Delegation of Authority, 24294-24295 [E8-9634]
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Federal Register / Vol. 73, No. 86 / Friday, May 2, 2008 / Notices
the education and training needs of its
partner organizations on an annual
basis, to ensure that they have the
information and materials they need to
assist the beneficiaries they serve. Form
Number: CMS–10257 (OMB# 0938New); Frequency: Once; Affected Public:
Not-for-profit institutions, State, Local
and Tribal governments, Federal
Government; Number of Respondents:
4,000; Total Annual Responses: 4,000;
Total Annual Hours: 1,000.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by July 1, 2008:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier/OMB Control
Number lll, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 24, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–9503 Filed 5–1–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on PROD1PC66 with NOTICES
Administration for Children and
Families
Delegation of Authority
Notice is hereby given that I have
delegated to the Associate
Commissioner, Children’s Bureau,
Administration for Children, Youth and
VerDate Aug<31>2005
17:17 May 01, 2008
Jkt 214001
Families, the following authorities
vested in me by the Assistant Secretary
for Children and Families by
memorandum dated February 16, 2007.
(a) Authorities Delegated.
1. Authority to administer the Child
Welfare Services Program, including the
State Grant Program, the Research and
Demonstration Program and the
Training program pursuant to Title IV–
B of the Social Security Act, and as
amended now and hereafter.
2. Authority to administer the Foster
Care Program and Adoption Assistance
programs including the Independent
Living Initiative under Title IV–E of the
Social Security Act, and as amended
now and hereafter.
3. Authority to administer the
provisions of the Child Abuse
Prevention and Treatment Act, 42
U.S.C. 5101 et seq., and as amended
now and hereafter.
4. Authority to administer the
provisions of the Adoption
Opportunities Program under Title II of
the Child Abuse Prevention and
Treatment and Adoption Reform Act, 42
U.S.C. 5111–5115, and as amended now
and hereafter.
5. Authorities and functions vested in
the Secretary under the Organic Act of
the Children’s Bureau (Act of April 9,
1912) 42 U.S.C. 191, et seq., and as
amended now and hereafter.
6. Authorities that provide for the
establishment of A National Adoption
Information Clearinghouse under
Section 9442 of the Omnibus Budget
Reconciliation Act of 1986, 42 U.S.C.
679a, and as amended now and
hereafter.
7. Authorities to administer the
Abandoned Infants Assistance Act of
1988, 42 U.S.C. 670 note, and as
amended now and hereafter.
8. Authority under Section
13711(a)(2) of the Omnibus Budget
Reconciliation Act of 1993, Pub. L. 103–
66, for the Family Preservation and
Support Services program, subpart 2 of
the Title IV–B, Child and Family
Services, of the Social Security Act 42
U.S.C. 629, and as amended now and
hereafter.
9. Authorities vested in the Secretary
of Health and Human Services under
Section 330F (other than Section
330F(a)(6)(C)) of the Public Health
Service Act (42 U.S.C. 254c–6), as
amended, titled ‘‘Certain Services for
Pregnant Women.’’
(b) Limitations.
1. This delegation of authority shall
be exercised under the Department’s
existing policies on delegations and
regulations.
2. This delegation excludes the
authority to submit reports to Congress
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and shall be exercised under financial
and administrative requirements
applicable to all Administration for
Children and Families’ authorities.
3. The approval or disapproval of
grant applications and the making of
grant awards require concurrence of the
appropriate Grants Officer. The
approval or disapproval of contract
proposals and awards are subject to the
requirements of the Federal Acquisition
Regulations and requires the
concurrence of the Contracting Officer.
4. This delegation of authority does
not include the authority to sign and
issue notices of grant awards for
Children’s Bureau programs.
5. This delegation of authority does
not include the authority to appoint
Central Office and Regional Office Grant
Officers for the administration of
Children’s Bureau programs.
6. This delegation of authority does
not include the authority to appoint
Action Officials for Audit Resolution.
7. This delegation of authority does
not include the authority to approve or
disapprove State requests for Federal
financial participation for the costs of
automated data processing equipment
and services that affect more than one
HHS Operating Division.
8. This delegation of authority does
not include the authority to conduct
hearings.
9. This delegation of authority does
not include the authority under section
429 of the Social Security Act.
10. This delegation of authority does
not include the authority under section
439 of the Social Security Act, Grants
for Programs for Mentoring Children of
Prisoners.
11. Any redelegation shall be in
writing and prompt notification must be
provided to all affected managers,
supervisors, and other personnel and
requires the concurrence of the Deputy
Assistant Secretary for Administration.
(c) Effective Date.
This delegation of authority is
effective upon the date of signature.
(d) Effect on Existing Delegations.
As related to the authorities delegated
herein, this delegation of authority
supersedes all previous delegations of
authority.
I hereby affirm and ratify any actions
taken by the Associate Commissioner,
Children’s Bureau, Administration on
Children, Youth and Families, which
involved the exercise of the authorities
delegated herein prior to the effective
date of this delegation.
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02MYN1
Federal Register / Vol. 73, No. 86 / Friday, May 2, 2008 / Notices
Dated: April 18, 2008,
Joan Ohl,
Commissioner, Administration for Children,
Youth and Families.
