[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]
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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.
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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
