[Federal Register Volume 62, Number 180 (Wednesday, September 17, 1997)]
[Rules and Regulations]
[Pages 48756-48757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24582]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Office of the 
Commissioner

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the general 
redelegations of authority from the Commissioner of Food and Drugs (the 
Commissioner) to other officers of FDA. The amendment delegates to the 
Deputy Commissioner for Policy and the Associate Commissioner for 
Policy Coordination authority to certify that a proposed or final rule, 
if issued, will not have a significant economic impact on a substantial 
number of small entities. Furthermore, the Deputy Commissioner for 
Policy has redelegated the aformentioned authority to certain FDA 
officials authorized to issue Federal Register documents. These actions 
are necessary to ensure the accuracy of the regulations.

EFFECTIVE DATE:  June 25, 1997.

FOR FURTHER INFORMATION CONTACT:
    Edwin V. Dutra, Regulations Policy and Management Staff (HF-26), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-3480, or
    Loretta W. Davis, Division of Management Systems and Policy (HFA-
340), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-4809.

SUPPLEMENTARY INFORMATION: FDA is amending its delegations of authority 
regulations by revising 21 CFR 5.20 and by adding Sec. 5.100 to reflect 
additional authorities under the Regulatory Flexibility Act (5 U.S.C. 
605(b)). On

[[Page 48757]]

November 8, 1996, the Commissioner delegated to the Deputy Commissioner 
for Policy and the Associate Commissioner for Policy Coordination his 
authority, as head of the agency under the Regulatory Flexibility Act 
(5 U.S.C. 605(b)), to certify that a proposed or final rule, if issued, 
will not have a significant economic impact on a substantial number of 
small entities. The Commissioner authorized the Deputy Commissioner for 
Policy and the Associate Commissioner for Policy Coordination to 
redelegate this authority.
    Moreover, in a memorandum dated June 25, 1997, the Deputy 
Commissioner for Policy redelegated to certain FDA officials authorized 
to issue Federal Register documents the authority to make a 
certification under 5 U.S.C. 605(b) for any notice of proposed 
rulemaking and for any final rule that such official is authorized to 
issue. Authority delegated to a position by title may be exercised by a 
person officially designated to serve in such position in an acting 
capacity or on a temporary basis.

List of Subjects in 21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
5 is amended as follows:

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

     1. The authority citation for 21 CFR part 5 continues to read as 
follows:

    Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; 
secs. 301, 302, 303, 307, 310, 311, 351, 352, 361, 362, 1701-1706, 
2101 of the Public Health Service Act (42 U.S.C. 241, 242, 242a, 
242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1); 42 
U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11490, 11921, 
and 12591.
    2. Section 5.20 is amended by adding paragraph (f)(4) to read as 
follows:


Sec. 5.20  General redelegations of authority from the Commissioner to 
other officers of the Food and Drug Administration.

    (f) * * *
    (4) The Deputy Commissioner for Policy and the Associate 
Commissioner for Policy Coordination are authorized under the 
Regulatory Flexibility Act (5 U.S.C. 605(b)) to certify that a proposed 
or final rule, if issued, will not have a significant economic impact 
on a substantial number of small entities. The delegation excludes the 
authority to submit reports to Congress.
 * * * * *
    3. Section 5.100 is added to subpart C to read as follows:


Sec. 5.100  Officials authorized to make certification under 5 U.S.C. 
605(b) for any proposed and final rules.

    The following officials are authorized to perform all the functions 
of the Commissioner of Food and Drugs with regard to decisions made 
under the Regulatory Flexibility Act (5 U.S.C. 605(b)), to certify that 
a proposed or final rule, if issued, will not have a significant 
economic impact on a substantial number of small entities:
     (a) The Associate Commissioner for Regulatory Affairs (ACRA).
     (b) The Director, Center for Biologics Evaluation and Research 
(CBER).
     (c) The Director, Center for Drug Evaluation and Research (CDER).
     (d) The Director, Center for Devices and Radiological Health 
(CDRH).
     (e) The Director, Center for Food Safety and Applied Nutrition 
(CFSAN).
     (f) The Director, Center for Veterinary Medicine (CVM).
     (g) Other FDA Officials Authorized to Issue Federal Register 
Documents.

    Dated: September 9, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-24582 Filed 9-16-97; 8:45 am]
BILLING CODE 4160-01-F