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Federal Register / Vol. 72, No.

119 / Thursday, June 21, 2007 / Notices 34255

Dated: June 14, 2007. 1115(a)(1) and (2) of the Social Security DATES: Fax written comments on the
Robert Sargis, Act. collection of information by July 23,
Reports Clearance Officer. 4. The authority to approve 2007.
[FR Doc. 07–3049 Filed 6–20–07; 8:45 am] interagency agreements to procure, ADDRESSES: To ensure that comments on
BILLING CODE 4184–01–M provide, or exchange services, supplies, the information collection are received,
or equipment requires the concurrence OMB recommends that written
of the ACF Chief Financial Officer if it comments be faxed to the Office of
DEPARTMENT OF HEALTH AND exceeds $250,000 (including Information and Regulatory Affairs,
HUMAN SERVICES amendments) within a fiscal year or if OMB, Attn: FDA Desk Officer, FAX:
it requires the signature of the Assistant 202–395–6974. All comments should be
Administration for Children and Secretary, ACF, or the Secretary of HHS. identified with the OMB control number
Families 0910–0541. Also include the FDA
(c) Effective Date
docket number found in brackets in the
Statement of Organization, Functions This delegation is effective upon the heading of this document.
and Delegation of Authority date of signature. FOR FURTHER INFORMATION CONTACT:
Notice is hereby given that I have (d) Effect on Existing Delegations Jonna Capezzuto, Office of the Chief
delegated to the Principal Deputy Information Officer (HFA–250), Food
Assistant Secretary, Deputy Assistant As related to this delegation of and Drug Administration, 5600 Fishers
Secretaries, Program Directors, Program authority, this delegation supersedes all Lane, Rockville, MD 20857, 301–827–
Commissioners, Deputy Director/ previous delegations of authority 4659.
Commissioner, Office of Child Support involving the administration of the
SUPPLEMENTARY INFORMATION: In
Enforcement, and Staff Office Directors cross-program authorities delegated
compliance with 44 U.S.C. 3507, FDA
the following authority vested in me by herein.
has submitted the following proposed
the Secretary of Health and Human I hereby ratify and affirm any actions collection of information to OMB for
Services in the memorandum dated taken by the Principal Deputy Assistant review and clearance.
August 20, 1991, Delegations of Secretary, Deputy Assistant Secretaries,
Authority for Social Security Act Program Directors, Program Preparing a Claim of Categorical
Programs; 31 U.S.C. 1535; and HHS Commissioners, Deputy Director/ Exclusion or an Environmental
General Administrative Manual, Commissioner, Office of Child Support Assessment for Submission to the
Chapter 8–77. Enforcement, and Staff Office Directors, Center for Food Safety and Applied
which involved the exercise of the Nutrition (OMB Control Number 0910–
(a) Authorities Delegated authority delegated herein prior to the 0541)—Extension
1. Authority to administer approved effective date of this delegation. As an integral part of its
cooperative research, experimental, Dated: June 13, 2007. decisionmaking process, FDA is
pilot or demonstration projects under Daniel C. Schneider, obligated under the National
the provisions of sections 1110 and Acting Assistant Secretary for Children and Environmental Policy Act of 1969
1115 of the Social Security Act. Families. (NEPA) to consider the environmental
2. Authority to approve interagency [FR Doc. E7–12019 Filed 6–20–07; 8:45 am]
impact of its actions, including allowing
agreements to procure, provide or notifications for food contact substances
BILLING CODE 4184–01–P
exchange services, supplies or to become effective and approving food
equipment. additive petitions, color additive
DEPARTMENT OF HEALTH AND petitions, generally recognized as safe
(b) Limitations affirmation petitions, requests for
HUMAN SERVICES
1. The authority listed in #1 above exemption from regulation as a food
shall be exercised under the condition Food and Drug Administration additive, and actions on certain food
that projects may be administered by the labeling citizen petitions, nutrient
Office of Planning, Research and content claims petitions, and health
[Docket No. 2007N–0091]
Evaluation (OPRE), by the program/staff claims petitions. In 1997, FDA amended
office or jointly by OPRE with the Agency Information Collection its regulations in part 25 (21 CFR part
program/staff office. Activities; Submission for Office of 25) to provide for categorical exclusions
2. Where all or any part of an Management and Budget Review; for additional classes of actions that do
experimental, pilot, demonstration, or Comment Request; Preparing a Claim not individually or cumulatively have a
other project is wholly financed with of Categorical Exclusion or an significant effect on the human
Federal funds made available under Environmental Assessment for environment (62 FR 40570, July 29,
sections 1110 or 1115 of the Social Submission to the Center for Food 1997). As a result of that rulemaking,
Security Act, without any State, local or Safety and Applied Nutrition FDA no longer routinely requires
other non-Federal financial submission of information about the
participation, that project must be AGENCY: Food and Drug Administration, manufacturing and production of FDA-
approved by the Secretary of Health and HHS. regulated articles. FDA also has
Human Services. ACTION: Notice. eliminated the previously required
3. This delegation of authority does Environmental Assessment (EA) and
not include the authority to approve/ SUMMARY: The Food and Drug abbreviated EA formats from the
disapprove projects under section 1115 Administration (FDA) is announcing amended regulations. Instead, FDA has
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of the Social Security Act or approve/ that a proposed collection of provided guidance that contains sample
disapprove waivers of State Plan information has been submitted to the formats to help industry submit a claim
requirements or costs that would not Office of Management and Budget of categorical exclusion or an EA to
otherwise be included as expenditures (OMB) for review and clearance under CFSAN. The guidance document
under the provisions of section the Paperwork Reduction Act of 1995. entitled ‘‘Preparing a Claim of

