Submission for OMB Review; Comment Request, 40204-40205 [E9-19170]
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40204
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
PHASE VI ESTIMATE OF RESPONDENT BURDEN—Continued
[Note: Total burden is annualized over a 5-year period]
Respondent
Number of
respondents
13,274 ................................
Total Summary ............
Total average
number of
responses per
respondent
........................
Instrument
271,439
Hours per
response
........................
Total burden
hours
5-Year average annual
burden hours
28,156
1 An
average of 23 stakeholders in up to 26 grant communities will complete the System of Care Assessment interview. These stakeholders
will include site administrative staff, providers, agency representatives, family representatives, and youth.
2 Number of respondents across 26 grantees (5223), in addition to 318 children/families from the comparison sample. Average based on a 5
percent attrition rate at each data collection point.
3 Number of responses per respondent is five over the course of the study (once every 6 months for 24 months, with one baseline/intake response, and 4 follow-up responses).
4 Approximate number of caregivers with children over age 5, based on Phase IV data submitted as of 12/08. Also includes 318 children/families from the comparison sample.
5 Approximate number of caregivers with children 3 and older, based on Phase IV data submitted as of 12/08. Also includes 318 children/families from the comparison sample.
6 Approximate number of caregivers with either: (1) Children served at the roughly 7 early childhood-focused communities, for whom the instrument is required; or (2) children aged 0 to 12 at other communities, where the instrument is optional (we estimate that 1⁄3 of caregivers will be
administered the instrument when it is optional). Estimates are based on Phase IV data submitted as of 12/08.
7 Approximate number of caregivers with either: (1) Children served at the roughly 7 early childhood-focused communities, for whom the instrument is required; or (2) children aged 0 to 5 at other communities, where the instrument is optional (we estimate that 1⁄3 of caregivers will be administered the instrument when it is optional). Estimates are based on Phase IV data submitted as of 12/08.
8 Based on Phase IV finding that approximately 63 percent of the children in the evaluation were 11 years old or older. Also includes 318 children/families from the comparison sample.
9 With the exception of the MSSC–R, respondents only complete Service Experience Study measures at follow-up points. See Footnote #3 for
the explanation about the average number of responses per respondent.
10 Approximate number of children/families in each sector, for the Sector and Comparison Study. This includes cases within the communities,
as well as within the comparison sample.
11 For each community, 1 respondent will be a caregiver and 3 respondents will be administrators/providers.
12 Assumes that each community will use flexible funds expenditures on average for approximately one quarter of the children/youth enrolled.
13 Assumes that three expenditures, on average, will be spent on each child/youth receiving flexible fund benefits.
14 Assumes that each child/youth in system of care communities and in the comparison sample will have 100 service episodes, on average.
15 Total Annual Burden (hours) is the product of Number of Distinct Respondents × Average Annual Number of Responses per Respondent ×
Average 5-Year Burden per Response (hours).
Written comments and
recommendations concerning the
proposed information collection should
be sent by September 10, 2009 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
5806.
Dated: August 5, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–19228 Filed 8–10–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ACF Uniform Project
Description.
OMB No.: 0970–0139.
Description: The Administration for
Children and Families (ACF) has more
than 50 discretionary grant programs.
The proposed information collection
form would be a uniform discretionary
application form eligible for use by
grant applicants to submit project
information in response to ACF program
announcements. ACF would use this
information, along with other OMB-
approved information collections, to
evaluate and rank applicants and
protect the integrity of the grantee
selection process. All ACF discretionary
grant programs would be eligible but not
required to use this application form.
The application consists of general
information and instructions; the
Standard Form 424 series that requests
basic information, budget information
and assurances; the Project Description
requesting the applicant to describe how
these objectives will be achieved; along
with assurances and certifications.
Guidance for the content of information
requested in the Project Description is
found in OMB Circular A–102 and 45
CFR Part 74.
Respondents: Applicants for ACF
Discretionary Grant Programs.
ANNUAL BURDEN ESTIMATES
sroberts on DSKD5P82C1PROD with NOTICES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
UPD ...............................................................................................................
6,752
1
40
270,080
Estimated Total Annual Burden
Hours: 270,080
Additional Information: Copies of the
proposed collection may be obtained by
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
PO 00000
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Fmt 4703
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Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
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Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication 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, Fax: 202–395–7245,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: August 6, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–19170 Filed 8–10–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0053]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NPLATE
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NPLATE and is publishing this notice of
that determination as required by law.
FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human biological
product.
ADDRESSES: Submit written or electronic
comments and petitions 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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
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20:51 Aug 10, 2009
Jkt 217001
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (for example,
half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human biologic product NPLATE
(romiplostim). NPLATE is indicated for
the treatment of thrombocytopenia in
patients with chronic immune
(idiopathic) thrombocytopenic purpura
(ITP) who have had an insufficient
response to corticosteroids,
immunoglobulins, or splenectomy.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
NPLATE (U.S. Patent No. 6,835,809)
from Amgen Inc., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated February 26, 2009, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
NPLATE represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
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40205
FDA has determined that the
applicable regulatory review period for
NPLATE is 2,319 days. Of this time,
2,014 days occurred during the testing
phase of the regulatory review period,
while 305 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: April 19, 2002. The
applicant claims April 23, 2002, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was April 19, 2002,
the date of the FDA correspondence
removing the clinical hold on the
application.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): October 23, 2007. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
NPLATE (BLA 125268/0) was initially
submitted on October 23, 2007.
3. The date the application was
approved: August 22, 2008. FDA has
verified the applicant’s claim that BLA
125268/0 was approved on August 22,
2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 818 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by October 13, 2009.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 8, 2010. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
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]]>Agencies
[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40204-40205]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: ACF Uniform Project Description.
OMB No.: 0970-0139.
Description: The Administration for Children and Families (ACF) has
more than 50 discretionary grant programs. The proposed information
collection form would be a uniform discretionary application form
eligible for use by grant applicants to submit project information in
response to ACF program announcements. ACF would use this information,
along with other OMB-approved information collections, to evaluate and
rank applicants and protect the integrity of the grantee selection
process. All ACF discretionary grant programs would be eligible but not
required to use this application form. The application consists of
general information and instructions; the Standard Form 424 series that
requests basic information, budget information and assurances; the
Project Description requesting the applicant to describe how these
objectives will be achieved; along with assurances and certifications.
Guidance for the content of information requested in the Project
Description is found in OMB Circular A-102 and 45 CFR Part 74.
Respondents: Applicants for ACF Discretionary Grant Programs.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
UPD........................................ 6,752 1 40 270,080
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 270,080
Additional Information: Copies of the proposed collection may be
obtained by 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
[[Page 40205]]
information collection. E-mail address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication 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, Fax: 202-395-
7245, Attn: Desk Officer for the Administration for Children and
Families.
Dated: August 6, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9-19170 Filed 8-10-09; 8:45 am]
BILLING CODE 4184-01-P
