[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Proposed Rules]
[Pages 23520-23522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2011-N-0259]


Periodic Review of Existing Regulations; Retrospective Review 
Under E.O. 13563

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification for request for comment.

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SUMMARY: In accordance with Executive Order 13563, ``Improving 
Regulation and Regulatory Review,'' the Food and Drug Administration 
(FDA) is conducting a review of its existing regulations to determine, 
in part, whether they can be made more effective in light of current 
public health needs and to take advantage of and support advances in 
innovation. The goal of this review of existing regulations, as with 
our other reviews, is to help ensure that FDA's regulatory program is 
more effective and less burdensome in achieving its regulatory 
objectives. FDA is requesting comment and supporting data on which, if 
any, of its existing rules are outmoded, ineffective, insufficient, or 
excessively burdensome and thus may be good candidates to be modified, 
streamlined, expanded, or repealed. As part of this review, FDA also 
invites comment to help us review our framework for periodically 
analyzing existing rules.

DATES: Submit either electronic or written comments by June 27, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0259, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2011-N-0259 for this rulemaking. All comments 
received may

[[Page 23521]]

be posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lisa Helmanis, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3216, 
Silver Spring, MD 20993-0002, 301-796-9135.

SUPPLEMENTARY INFORMATION: On February 2, 2011, President Barack Obama 
issued Executive Order (E.O.) 13563, ``Improving Regulation and 
Regulatory Review.'' One of the provisions in the new Executive order 
is the affirmation of retrospective reviews of existing significant 
regulations. FDA already has several processes in place to ensure 
periodic review of its existing regulations, including those that are 
significant, and will continue to enhance these efforts. Under E.O. 
13563, FDA is reviewing this framework for retrospective review of 
regulations and, through this notice, is soliciting comments on ways to 
make this program more effective.

I. Background

    FDA is responsible for protecting the public health by: (1) 
Ensuring the safety and efficacy of human and veterinary drugs, 
biological products, and medical devices; (2) ensuring the safety and 
security of our nation's food supply, products that emit radiation, 
cosmetics; and (3) regulating the manufacture, marketing, and 
distribution of tobacco products. FDA also promotes the public health 
by striving to foster innovative approaches and solutions for some of 
our nation's most compelling health and medical challenges.
    Currently, FDA has three main mechanisms that trigger a 
retrospective review of an existing regulation. First, a retrospective 
review may occur when there is a significant change in circumstances, 
such as advances in technology, new data or other information, or 
legislative change. Second, whenever FDA is revising an existing 
regulation, it reviews that regulation to determine if the underlying 
science and policy are still valid and whether the regulations should 
be updated based on current science, policy, data, or technology. The 
third mechanism is FDA's Citizen Petition process. Under 21 CFR 10.30, 
FDA provides a mechanism for the public to request the Commissioner of 
Food and Drugs to issue, amend, or revoke a regulation by submitting a 
Citizen Petition.
    Other ongoing mechanisms that FDA uses to target specific audiences 
are biannual letters to State and Local government officials and small 
business entities, which are also posted on FDA's Web site. These 
letters highlight upcoming regulations that FDA believes may have an 
impact on these two groups. In addition, FDA uses the Federal 
Government's biannual Unified Agenda of Federal Regulations (Unified 
Agenda) to announce reviews conducted under section 610(c) of the 
Regulatory Flexibility Act (RFA). In section 610(c), Federal Agencies 
are required within 10 years of the effective date of regulations that 
have a significant economic impact on a substantial number of small 
entities to review the regulation and seek public input on the 
continued need for the regulation or on possible changes to the 
regulation.
    Since the 1980s, FDA has participated in a variety of reviews to 
streamline and improve its regulatory processes. For example, as 
previously mentioned, section 610(c) of the RFA requires Agencies to 
review their regulations to determine whether the rules should be 
continued without change, amended, or rescinded to minimize any 
significant economic impact on a substantial number of small entities. 
These reviews are announced in the Unified Agenda.
    In the 1990s, FDA participated in the ``Reinventing Government'' 
initiative and met 95 percent of its goal for eliminating outdated or 
unnecessary regulations, and 89 percent of its goal for revising 
regulations. Following that initiative, FDA has undertaken other 
reviews of its regulations and regulatory processes including 
implementing new efficiencies such as withdrawing outdated proposed 
rules that were never finalized. The most recent withdrawal was in 2008 
(73 FR 75625, December 12, 2008). We currently conduct this review of 
pending proposed rules about every 5 years.
    Over the past 15 years, there have also been major legislative 
changes that have significantly reformed major program areas within FDA 
and added to the Agency's responsibilities. When FDA develops 
implementing regulations for these legislative mandates, FDA also takes 
the opportunity to modify or revoke related regulations as appropriate, 
and streamline various regulatory processes.
    The Food and Drug Administration Modernization Act of 1997 and, 10 
years later, the Food and Drug Administration Amendments Act of 2007 
(FDAAA) both modernized certain FDA programs and created new ones, 
mandating numerous regulations to implement those programs. FDAAA also 
expanded FDA's user fee authority and charged FDA with encouraging more 
research and development for treatments specifically for children. In 
2009, FDA saw a significant increase in its authorities with enactment 
of the Family Smoking Prevention and Tobacco Control Act of 2009. 
Finally, earlier this year, the FDA Food Safety Modernization Act was 
signed into law by President Obama and, when fully implemented, will 
enable FDA to better protect public health by helping to ensure the 
safety and security of the food supply.