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34256 Federal Register / Vol. 72, No. 119 / Thursday, June 21, 2007 / Notices

Categorical Exclusion or an submission to CFSAN. The following these approaches satisfy the
Environmental Assessment for questions are covered in this guidance: requirements of the applicable statutes
Submission to the Center for Food (1) What types of industry-initiated and regulations.
Safety and Applied Nutrition’’ actions are subject to a claim of FDA is requesting the extension of
identifies, interprets, and clarifies categorical exclusion? (2) What must a OMB approval for the information
existing requirements imposed by claim of categorical exclusion include collection provisions in the guidance.
statute and regulation, consistent with by regulation? (3) What is an EA? (4)
the Council on Environmental Quality When is an EA required by regulation Description of Respondents: The
regulations (40 CFR 1507.3). It consists and what format should be used? (5) likely respondents include businesses
of recommendations that do not What are extraordinary circumstances? engaged in the manufacture or sale of
themselves create requirements; rather, and (6) What suggestions does CFSAN food, food ingredients, and substances
they are explanatory guidance for FDA’s have for preparing an EA? Although used in materials that come into contact
own procedures in order to ensure full CFSAN encourages industry to use the with food.
compliance with the purposes and EA formats described in the guidance In the Federal Register of March 28,
provisions of NEPA. because standardized documentation 2007 (72 FR 14581), FDA published a
The guidance provides information to submitted by industry increases the 60-day notice requesting public
assist in the preparation of claims of efficiency of the review process, comment on the information collection
categorical exclusion and EAs for alternative approaches may be used if provisions. No comments were received.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per Total Burden
21 CFR Section Respondents per Response Responses Response Hours

25.32(i) 52 3 156 1 156

25.32(o) 1 1 1 1 1

25.32(q) 7 2 14 1 14

Total 171 171


1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimates in table 1 of this believe that collecting this information extension of an existing collection of
document for respondents and numbers should also take no longer than 1 hour information, and to allow 60 days for
of responses are based on the per submission. public comment in response to the
annualized numbers of petitions and Dated: June 14, 2007. notice. This notice solicits comments on
notifications qualifying for § 25.32(i) Jeffrey Shuren, reporting requirements in implementing
and (q) that the agency has received in the lists of U.S. firms/processors
Assistant Commissioner for Policy.
the past 3 years. Please note that, in the exporting shell eggs, dairy products,
past 3 years, there have been no [FR Doc. E7–11969 Filed 6–20–07; 8:45 am]
game meat and game meat products to
submissions that requested an action BILLING CODE 4160–01–S
the European Community (the EC).
that would have been subject to the DATES: Submit written or electronic
categorical exclusion in § 25.32(o). To comments on the collection of
DEPARTMENT OF HEALTH AND
avoid counting this burden as zero, FDA information by August 20, 2007.
HUMAN SERVICES
has estimated the burden for this ADDRESSES: Submit electronic
categorical exclusion at one respondent Food and Drug Administration comments on the collection of
making one submission a year for a total information to: http://www.fda.gov/
of one annual submission. [Docket No. 2007N–0230]
dockets/ecomments. Submit written
To calculate the estimate for the hours
Agency Information Collection comments on the collection of
per response values, we assumed that
Activities; Proposed Collection; information to the Division of Dockets
the information requested in this
Comment Request; Information From Management (HFA–305), Food and Drug
guidance for each of these three
United States Processors That Export Administration, 5630 Fishers Lane, rm.
categorical exclusions is readily
to the European Community 1061, Rockville, MD 20852. All
available to the submitter. For the
comments should be identified with the
information requested for the exclusion AGENCY: Food and Drug Administration, docket number found in brackets in the
in § 25.32(i), we expect that submitter HHS. heading of this document.
will need to gather information from ACTION: Notice.
appropriate persons in the submitter’s FOR FURTHER INFORMATION CONTACT:
company and to prepare this SUMMARY: The Food and Drug Jonna Capezzuto, Office of the Chief
information for attachment to the claim Administration (FDA) is announcing an Information Officer (HFA–250), Food
for categorical exclusion. We believe opportunity for public comment on the and Drug Administration, 5600 Fishers
that this effort should take no longer proposed collection of certain Lane, Rockville, MD 20857, 301–827–
than 1 hour per submission. For the information by the agency. Under the 4659.
jlentini on PROD1PC65 with NOTICES

information requested for the exclusions Paperwork Reduction Act of 1995 (the SUPPLEMENTARY INFORMATION: Under the
in § 25.32(o) and (q), the submitters will PRA), Federal agencies are required to PRA (44 U.S.C. 3501–3520), Federal
almost always merely need to copy publish notice in the Federal Register agencies must obtain approval from the
existing documentation and attach it to concerning each proposed collection of Office of Management and Budget
the claim for categorical exclusion. We information, including each proposed (OMB) for each collection of

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