comment period,
and issuing a final guidance document) generally make the issuance of
standard Level 1 guidance documents a longer process.
In addition to the opportunity to comment on guidance documents
themselves, interested persons have opportunities to provide input to
FDA on topics for guidance documents. FDA publishes an annual guidance
agenda, listing possible topics for future guidance document
development or revision during the next year. FDA's most recent
guidance agenda may be found in the Federal Register (75 FR 76011,
December 7, 2010) online at https://edocket.access.gpo.gov/2010/pdf/2010-30623.pdf. Interested persons may submit comments on the topics on
the list or comments that suggest additional topics for guidance.
Interested persons also may identify issues in citizen petitions that
the Agency may decide to address by issuing a guidance document. (The
procedures for filing citizen petitions are in 21 CFR 10.30.)
Requests for guidance documents also come to FDA informally.
Frequently, interested persons identify issues that would benefit from
guidance at advisory committee meetings, industry meetings,
roundtables, and listening sessions or by contacting the appropriate
FDA office. Interested persons sometimes submit a proposed draft
guidance document to FDA. Submitting proposed draft guidance documents,
rather than guidance topics, enables FDA to approach a guidance topic
with a better understanding of the issues that interest the
stakeholder. This may expedite the guidance document development
process, particularly if the topic involves novel scientific issues.
FDA solicits proposed draft guidance at a variety of different venues,
such as trade association meetings and on the FDA Web site. Interested
persons may submit proposed draft guidance documents on unsolicited
topics as well.
All guidance topic suggestions and proposed draft guidance
documents are taken into consideration, but resource limitations may
prevent us from responding to each suggestion. In addition, resource
limitations often prevent the Agency from taking action on the
suggestions, as may legal constraints and policy considerations.
The Commissioner is issuing the GGP Report to the public to make
the Agency's processes regarding guidance document development and
issuance more transparent and to solicit public comment on the report
and recommendations. The Agency looks forward to engaging with its
stakeholders as it continues to seek opportunities to enhance the
efficiency and transparency of the guidance document development
process.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of 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 GGP Report at
either https://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM285124.pdf or https://www.regulations.gov.
Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33573 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P
