Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability, 28872-28873 [E6-7528]
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Federal Register / Vol. 71, No. 96 / Thursday, May 18, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: The Office of Community
Services (OCS) Evaluation Initiative.
OMB No.: New Collection.
Description: This questionnaire is part
of a contract that addresses evaluation
strategies for three programs
administered by OCS: Community
Economic Development (CED), Rural
Community Facilities (RF), and Job
Opportunities for Low-Income
Individuals (JOLI). The legislative
requirement for two of these programs,
i.e., the RF and CED programs, is in
Title IV of the Community
Opportunities, Accountability, and
Training and Educational Services Act
(COATS Human Services
Reauthorization Act) of Oct. 27, 1998,
Pub. L. 105–285, sec. 680(b) as
amended. This legislative directive
states that ‘‘The Secretary shall require
all activities receiving assistance under
this section to be evaluated for their
effectiveness. Funding for such
evaluations shall be provided as a stated
percentage of the assistance or through
a separate grant awarded by the
Secretary specifically for the purposes
of evaluation of a particular activity or
group of activities.’’
Under Title V, Section 505, of the
Family Support Act of 1988, Public Law
100–485, sec. 505(f), JOLI was initially
a demonstration program that required
local evaluations of each project. When
JOLI was reauthorized in 1996 (Pub. L.
104–193—Aug. 22, 1996), it no longer
had demonstration status and
evaluation requirements. As a result, a
formal evaluation for the JOLI program
has not been conducted since the 1996
Public Law reauthorization. At this
time, OCS is interested in a formal
evaluation to assess the JOLI program.
OCS has chosen to evaluate all three
of these programs through a separate
contract awarded by the Secretary using
the Office of Management and Budget’s
(OMB) Performance Assessment Rating
Tool (PART) in order to critically review
the overall design and effectiveness of
each program in its totality. The
evaluation initiative contract provides
the central office with the mechanism to
ensure that all programs evaluated will
have consistent data that is in agreement
with the direction of OMB and provides
the Secretary with information on
program efficiency and effectiveness.
The evaluation survey’s primary
purpose is to document and
systematically evaluate the program
performance of these OCS discretionary
grants programs in qualitative and
quantitative terms. Thus it will assess
each of the three OCS discretionary
grants programs—CED, RF and JOLI—
using qualitative and quantitative
evaluation methods that capture key
information about program and granteelevel performance in four general areas:
(1) Program purpose and design; (2)
strategic planning; (3) program
management; and (4) program results.
The evaluation activities will build on
the initial year’s findings and methods,
with the goal of expanding data
collection and analysis to improve the
validity and generalizability of findings.
The questions will be administered
online.
Respondents: Active CED and JOLI
grantees with grants awarded from 2001
through 2004.
ANNUAL BURDEN ESTIMATES
Instruments
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Questionnaire from OCS–CED and JOLI Grantees in the U.S. .....................
172
1
1.5
258
........................
........................
........................
258
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Estimated Total Annual Burden Hours .....................................................
Additional Information: Copies of the
proposed collection may be obtained
from writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB is required to make a decison
concerning the collection of information
between 30 and 760 days after
pubication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30-days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
VerDate Aug<31>2005
18:14 May 17, 2006
Jkt 208001
Dated: May 12, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–4636 Filed 5–17–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D–0379] (formerly Docket
No. 03D–0379)
Guidance for Industry: Preparing a
Claim of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
availability of a guidance document
entitled ‘‘Guidance for Industry:
Preparing a Claim of Categorical
Exclusion or an Environmental
Assessment for Submission to the
Center for Food Safety and Applied
Nutrition’’ (the guidance). This
guidance provides information to
industry on how to prepare a claim of
categorical exclusion or an
environmental assessment (EA) for
submission to the Center for Food Safety
and Applied Nutrition (CFSAN) in
notifications for food contact
substances, food additive petitions,
color additive petitions, requests for
exemption from regulation as a food
additive, generally recognized as safe
(GRAS) petitions, and petitions for
certain food labeling regulations.
This guidance document is final
upon the date of publication. Submit
written or electronic comments
concerning this guidance document at
any time.
