[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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