[FR Doc. E8–9634 Filed 5–1–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–E–0282] (formerly
Docket No. 2007E–0256)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TEKTURNA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TEKTURNA 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 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.regulations.gov.
mstockstill on PROD1PC66 with NOTICES
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
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
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17:17 May 01, 2008
Jkt 214001
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 drug 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 TEKTURNA
(aliskiren hemifumarate). TEKTURNA is
indicated for treatment of hypertension.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
TEKTURNA (U.S. Patent No. 5,559,111)
from Novartis Corporation, and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated November
21, 2007, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
TEKTURNA represented the first
permitted commercial marketing or use
of the product. Shortly, 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
TEKTURNA is 2,023 days. Of this time,
1,637 days occurred during the testing
phase of the regulatory review period,
while 386 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(i)) became effective: August 22,
2001. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on August 22, 2001.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: February 13, 2006.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
TEKTURNA (NDA 21–985) was initially
submitted on February 13, 2006.
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24295
3. The date the application was
approved: March 5, 2007. FDA has
verified the applicant’s claim that NDA
21–985 was approved on March 5, 2007.
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 2,022 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 July 1, 2008.
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
October 29, 2008. 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
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: April 21, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–9699 Filed 5–1–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Cardiac Contractility,
Hypertrophy, and Failure Study
E:\FR\FM\02MYN1.SGM
02MYN1
]]>Agencies
[Federal Register Volume 73, Number 86 (Friday, May 2, 2008)]
[Notices]
[Pages 24294-24295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9634]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Delegation of Authority
Notice is hereby given that I have delegated to the Associate
Commissioner, Children's Bureau, Administration for Children, Youth and
Families, the following authorities vested in me by the Assistant
Secretary for Children and Families by memorandum dated February 16,
2007.
(a) Authorities Delegated.
1. Authority to administer the Child Welfare Services Program,
including the State Grant Program, the Research and Demonstration
Program and the Training program pursuant to Title IV-B of the Social
Security Act, and as amended now and hereafter.
2. Authority to administer the Foster Care Program and Adoption
Assistance programs including the Independent Living Initiative under
Title IV-E of the Social Security Act, and as amended now and
hereafter.
3. Authority to administer the provisions of the Child Abuse
Prevention and Treatment Act, 42 U.S.C. 5101 et seq., and as amended
now and hereafter.
4. Authority to administer the provisions of the Adoption
Opportunities Program under Title II of the Child Abuse Prevention and
Treatment and Adoption Reform Act, 42 U.S.C. 5111-5115, and as amended
now and hereafter.
5. Authorities and functions vested in the Secretary under the
Organic Act of the Children's Bureau (Act of April 9, 1912) 42 U.S.C.
191, et seq., and as amended now and hereafter.
6. Authorities that provide for the establishment of A National
Adoption Information Clearinghouse under Section 9442 of the Omnibus
Budget Reconciliation Act of 1986, 42 U.S.C. 679a, and as amended now
and hereafter.
7. Authorities to administer the Abandoned Infants Assistance Act
of 1988, 42 U.S.C. 670 note, and as amended now and hereafter.
8. Authority under Section 13711(a)(2) of the Omnibus Budget
Reconciliation Act of 1993, Pub. L. 103-66, for the Family Preservation
and Support Services program, subpart 2 of the Title IV-B, Child and
Family Services, of the Social Security Act 42 U.S.C. 629, and as
amended now and hereafter.
9. Authorities vested in the Secretary of Health and Human Services
under Section 330F (other than Section 330F(a)(6)(C)) of the Public
Health Service Act (42 U.S.C. 254c-6), as amended, titled ``Certain
Services for Pregnant Women.''
(b) Limitations.
1. This delegation of authority shall be exercised under the
Department's existing policies on delegations and regulations.
2. This delegation excludes the authority to submit reports to
Congress and shall be exercised under financial and administrative
requirements applicable to all Administration for Children and
Families' authorities.
3. The approval or disapproval of grant applications and the making
of grant awards require concurrence of the appropriate Grants Officer.
The approval or disapproval of contract proposals and awards are
subject to the requirements of the Federal Acquisition Regulations and
requires the concurrence of the Contracting Officer.
4. This delegation of authority does not include the authority to
sign and issue notices of grant awards for Children's Bureau programs.
5. This delegation of authority does not include the authority to
appoint Central Office and Regional Office Grant Officers for the
administration of Children's Bureau programs.
6. This delegation of authority does not include the authority to
appoint Action Officials for Audit Resolution.
7. This delegation of authority does not include the authority to
approve or disapprove State requests for Federal financial
participation for the costs of automated data processing equipment and
services that affect more than one HHS Operating Division.
8. This delegation of authority does not include the authority to
conduct hearings.
9. This delegation of authority does not include the authority
under section 429 of the Social Security Act.
10. This delegation of authority does not include the authority
under section 439 of the Social Security Act, Grants for Programs for
Mentoring Children of Prisoners.
11. Any redelegation shall be in writing and prompt notification
must be provided to all affected managers, supervisors, and other
personnel and requires the concurrence of the Deputy Assistant
Secretary for Administration.
(c) Effective Date.
This delegation of authority is effective upon the date of
signature.
(d) Effect on Existing Delegations.
As related to the authorities delegated herein, this delegation of
authority supersedes all previous delegations of authority.
I hereby affirm and ratify any actions taken by the Associate
Commissioner, Children's Bureau, Administration on Children, Youth and
Families, which involved the exercise of the authorities delegated
herein prior to the effective date of this delegation.
[[Page 24295]]
Dated: April 18, 2008,
Joan Ohl,
Commissioner, Administration for Children, Youth and Families.
[FR Doc. E8-9634 Filed 5-1-08; 8:45 am]
BILLING CODE 4184-01-P
