[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1162]


[[Page Unknown]]

[Federal Register: January 20, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Ch. I

[Docket No. 94N-0002]

 

Regulations Review Program Under Executive Order 12866

AGENCY: Food and Drug Administration, HHS.

ACTION: Plan for periodic review.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its plan 
to review significant regulations pursuant to Executive Order 12866, 
which requires all Federal agencies to develop a program for 
periodically reviewing existing significant regulations. Under this 
program, the agency will determine whether its regulations need to be 
refined to achieve their public health goals more effectively or to 
avoid unnecessary burdens.

DATES: Written comments by May 20, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Edwin V. Dutra, Jr., Regulations 
Policy and Management Staff (HF-26), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-3480.

SUPPLEMENTARY INFORMATION: Under section 5 of Executive Order 12866, 
each Federal agency must submit a plan to the Office of Management and 
Budget's Office of Information and Regulatory Affairs (OIRA) for 
periodically reviewing its existing significant regulations. The goal 
is for agencies to determine whether existing significant regulations 
should be modified or eliminated to reduce their regulatory burden, to 
make the agency's regulatory program more effective, or to bring them 
into greater alignment with the President's priorities and the 
principles set forth in the Executive Order. The Department of Health 
and Human Services has submitted a plan to OIRA, and this notice is 
being published as part of that plan.
    Over the past 12 years, FDA has completed formal reviews of many of 
its important existing regulations. These reviews were similar to those 
required by Executive Order 12866. For example, the reviews identified 
requirements that were unjustified or unnecessary as a result of 
changed circumstances. The reviews eliminated those requirements, 
thereby reducing the regulatory burden. Each review also eliminated 
duplicative regulations where possible. Reviews have been completed for 
the following nine regulatory areas.
    (1) Antibiotic Certification, 1982 (47 FR 39155, September 7, 
1982): This final rule amended the antibiotic drug and new animal drug 
regulations to exempt all classes of antibiotic drugs from batch 
certification requirements, and amended the medical device regulations 
to exempt antibiotic susceptibility devices from batch certification. 
Under the exemptions, manufacturers are not required to obtain 
premarketing certification of each batch of antibiotic drug or 
antibiotic susceptibility device.
    (2) New Drug Application Procedural Rules (the NDA Rewrite), 1985 
(50 FR 7452, February 22, 1985): FDA revised its regulations governing 
the approval for marketing of new drugs and antibiotic drugs for human 
use. The revisions were intended to expedite the availability of 
beneficial drugs to consumers by improving the efficiency of FDA's 
approval process for new drugs and antibiotic drugs and to help 
applicants prepare and submit higher quality applications, thereby 
permitting FDA to review them more efficiently and with fewer delays.
    (3) Rewrite of Blood Labeling Requirements, 1985 (50 FR 35458, 
August 30, 1985): FDA revised its regulations for blood labeling to 
simplify the requirements for transfusible blood and blood component 
products that are collected or manufactured in a blood bank 
establishment and to unify these requirements.
    (4) Investigational New Drug Application Procedural Rules, 1987 (52 
FR 8798, March 19, 1982): FDA revised its regulations governing the 
submission and review of investigational new drug applications (IND's). 
This action, along with the NDA Rewrite in 1985, was an effort to 
improve the agency's drug approval process. The revised regulations 
ensure FDA's ability to monitor investigations, while also facilitating 
the development of new beneficial drug therapies, and help sponsors of 
clinical investigations prepare and submit high-quality IND's and 
permit FDA to review them efficiently with minimal delay.
    (5) Rewrite of Additional Standards for Reagent Red Blood Cells, 
1987 (52 FR 37446, October 7, 1987): FDA revised the standards for 
reagent red blood cells to make them more flexible and to reflect 
current experience and scientific knowledge.
    (6) Rewrite of Additional Standards for Blood Grouping Reagents, 
1988 (53 FR 12760, April 19, 1988): FDA revised the standards for blood 
grouping reagents to make them more flexible and to reflect current 
experience and scientific knowledge.
    (7) Methadone, 1989 (54 FR 8954, March 2, 1989): The conditions for 
use of methadone in the maintenance and detoxification treatment of 
narcotic addicts are provided in 21 CFR part 291 (the methadone 
regulation). The revisions to the methadone regulation were designed to 
streamline the regulation, to delete the requirement that treatment 
programs using methadone submit annual reports to FDA, and to promote 
more efficient operation of narcotic treatment programs. The rule also 
provided standards for long-term detoxification, as required by the 
Alcohol Abuse, Drug Abuse, and Mental Health Amendments of 1984 (Pub. 
L. 98-509), which revised the statutorily defined length of 
detoxification treatment from 21 days to 180 days.
    (8) X-ray Standards, 1993 (58 FR 26386, May 3, 1993): A final rule 
was issued that simplified, clarified, and updated the original 
standard. These changes reflected the current technology.
    (9) Food Labeling, 1993 (58 FR 2066 et seq., January 6, 1993): 
Beginning in 1989, and ultimately in response to the Nutrition Labeling 
and Education Act of 1990, FDA conducted a comprehensive review of the 
food label, including such issues as nutrition labeling, nutrient 
content claims for sodium, fat, cholesterol, and calories, and health 
claims. As part of this review, it considered the adequacy of its 
regulations implementing six misbranding sections of the act as well as 
its regulation on quantity of contents claims.
    Due to limited resources, FDA prioritizes its reviews based on the 
following criteria: (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. Cumulatively, the reviews listed 
above cover a significant majority of FDA's important regulations.
    FDA's regulatory review program under Executive Order 12866 is as 
follows:

