Regulations Review Program Under Executive Order 12866

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