[Federal Register Volume 66, Number 54 (Tuesday, March 20, 2001)]
[Notices]
[Pages 15726-15727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6775]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0049]
Guidance on Reduction of Civil Money Penalties for Small
Entities; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing the final
guidance entitled ``Reduction of Civil Money Penalties for Small
Entities'' as required by the Small Business Regulatory Enforcement
Fairness Act of 1996 (SBREFA) and the Presidential Memorandum of April
21, 1995.
DATES: The final guidance is effective April 19, 2001. Written comments
may be submitted at any time.
ADDRESSES: Submit written comments on the final guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with
the docket number found in brackets in the heading of this document.
Submit written requests for single copies of the final guidance to the
Division of Compliance Policy (HFC-230), Office of Regulatory Affairs,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
or fax your request to 301-827-0482. See the SUPPLEMENTARY INFORMATION
section for electronic access to the final guidance.
FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of
Compliance Policy (HFC-230), Office of Regulatory Affairs, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
0411, FAX 301-827-0482.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing a final guidance for the reduction of civil money
penalties (CMP's) for small entities (penalty reduction guidance) as
mandated by SBREFA (Public Law 104-121) and the Presidential Memorandum
of April 21, 1995 (60 FR 20621, April 26, 1995). SBREFA was enacted on
March 29, 1996, and seeks to improve the regulatory climate for small
entities by, among other things, requiring agencies to establish small
entity penalty reduction policies. The Presidential Memorandum of April
21, 1995, directs agencies to use their discretion to
[[Page 15727]]
modify the penalties for small businesses in certain situations.
FDA currently enforces the following amendments to the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.) and the Public Health Service
Act (42 U.S.C.), which authorize CMP's under the referenced sections:
Radiation Control for Health and Safety Act of 1968 (21 U.S.C.
360pp),
Safe Medical Devices Act of 1990 (21 U.S.C. 333(f)),
Mammography Quality Standards Act of 1992 and the Mammography
Quality Standards Reauthorization Act of 1998 (42 U.S.C. 263b(h)),
National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 262(d)(2)
and 42 U.S.C. 300aa-28),
Prescription Drug Marketing Act of 1988 (21 U.S.C. 333(b)),
Generic Drug Enforcement Act of 1992 (21 U.S.C. 335b), and
Food Quality Protection Act of 1996 (21 U.S.C. 333(f)).
In the Federal Registers of May 18 and June 15, 1999 (64 FR 26984
and 32059, respectively), FDA issued a draft civil money penalty
reduction policy for small entities. One trade association submitted
comments to the docket. FDA reviewed and evaluated all of the comments
and, in response, made appropriate changes to the final penalty
reduction guidance.
In addition to the comments, SBREFA, and the April 21, 1995,
Presidential memorandum discussed above, FDA has reviewed: (1) The
Federal statutes it enforces which authorize CMP's, and (2) its current
practices used to assess CMP's on small entities. On the basis of that
review, FDA is announcing its final penalty reduction guidance for
small entities.
II. Statutory and Regulatory Requirements
This penalty reduction guidance shall not supersede or negate any
applicable statutory or regulatory requirements. For example in device
and food cases, in determining the amount of a CMP and any
modification, the agency shall comply with 21 U.S.C. 333(f).
Subsequently, this penalty reduction guidance would then be applied to
small entities.
III. Significance of Guidance
This guidance document represents the agency's current thinking on
the reduction of CMP's for small entities. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
The agency has adopted good guidance practices (GGP's), which set
forth the agency's regulation for the development, issuance, and use of
guidance documents (65 FR 56468, September 19, 2000). This final
guidance document is issued as a Level 1 guidance consistent with
GGP's.
IV. Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the final
guidance document entitled ``Reduction of Civil Money Penalties for
Small Entities.'' 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. Such comments will be considered when determining
whether to amend the current guidance. Copies of the final guidance and
received comments may be seen in the Dockets Management Branch between
9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
A copy of the final guidance may also be downloaded to a personal
computer with access to the Internet. The Office of Regulatory Affairs'
(ORA) home page includes the guidance and may be accessed at http://www.fda.gov/ora. The final guidance is available under ``Compliance
References.''
Dated: February 22, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-6775 Filed 3-19-01; 8:45 am]
BILLING CODE 4160-01-F