[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11162]


[[Page Unknown]]

[Federal Register: May 10, 1994]


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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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