II. Request for Comments

    FDA is first seeking comment on how the Agency could revise its 
existing review framework to meet the objectives of E.O. 13563 
regarding the development of a plan with a defined method and schedule 
for identifying certain significant rules that may be obsolete, 
unnecessary, unjustified, excessively burdensome, or counterproductive. 
Comments should address how best to evaluate and analyze regulations to 
expand on those that work and to modify, improve, or rescind those that 
do not. To be useful, comments should address how FDA can best obtain 
and consider accurate, objective information and data about the costs, 
burdens, and benefits of existing regulations and whether there are 
existing sources of data that FDA can use to evaluate the post-
promulgation effects of regulations over time. FDA is particularly 
interested in how well its current processes for reviewing regulations 
function and how those processes might be expanded or otherwise adapted 
to meet the objectives of E.O. 13563. FDA is further interested in 
comments about factors that it should consider in selecting rules for 
review and prioritizing review.
    Due to limited resources, FDA generally focuses its retrospective 
review efforts on: (1) Regulations that have a significant public 
health impact, (2) regulations that impose a significant burden on the 
Agency and/or industry, and (3) regulations that impose no significant 
burden on the Agency and/or industry. FDA welcomes comments

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on other criteria it should be using when prioritizing its reviews of 
existing significant regulations.
    In addition, FDA is seeking public comment on which, if any, 
regulations should be reviewed at this time. Please identify any 
regulation that should be modified, expanded, streamlined, or repealed 
to make our regulatory program more effective and less burdensome. 
Please be as specific as possible in your comments. To support its 
efforts to support innovation, FDA is particularly interested in 
comments that identify regulations that may be impediments to 
innovation and suggestions for how they can be improved.
    Comments should focus on regulations that have demonstrated 
deficiencies. Comments that reiterate previously submitted arguments 
relating to recently issued rules will be less useful. Furthermore, the 
public should focus on rule changes that will achieve a broad public 
impact, rather than an individual personal or corporate benefit. 
Comments should reference a specific regulation by the Code of Federal 
Regulations (CFR) cite, and provide specific information on what needs 
fixing and why. Lastly, FDA stresses that this review is for published 
final rules; the public should not use this process to submit comments 
on proposed rules.
    The most useful comments will include which specific regulations 
need to be changed, strengthened or clarified, or revoked. It will be 
most helpful to include the specific reasons explaining why the change 
or revocation is necessary or desired, and to provide specific ways to 
improve the regulation, particularly any specific language 
modifications.
    The Agency will be able to more efficiently review and consider 
comments that are submitted in the format shown in table 1 of this 
document:

                 Table 1--Format for Submitting Comments
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           Name of regulation
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Type of Product or FDA Center            ...............................
 Regulating the Product.
Statute or Code of Federal Regulations   ...............................
 cite (if known).
Brief Description of Problem...........  (For example, is it outmoded,
                                          ineffective, insufficient, or
                                          excessively burdensome? Why?)
Available Data on Cost or Economic       (Quantified benefits and cost
 Impact.                                  if possible. Qualitative
                                          description, if needed.)
Proposed Solution......................  (Include the fix and procedure
                                          to solve it. For example, what
                                          would be the best way to
                                          modify, streamline, expand, or
                                          repeal the regulation?)
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    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. 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.

    Dated: April 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10131 Filed 4-26-11; 8:45 am]
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