DATES:
E:\FR\FM\18MYN1.SGM
18MYN1
Federal Register / Vol. 71, No. 96 / Thursday, May 18, 2006 / Notices
Submit written requests for
single copies of the guidance document
to the Office of Food Additive Safety
(HFS–265), Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Include
a self-addressed adhesive label to assist
that office in processing your request.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. To
ensure a timelier processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Layla I. Batarseh, Center for Food Safety
and Applied Nutrition (HFS–246), 5100
Paint Branch Pkwy., College Park, MD,
20740–3835, 301–436–1296, FAX 301–
436–2973, or e-mail:
layla.batarseh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
wwhite on PROD1PC61 with NOTICES
ADDRESSES:
I. Background
As an integral part of its decisionmaking process, FDA is obligated under
the National Environmental Policy Act
of 1969 (NEPA) to consider the
environmental impact of its actions,
including allowing notifications for food
contact substances to become effective
and approving food additive petitions,
color additive petitions, GRAS
affirmation petitions, requests for
exemption from regulation as a food
additive, and actions on certain food
labeling citizen petitions, nutrient
content claims petitions, and health
claims petitions. In 1997, FDA amended
its regulations in 21 CFR part 25 to
provide for categorical exclusions for
additional classes of actions that do not
individually or cumulatively have a
significant effect on the human
environment (62 FR 40570, July 29,
1997). As a result of that rulemaking,
FDA no longer routinely requires
submission of information about the
manufacturing and production of FDAregulated articles. FDA also has
eliminated the previously required EA
and abbreviated EA formats from the
amended regulations. Instead, FDA is
providing this guidance that contains
sample formats to help industry submit
a claim of categorical exclusion or an
EA to CFSAN. This guidance document
identifies, interprets, and clarifies
existing requirements imposed by
statute and regulation, consistent with
VerDate Aug<31>2005
17:06 May 17, 2006
Jkt 208001
the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists
of recommendations that do not
themselves create requirements; rather,
they are explanatory guidance for FDA’s
own procedures in order to ensure full
compliance with the purposes and
provisions of NEPA.
This guidance provides information to
assist in the preparation of claims of
categorical exclusion and EAs for
submission to CFSAN. The following
topics are covered in this guidance: (1)
What types of industry-initiated actions
are subject to a claim of categorical
exclusion, (2) What must a claim of
categorical exclusion include by
regulation, (3) What is an EA, (4) When
is an EA required by regulation and
what format should be used, (5) What
are extraordinary circumstances, and (6)
What suggestions does CFSAN have for
preparing an EA? Although CFSAN
encourages industry to use the EA
formats described in this guidance
because standardized documentation
submitted by industry increases the
efficiency of the review process,
alternative approaches may be used if
these approaches satisfy the
requirements of the applicable statutes
and regulations.
In the Federal Register of September
17, 2003 (68 FR 54462), FDA announced
the availability of a draft guidance
document entitled ‘‘Guidance for
Industry: Preparing a Claim of
Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition.’’ The
agency solicited public comments on
the draft guidance document. FDA did
not receive any comments and is
finalizing the draft guidance without
revision, except for those revisions
necessary to update certain contact
information.
FDA is issuing this guidance
document as a level 1 guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance document represents
FDA’s current thinking on the
preparation of a claim of categorical
exclusion or an EA for submission to
CFSAN. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. You
may use an alternative approach if such
approach satisfies the requirements of
the applicable statutes and regulations.
If you want to discuss an alternative
approach, contact the FDA staff
responsible for implementing this
guidance (see FOR FURTHER INFORMATION
CONTACT).
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
28873
II. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
this guidance was approved under OMB
control number 0910–0541.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this guidance at
any time. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. The guidance document and
received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
https://www.cfsan.fda.gov/
guidance.html.
Dated: May 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7528 Filed 5–17–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG-2006-24700]
Chemical Transportation Advisory
Committee; Vacancies
Coast Guard, DHS.
Request for applications.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is seeking
applications for appointment to
membership on the Chemical
Transportation Advisory Committee
(CTAC). CTAC provides advice and
makes recommendations to the Coast
Guard on matters relating to the safe and
secure transportation and handling of
hazardous materials in bulk on U.S.-flag
vessels in U.S. ports and waterways.
DATES: Application forms should reach
the Coast Guard on or before September
29, 2006.
