Guidance for Industry on How To Write a Request for Designation; Availability, 21752-21753 [2011-9261]
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21752
Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices
ESTIMATED STATE MEDIAN INCOME FOR A FOUR-PERSON FAMILY, BY STATE, FOR FEDERAL FISCAL YEAR (FFY) 2012,
FOR USE IN THE LOW INCOME HOME ENERGY ASSISTANCE PROGRAM (LIHEAP)—Continued
Estimated State
median income for
four-person
families1
States
60 percent of estimated State median income for
four-person
families 2 3
78,287
87,669
64,228
68,064
63,480
65,508
70,322
74,877
85,546
81,788
58,739
77,946
75,998
46,972
52,601
38,537
40,838
38,088
39,305
42,193
44,926
51,328
49,073
35,243
46,768
45,599
Pennsylvania ................................................................................................................................................
Rhode Island ................................................................................................................................................
South Carolina .............................................................................................................................................
South Dakota ...............................................................................................................................................
Tennessee ...................................................................................................................................................
Texas ...........................................................................................................................................................
Utah .............................................................................................................................................................
Vermont .......................................................................................................................................................
Virginia .........................................................................................................................................................
Washington ..................................................................................................................................................
West Virginia ................................................................................................................................................
Wisconsin .....................................................................................................................................................
Wyoming ......................................................................................................................................................
Note: FFY 2012 covers the period of October 1, 2011, through September 30, 2012. The estimated median income for four-person families living in the United States for this period is $74,985. These estimates become effective for LIHEAP at any time between the date of this publication
and October 1, 2011, or the beginning of a LIHEAP grantee’s fiscal year, whichever is later.
1 Prepared by the U.S. Census Bureau, U.S. Department of Commerce (Census Bureau), from three-year estimates from the 2007, 2008 and
2009 American Community Surveys (ACSs). These estimates, like those derived from any survey, are subject to two types of errors: (1) Nonsampling Error, which consists of random errors that increase the variability of the data and non-random errors that consistently direct the data
into a specific direction; and (2) Sampling Error, which consists of the error that arises from the use of probability sampling to create the sample.
2 These figures were calculated by the U.S. Department of Health and Human Services, Administration for Children and Families, Office of
Community Services, Division of Energy Assistance (DEA) by multiplying the estimated State median income for a four-person family for each
State by 60 percent.
3 To adjust for different sizes of family, 45 CFR 96.85 calls for multiplying 60 percent of a State’s estimated median income for a four-person
family by the following percentages: 52 percent for one person, 68 percent for two persons, 84 percent for three persons, 100 percent for four
persons, 116 percent for five persons, and 132 percent for six persons. For each additional family member above six persons, 45 CFR 96.85
calls for adding 3 percentage points to the percentage for a six-person family (132 percent) and multiply the new percentage by 60 percent of a
State’s estimated median income for a four-person family.
[FR Doc. 2011–8993 Filed 4–15–11; 8:45 am]
BILLING CODE 4184–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0214]
Guidance for Industry on How To Write
a Request for Designation; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘How to Write a Request for
Designation (RFD).’’ This guidance is
intended to clarify the type of
information the Office of Combination
Products (OCP) recommends that a
sponsor include in a Request for
Designation (RFD). This final guidance
supersedes the previous RFD guidance
document issued August 2005.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:25 Apr 15, 2011
Jkt 223001
Office of Combination Products, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5129,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kristina Lauritsen, Office of
Combination Products, Food and Drug
Administration, Bldg. 32, rm. 5132,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–8936.
SUPPLEMENTARY INFORMATION:
needs to determine the regulatory
identity or classification of a product as
a drug, device, biological product, or
combination product, and to assign the
product to the appropriate Agency
component for review and regulation.
This final guidance supersedes the
previously issued RFD guidance
document which was published on
FDA’s Web site on August 2005.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on how to write an
RFD. 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 statutes
and regulations.
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘How to
Write a Request for Designation (RFD).’’
This guidance addresses 21 CFR 3.7 and
is intended to clarify the type of
information OCP recommends that a
sponsor include in an RFD. The goal of
this guidance is to help a sponsor
understand what information FDA
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information 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 collections of information in
21 CFR part 3 have been approved
under OMB control number 0910–0523.
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II. Paperwork Reduction Act of 1995
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Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. 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 document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm122047.htm or https://
www.regulations.gov.
I. Background
Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9261 Filed 4–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0240]
Site Tours Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Center for
Tobacco Products (CTP) is announcing
a notice for participation in its Site
Tours Program. This program is
intended to give CTP staff an
opportunity to visit facilities involved
in the growing, processing, or
manufacturing of tobacco or tobacco
products. These visits are intended to
provide CTP staff with the opportunity
to gain a better understanding of the
tobacco industry and its operations. The
purpose of this notice is to alert parties
interested in participating in the Site
Tours Program to submit requests to
CTP.
