[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82311-82312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33573]
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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.
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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 http://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, [email protected].
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 http://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 http://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 http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM285124.pdf or http://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]
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