ADDRESSES: You may request an
application form by writing to
E:\FR\FM\18MYN1.SGM
18MYN1
]]>Agencies
[Federal Register Volume 71, Number 96 (Thursday, May 18, 2006)]
[Notices]
[Pages 28872-28873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0379] (formerly Docket No. 03D-0379)
Guidance for Industry: Preparing a Claim of Categorical Exclusion
or an Environmental Assessment for Submission to the Center for Food
Safety and Applied Nutrition; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Guidance for Industry:
Preparing a Claim of Categorical Exclusion or an Environmental
Assessment for Submission to the Center for Food Safety and Applied
Nutrition'' (the guidance). This guidance provides information to
industry on how to prepare a claim of categorical exclusion or an
environmental assessment (EA) for submission to the Center for Food
Safety and Applied Nutrition (CFSAN) in notifications for food contact
substances, food additive petitions, color additive petitions, requests
for exemption from regulation as a food additive, generally recognized
as safe (GRAS) petitions, and petitions for certain food labeling
regulations.
DATES: This guidance document is final upon the date of publication.
Submit written or electronic comments concerning this guidance document
at any time.
[[Page 28873]]
ADDRESSES: Submit written requests for single copies of the guidance
document to the Office of Food Additive Safety (HFS-265), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. Include a self-addressed
adhesive label to assist that office in processing your request. Submit
written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/
dockets/ecomments. To ensure a timelier processing of comments, FDA is
no longer accepting comments submitted to the agency by e-mail. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: Layla I. Batarseh, Center for Food
Safety and Applied Nutrition (HFS-246), 5100 Paint Branch Pkwy.,
College Park, MD, 20740-3835, 301-436-1296, FAX 301-436-2973, or e-
mail: layla.batarseh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
As an integral part of its decision-making process, FDA is
obligated under the National Environmental Policy Act of 1969 (NEPA) to
consider the environmental impact of its actions, including allowing
notifications for food contact substances to become effective and
approving food additive petitions, color additive petitions, GRAS
affirmation petitions, requests for exemption from regulation as a food
additive, and actions on certain food labeling citizen petitions,
nutrient content claims petitions, and health claims petitions. In
1997, FDA amended its regulations in 21 CFR part 25 to provide for
categorical exclusions for additional classes of actions that do not
individually or cumulatively have a significant effect on the human
environment (62 FR 40570, July 29, 1997). As a result of that
rulemaking, FDA no longer routinely requires submission of information
about the manufacturing and production of FDA-regulated articles. FDA
also has eliminated the previously required EA and abbreviated EA
formats from the amended regulations. Instead, FDA is providing this
guidance that contains sample formats to help industry submit a claim
of categorical exclusion or an EA to CFSAN. This guidance document
identifies, interprets, and clarifies existing requirements imposed by
statute and regulation, consistent with the Council on Environmental
Quality regulations (40 CFR 1507.3). It consists of recommendations
that do not themselves create requirements; rather, they are
explanatory guidance for FDA's own procedures in order to ensure full
compliance with the purposes and provisions of NEPA.
This guidance provides information to assist in the preparation of
claims of categorical exclusion and EAs for submission to CFSAN. The
following topics are covered in this guidance: (1) What types of
industry-initiated actions are subject to a claim of categorical
exclusion, (2) What must a claim of categorical exclusion include by
regulation, (3) What is an EA, (4) When is an EA required by regulation
and what format should be used, (5) What are extraordinary
circumstances, and (6) What suggestions does CFSAN have for preparing
an EA? Although CFSAN encourages industry to use the EA formats
described in this guidance because standardized documentation submitted
by industry increases the efficiency of the review process, alternative
approaches may be used if these approaches satisfy the requirements of
the applicable statutes and regulations.
In the Federal Register of September 17, 2003 (68 FR 54462), FDA
announced the availability of a draft guidance document entitled
``Guidance for Industry: Preparing a Claim of Categorical Exclusion or
an Environmental Assessment for Submission to the Center for Food
Safety and Applied Nutrition.'' The agency solicited public comments on
the draft guidance document. FDA did not receive any comments and is
finalizing the draft guidance without revision, except for those
revisions necessary to update certain contact information.
FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). This guidance document represents FDA's current thinking on
the preparation of a claim of categorical exclusion or an EA for
submission to CFSAN. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. You may use
an alternative approach if such approach satisfies the requirements of
the applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for
implementing this guidance (see FOR FURTHER INFORMATION CONTACT).
II. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0541.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this guidance
at any time. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. The guidance document and
received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance
document at https://www.cfsan.fda.gov/guidance.html.
Dated: May 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7528 Filed 5-17-06; 8:45 am]
BILLING CODE 4160-01-S
