Regulations Review Plan

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Regulations Review Plan

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is announcing plans to

review its regulations in conjunction with other review initiatives

already announced by the Department of Health and Human Services (HHS)

to implement Executive Order 12866. The NIH review is intended to

determine whether any NIH regulations, including those determined to be

``significant'' by the Office of Management and Budget (OMB), as

defined under E. O. 12866, and those determined to be ``not

significant'' need to be modified to make them more effective, less

burdensome, and more in alignment with the President's priorities and

regulatory principles. NIH invites the submission of data, information,

and ideas by interested individuals and organizations to assist in the

review.

DATES: In order to be considered in the review process, comments must

be received on or before July 11, 1994.

ADDRESSES: Comments should be sent to Jerry Moore, Regulatory Affairs

Officer, Office of Management Assessment, National Institutes of

Health, Building 31, Room 3B11, Bethesda, Maryland 20894.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, Regulatory Affairs

Officer, telephone (301) 496-4606 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: The President issued Executive Order 12866,

``Regulatory Planning and Review,'' on September 30, 1993. The basic

purpose of E. O. 12866 is to make regulations less burdensome, more

effective, and in greater alignment with the President's priorities and

regulatory principles. Section 5 of E.O. 12866 requires that each

agency periodically review its existing significant regulations to

determine whether these regulations should be modified or eliminated so

as to make the agencies' regulatory programs more effective. For the

purposes of E. O. 12866, a ``significant'' regulation means a

regulation that may: (1) Have an annual effect on the economy of $100

million or more or adversely affect in a material way the economy, a

sector of the economy, productivity, competition, jobs, the

environment, public health or safety, or State, local, or tribal

governments or communities; (2) Create serious inconsistency or

otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user

fees, or loan programs or the rights and obligations of recipients

thereof; or (4) Raise novel legal or policy issues arising out of legal

mandates, the President's priorities, or the principles set forth in

Executive Order 12866.

On January 20, 1994, HHS published a notice in the Federal Register

(59 FR 3040) describing its plan for implementing E.O. 12866 and for

continuing its implementation of the Regulatory Flexibility Act, Public

Law 96-354, which requires each agency to review regulations issued by

the agency which will have a significant economic impact on a

substantial number of entities. Among other things, the HHS plan

invites the public, especially those most affected by existing

regulations, to submit data, information, and views to assist HHS in

its review of regulations issued by the Department including those

issued by NIH. NIH will use whatever information is collected by HHS to

help identify what reforms are needed to make those regulations which

are determined by OMB to be ``significant'' more effective and less

burdensome.

Additionally, NIH believes that in the spirit of the President's

efforts to provide a more effective and less burdensome regulatory

system it would be beneficial at this time for NIH to also review those

regulations which may be determined by OMB to be ``not significant.''

Therefore, NIH invites comments from the public, especially from those

most affected by regulations issued by NIH, to help identify

opportunities for making all of NIH regulations more effective and less

burdensome. Comments will be most helpful when they clearly identify

the regulation to which the comment is addressed and specifically

explain why and how the regulation imposes unnecessary or

disproportionately burdensome demands on those regulated. NIH

encourages the submission of information, particularly data concerning

the costs of the regulation, that support the comment. NIH also

encourages the submission of ideas for more actively involving those

most affected by NIH regulations in the planning of regulations before

they are formally proposed in the Federal Register or in future

reviews, including how electronic forums might best be used for the

exchange of information among NIH and affected parties; and the

submission of ideas for improving the clarity of its regulations.

Careful review of regulations can require a significant amount of

time and resources. Therefore, NIH will consider what is practicable

and reasonable, given its current resources and other responsibilities

and comments made in response to this Notice and HHS's previous Notice,

in prioritizing regulations for review, and in establishing long range

schedules for beginning and ending reviews. NIH will issue another

notice summarizing the information that it receives from the HHS notice

concerning ``significant'' regulations issued by NIH and the comments

that it receives from the public concerning regulations determined to

be ``not significant.'' At that time, NIH will also set forth more

detailed plans for pursuing identified opportunities for making its

regulations more effective and less burdensome.

Dated: April 28, 1994.

Ruth L. Kirschstein,

Deputy Director, NIH.

[FR Doc. 94-11162 Filed 5-9-94; 8:45 am]

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