SUMMARY:
Interested parties should submit
either an electronic or written request
for participation by June 17, 2011. The
request should include a description of
your facility, including as applicable, a
list of all tobacco products processed
and/or manufactured there. Please
specify the physical address(es) of the
site(s) for which you are submitting a
erowe on DSK5CLS3C1PROD with NOTICES
DATES:
VerDate Mar<15>2010
15:25 Apr 15, 2011
Jkt 223001
request along with a proposed 1-day
tour agenda.
ADDRESSES: If your facility is interested
in offering a site visit, you should
submit a request to participate in the
program either electronically to https://
www.regulations.gov or in writing to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Lucinda Miner, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 877–287–1373,
e-mail: lucinda.miner@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Pub. L. 111–31; 123 Stat.
1776) was signed into law, amending
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) and giving FDA
authority to regulate tobacco product
manufacturing, distribution, and
marketing. This includes, among other
things, the authority to issue regulations
related to health warnings, tobacco
product standards, good manufacturing
practices, as well as tobacco product
constituents, ingredients, and additives.
CTP is instituting the Site Tours
Program to provide its scientific and
regulatory staff the opportunity to gain
a better understanding of the tobacco
industry and its operations, including
tobacco product manufacturing and
aspects of tobacco growing, processing,
and storage that may affect the physical
and chemical properties of tobacco.
Although FDA generally does not
regulate tobacco farms and tobacco
warehouses, the Agency believes that
gaining a better understanding of the
operations performed at these facilities
may be helpful. The goals of the Site
Tours Program are to: (1) Provide CTP
firsthand exposure to industry’s
manufacturing processes; (2) learn about
control measures used by tobacco
product manufacturers to ensure
product consistency; (3) understand the
processing of different forms of tobacco
and the manufacturing processes used
for various types of tobacco products
and their influences on product
constituents; and (4) understand how
growing conditions, curing, storage, and
manufacturing processes might
influence the levels of tobacco or
tobacco smoke constituents.
II. Description of Site Tours Program
In the Site Tours Program, small
groups of CTP staff plan to observe the
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21753
operations of tobacco growers, tobacco
warehouses, and manufacturing
facilities of cigarette, roll-your-own, and
smokeless tobacco companies. Please
note that the Site Tours Program is not
intended to include official FDA
inspections of facilities to determine
compliance with the FD&C Act; rather,
the program is meant to educate CTP
staff and improve their understanding of
the tobacco industry and its operations.
III. Site Selection
CTP plans to select one or more of
each of the following types of facilities:
A large cigarette manufacturing facility,
a small cigarette manufacturing facility,
a smokeless tobacco manufacturing
facility, a burley tobacco farm, a fluecured tobacco farm, a tobacco rolling
paper facility, and a tobacco warehouse.
All travel expenses associated with the
site tours will be the responsibility of
CTP. Final site selections will be based
on the availability of CTP funds and
resources for the relevant fiscal year, as
well as the following factors:
(1) Compliance status of the requesting
facility and affiliated firm, if applicable;
(2) whether the requesting facility is in
arrears for user fees; (3) whether the
requesting facility or affiliated firm, if
applicable, has a significant request or
marketing application or submission
pending with FDA; and (4) whether the
requesting facility will be engaged in
active manufacturing or processing
during the proposed time of the visit.
IV. Requests for Participation
Requests are to be identified with the
docket number found in brackets in the
heading of this document. Requests
received by the Agency are available for
public examination in the Division of
Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9260 Filed 4–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Noncompetitive Program Extension
Supplemental Awards
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
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Notice.
18APN1
]]>Agencies
[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21752-21753]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9261]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0214]
Guidance for Industry on How To Write a Request for Designation;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``How to Write a
Request for Designation (RFD).'' This guidance is intended to clarify
the type of information the Office of Combination Products (OCP)
recommends that a sponsor include in a Request for Designation (RFD).
This final guidance supersedes the previous RFD guidance document
issued August 2005.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Office of Combination Products, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kristina Lauritsen, Office of
Combination Products, Food and Drug Administration, Bldg. 32, rm. 5132,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8936.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``How to Write a Request for Designation (RFD).'' This
guidance addresses 21 CFR 3.7 and is intended to clarify the type of
information OCP recommends that a sponsor include in an RFD. The goal
of this guidance is to help a sponsor understand what information FDA
needs to determine the regulatory identity or classification of a
product as a drug, device, biological product, or combination product,
and to assign the product to the appropriate Agency component for
review and regulation. This final guidance supersedes the previously
issued RFD guidance document which was published on FDA's Web site on
August 2005.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on how to write an RFD. 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 statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information in 21 CFR part 3 have been approved under
OMB control number 0910-0523.
[[Page 21753]]
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. 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 document at
either https://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm
or https://www.regulations.gov.
Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9261 Filed 4-15-11; 8:45 am]
BILLING CODE 4160-01-P
