[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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