Reinvention of Administrative Procedures Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 2, 3, 5, 10, 12, 20, 56, and 58

[Docket No. 96N-0163]

RIN 0910-AA69

Reinvention of Administrative Procedures Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is considering ways to

further streamline its administrative procedures regulations as a

result of a page-by-page review of the agency's regulations. This

regulatory review is part of the administration's ``Reinventing

Government'' initiative that seeks to streamline Government and to ease

the burden on regulated industry and consumers. FDA is seeking public

comment on ways to streamline its administrative procedures

regulations.

DATES: Written comments by September 3, 1996.

[[Page 28117]]

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Regarding information concerning the regulations: Philip L. Chao,

Policy Development and Coordination Staff (HF-23), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.

Regarding general information on FDA's ``reinventing initiative'':

Lisa M. Helmanis, Regulations Policy Management Staff (HF-26), Food and

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-

3480.

SUPPLEMENTARY INFORMATION: On March 4, 1995, President Clinton

announced plans for reforming the Federal regulatory system as part of

his ``Reinventing Government'' initiative. In his March 4, 1995,

directive, the President ordered all Federal agencies to conduct a

page-by-page review of their regulations and to ``eliminate or revise

those that are outdated or otherwise in need of reform.'' This notice

represents FDA's continuing effort to implement the President's plan.

In previous issues of the Federal Register, FDA proposed revoking or

revising other regulations; the agency expects to issue additional

reinvention proposals in the future.

In this notice, FDA is seeking comments on ways listed in the table

below in which its administrative regulations could be updated or

revised in order to streamline the agency's administrative practices

and procedures.

The following table contains a section-by-section analysis of the

regulations that FDA is considering ``reinventing.'' These regulations

are listed numerically as they appear in the Code of Federal

Regulations (CFR).

Section-by-Section Analysis of Regulations Under Consideration

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Description or

21 CFR Cite Title of Explanation of

Regulation Reinvention

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Sec. 1.3..................... Defines label and Should the

labeling. definitions be

amended? There are

only two definitions

(label and labeling)

involved, but they

could be updated to

be more consistent

with current

statutory language.

Sec. 1.21.................... Describes what This section provides

constitutes a general information

failure to on failures to

reveal a reveal material

material fact. facts. Should this

section be revised,

expanded, or

removed?

Sec. 1.23.................... Describes This provision could

procedures for be rewritten to

requesting a remove extraneous

variance or material and to

exemption from provide better

required label instructions on

statements. procedures for a

variance or

exemption.

Sec. 1.24.................... Lists granted Because much of the

label exemptions text is devoted to

for foods, foods, the provision

animal drugs, could be relocated

and cosmetics. to that part of the

CFR devoted to

foods. Similar moves

could be made for

the paragraphs on

animal drugs and

cosmetics. Would it

be more useful to

move these

provisions to the

corresponding

subject areas?

Sec. 1.90.................... Notice of This section explains

sampling. the procedures for

notification of

sampling of imports.

Should this section

be consolidated with

Sec. 1.91?

Sec. 1.91.................... Payment for This section provides

samples. that FDA will pay

for import samples

of nonviolative

goods.

Sec. 2.125................... Establishes Should this provision

procedures to be modified to

permit the use reflect current

of requirements under

chlorofluorocarb the Clean Air Act

ons (CFC's) in and to correspond

self-pressurized with the

containers. Environmental

Protection Agency

regulations on CFC

use and warning

labels?

Sec. 3.6..................... States who the This section should

product be amended to

jurisdiction reflect the current

officer is. information.

Part 5........................ Delegations of Some of the

authority. delegations of

authority refer to

offices or titles

that no longer exist

or have changed due

to reorganizations.

This part should be

revised to reflect

the most current

information. Does it

remain useful to

codify these

delegations of

authority?

Part 10 subparts A and B...... Administrative These regulations

practices and govern the practices

procedures. and procedures for

petitions, hearings,

and other

administrative

proceedings and

activities conducted

by FDA. Some

sections should be

revised to provide

more flexibility or

efficiency. For

example, could FDA's

citizen petitions

process be made more

efficient?

Part 12....................... Formal Should FDA's

evidentiary regulations

public hearing. governing formal

hearings be

simplified or

clarified?

Part 20....................... Public This part governs

information. FDA's communication

with the public.

Does this part

continue to reflect

the best way for FDA

to handle public

information? Are

there better, more

efficient approaches

that should be

embodied in FDA's

regulations?

Sec. 56.104.................. Describes The first two exempt

exemptions from classes are probably

institutional inapplicable today

review boards because they refer

requirements. to clinical research

begun before July

27, 1981. Should

this section be

amended by removing

paragraphs (a) and

(b)?

Part 58....................... Good laboratory This part describes

practice fundamental

regulations. principles for

laboratories to

observe and are

intended to ensure

the quality and

integrity of safety

data. Updating to

reflect current

technology (such as

greater use of

computers) may be

needed.

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Interested persons may, on or before, September 3, 1996, submit to

the Dockets Management Branch (address above) written comments

regarding this advance notice of proposed rulemaking (ANPRM). 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.

[[Page 28118]]

This ANPRM is issued under section 301 et seq. of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and under the authority

of the Commissioner of Food and Drugs.

Dated: May 28, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96-13980 Filed 6-3-96; 8:45 am]

BILLING CODE 4160-01-F