I. FDA-Initiated Review of Existing Regulations

    FDA will continue the practice of reviewing its regulations on a 
continuing basis. These reviews are conducted on either an informal or 
a more formal basis. Informal reviews occur whenever FDA revises an 
existing regulation. The agency reviews the specific regulation being 
modified consistent with Executive Order 12866 to determine if it is 
still valid, and whether it should be updated based on current policy, 
data, and technology.
    More formal reviews are undertaken consistent with available 
resources and regulatory priorities when FDA believes that changed 
circumstances create an opportunity to improve the effectiveness and 
efficiency of existing regulations or to reduce regulatory burden. 
Examples are listed above. FDA is currently conducting such reviews of 
regulations in the following areas:
    (1) Medical Devices; Recordkeeping and Reporting for Electronic 
Products
    (2) Medical Devices; Current Good Manufacturing Practice
    (3) Hearing Aids
    (4) Investigational New Animal Drug Applications Procedural Rules
    (5) New Animal Drug Application (NADA) Procedural Rules
    (6) NADA Records and Reports.
    In addition, FDA's Center for Biologics Evaluation and Research 
(CBER) is in the process of establishing two task forces to perform 
reviews of all blood regulations and administrative and licensing 
regulations. CBER will conduct these reviews based on standards that 
incorporate the elements of Executive Order 12866.
    FDA invites public comment on other regulations that warrant review 
and possible revision to more effectively achieve the agency's public 
health and regulatory objectives, reduce burdens on regulated 
industries and other affected parties, or better conform to the 
priorities and principles set forth in Executive Order 12866. 
Suggestions should be accompanied by specific examples of regulations 
that need to be reviewed, the improvement to be achieved, and the 
criteria contained in the Executive Order 12866 under which such a 
review should be focused.
    Executive order 12866 requires agencies to identify any legislative 
mandates that require the agency to impose regulations that the agency 
believes are unnecessary or outdated by reason of changed 
circumstances. FDA invites public comment on this issue.

II. FDA Reduction of Backlog of Pending Proposed Regulations

    As part of FDA's regulations streamlining initiative begun in 1991, 
the agency instituted an annual review of outstanding advance notices 
of proposed rulemaking, notices of proposed rulemaking, and other 
notices concerning proposed actions that had not been made final. In 
the Federal Register of December 30, 1991, the agency withdrew 89 
outstanding proposals, and elsewhere in this issue FDA is withdrawing 
an additional 9 proposals. When the annual review identifies proposed 
rules as outdated, no longer necessary, or, based on agency priorities, 
unlikely to be completed in the foreseable future, FDA will publish a 
notice of intent to withdraw those proposals in the Federal Register. 
FDA will continue this periodic review to help the agency, regulated 
industries, and other affected parties focus more effectively on FDA's 
active rulemaking agenda. The agency invites public comment on other 
proposed actions that could be considered for withdrawal.

III. Citizen Petitions Process

    Under FDA's procedural regulations any interested party may 
petition the agency. The petition process is a mechanism often used by 
industry and the public to request that the agency amend, revoke, or 
create a regulation. FDA encourages the continued use of citizen 
petitions as a means of identifying those FDA regulations which should 
be candidates for review under Executive Order 12866.
    Interested persons may, on or before May 20, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
this notice. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: January 11, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-1162 Filed 1-19-94; 8:45 am]
BILLING CODE 4160-01-F