Submission for OMB Review; Comment Request, 7998-7999 [07-790]
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7998
Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices
Medicare Beneficiary Database (09–70–
0530), and other payer information to be
provided by the TROOP Facilitator.
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2)).
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE PRIVACY ACT:
None.
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORD SOURCE CATEGORIES:
Summary prescription drug claim
information contained in this system is
obtained from the Prescription Benefit
Package (PBP) Plans and Medicare
Advantage (MA–PBP) Plans daily and
monthly drug event transaction reports,
[FR Doc. E7–2984 Filed 2–21–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: National Directory of New
Hires.
OMB No.: 0970–0166.
Description: Public Law 104–193, the
‘‘Personal Responsibility and Work
Number of
respondents
Instrument
rwilkins on PROD1PC63 with NOTICES
New Hire: Employers Reporting Manually ...................................................
New Hire: Employers Reporting Electronically ............................................
New Hire: States ..........................................................................................
Quarterly Wage & Unemployment Compensation ......................................
Multistate Employers’ Notification Form ......................................................
Estimated Total Annual Burden
Hours: 760,828.
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. E-mail
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after the 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: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
VerDate Aug<31>2005
14:11 Feb 21, 2007
Jkt 211001
Number of
responses per
respondent
5,166,000
1,134,000
54
54
2,808
Dated: February 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–789 Filed 2–21–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Needs Assessment for
Promoting Cultural Competence and
Diversity in Youth Mentoring Programs
Toolkit.
OMB No.: New Collection.
Description: The Department of
Health and Human Services’ (HHS)
Mentoring Children of Prisoners (MCP)
program, administered under the Family
Youth Services Bureau (FYSB) within
the Administration for Children and
Families (ACF), was authorized by the
Promoting Safe and Stable Families Act
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Fmt 4703
Sfmt 4703
Opportunity Reconciliation Act of
1996,’’ requires the Office of Child
Support Enforcement (OCSE) to operate
a National Directory of New Hires
(NDNH) to improve the ability of State
child support enforcement agencies to
locate noncustodial parents and collect
child support across State lines. The law
requires employers to report newly
hired employees to States. States are
then required to periodically transmit
new hire data received from employers
to the NDNH, and to transmit wage and
unemployment compensation claims
data to the NDNH on a quarterly basis.
Federal agencies are required to report
new hires and quarterly wage data
directly to the NDNH. All data is
transmitted to the NDNH electronically.
Respondents: Employers, State Child
Support Enforcement Agencies, State
Workforce Agencies, Federal Agencies.
Annual Burden Estimates:
Average burden
hours per
response
3.484
33.272
83.333
8
1
.025
.00028
66.7
.033
.050
Total burden
hours
449,959
10,565
300,150
14
140
of 2001 (SSFA, Pub. L. 107–133). The
MCP program is designed to nurture
children who have one or both parents
incarcerated. The Secretary of HHS is
mandated to appropriate funds for the
MCP grant program, specifically for
evaluation, research, training, and
technical assistance. In FY 2004,
grantees began submitting progress
reports to HHS.
FYSB will conduct an assessment of
the mentoring community to identify
and assess needs for the purpose of
building a toolkit of practical
information and tools to assist
mentoring programs in promoting
cultural competence and diversity of
their programs. The toolkit modules
address recruiting minority mentors,
assessing and matching mentors and
mentees, training, educating program
staff and participants, and promoting
ethnic identity development.
Respondents: Mentoring Children of
Prisoners grantees and National
Mentoring Partnership (MENTOR)
affiliated mentoring organizations.
Annual Burden Estimates:
E:\FR\FM\22FEN1.SGM
22FEN1
7999
Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices
Number of
respondents
Instrument
Mentoring ToolKit Web-based Needs Assessment Questionannaire ...........
Mentoring ToolKit Web-based focus group ...................................................
Mentoring ToolKit Web-based Feedback questionnaire ...............................
Estimated Total Annual Burden
Hours: 397
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
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: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: February 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–790 Filed 2–21–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0252]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LEVEMIR
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LEVEMIR 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
VerDate Aug<31>2005
17:50 Feb 21, 2007
Jkt 211001
Number of
responses per
respondent
Average burden
hours per
response
1
1
1
.75
1
.25
442
40
100
Commerce, for the extension of a patent
that claims that human drug product.
ADDRESSES: Submit written 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
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 drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
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 drug product and continues
until FDA grants permission to market
the 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 drug 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 drug product LEVEMIR
(insulin determir (rDNA origin)).
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Fmt 4703
Sfmt 4703
Total burden
hours
332
40
25
LEVEMIR is indicated for once or twicedaily subcutaneous administration in
the treatment of adult patients with
diabetes mellitus who require basal
(long acting) insulin for the control of
hyperglycemia. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for LEVEMIR (U.S. Patent
No. 5,750,497) from Novo Nordisk A/S,
and the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 24, 2006, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of LEVEMIR 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.
FDA has determined that the
applicable regulatory review period for
LEVEMIR is 2,896 days. Of this time,
1,971 days occurred during the testing
phase of the regulatory review period,
while 925 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 (the act) (21 U.S.C.
355) became effective: July 14, 1997.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 14, 1997.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 5, 2002.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
LEVIMIR (NDA 21–536) was initially
submitted on December 5, 2002.
3. The date the application was
approved: June 16, 2005. FDA has
verified the applicant’s claim that NDA
21–536 was approved on June 16, 2005.
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,
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 72, Number 35 (Thursday, February 22, 2007)]
[Notices]
[Pages 7998-7999]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Needs Assessment for Promoting Cultural Competence and
Diversity in Youth Mentoring Programs Toolkit.
OMB No.: New Collection.
Description: The Department of Health and Human Services' (HHS)
Mentoring Children of Prisoners (MCP) program, administered under the
Family Youth Services Bureau (FYSB) within the Administration for
Children and Families (ACF), was authorized by the Promoting Safe and
Stable Families Act of 2001 (SSFA, Pub. L. 107-133). The MCP program is
designed to nurture children who have one or both parents incarcerated.
The Secretary of HHS is mandated to appropriate funds for the MCP grant
program, specifically for evaluation, research, training, and technical
assistance. In FY 2004, grantees began submitting progress reports to
HHS.
FYSB will conduct an assessment of the mentoring community to
identify and assess needs for the purpose of building a toolkit of
practical information and tools to assist mentoring programs in
promoting cultural competence and diversity of their programs. The
toolkit modules address recruiting minority mentors, assessing and
matching mentors and mentees, training, educating program staff and
participants, and promoting ethnic identity development.
Respondents: Mentoring Children of Prisoners grantees and National
Mentoring Partnership (MENTOR) affiliated mentoring organizations.
Annual Burden Estimates:
[[Page 7999]]
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Mentoring ToolKit Web-based Needs Assessment 442 1 .75 332
Questionannaire................................
Mentoring ToolKit Web-based focus group......... 40 1 1 40
Mentoring ToolKit Web-based Feedback 100 1 .25 25
questionnaire..................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 397
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
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-
6974, Attn: Desk Officer for the Administration for Children and
Families.
Dated: February 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07-790 Filed 2-21-07; 8:45 am]
BILLING CODE 4184-01-M
