Proposed Data Collections Submitted for Public Comment and Recommendations, 29171-29172 [E7-10031]
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29171
Federal Register / Vol. 72, No. 100 / Thursday, May 24, 2007 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden response
(in hours)
Total burden
(in hours)
Reader Response Card ...................................................................................
8,000
1
10/60
1,333
Dated: May 18, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–10030 Filed 5–23–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–07–0658]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
process. Because this program
encompasses approximately 32 CBA
provider organizations, there is a
continued need for a standardized
system for reporting individual episodes
of CBA delivered by all CBA provider
grantees. The information collected
from the Trimester Progress Report,
CBA Notification, CBA Completion
Form, and the CBA Training Events
Report, will allow CDC to further
identify problems and technical
assistance needs of community-based
organization CBO, or CBA grantees in a
timely fashion and subsequently
improve the effectiveness of CBA
program activities and to ensure that
they are aligned with national goals.
The data collected using the CBA
Notification and Completion Forms, and
the Training Events Report are now
being collected via a Web portal
(https://www.cdc.gov/hiv/cba) that has
gone through a Certification and
Accreditation process. Continued
collection of this data in addition to the
Trimester Progress Report will assist
CDC, to aggregate data, and to discern
and refine national goals and objectives
for HIV prevention capacity building.
This information collection process is
also valuable for grantees as a
management tool to routinely examining
CBA program performance by assessing
strengths and weaknesses in line with
the CBA program, performance
indicators, and national objectives.
It is estimated that form A (will
require 4 hours of preparation by the
respondent, form B will require 15
minutes of preparation by the
respondent, and form C will require 30
minutes of preparation by the
respondent, and Form D will require 2
hours of preparation by the respondent.
In aggregate, report preparation requires
approximately 1952 burden hours by
each respondent. There is no cost to
respondents other than their time.
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Capacity Building Assistance (CBA)
Information, Collection, Reporting, and
Monitoring (OMB# 0920–0658)—three
year extension of the currently approved
collection—National Center for HIV and
AIDS, Viral Hepatitis, Sexually
Transmitted Disease, Tuberculosis
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of this request is to
obtain OMB clearance to extend the 3year clearance for information collection
to monitor the HIV prevention activities
of CBA provider grantees funded by
CDC to provide HIV prevention CBA
from April, 1 2004 through March 31,
2009. Capacity building is a key strategy
for the promotion and sustainability of
health prevention programs. Capacity
building generally refers to the skills,
infrastructure, and resources of
organizations and communities that are
necessary to effect and maintain
behavior change, thus reducing the level
of risk for disease, disability, and injury.
CDC is responsible for monitoring and
evaluating HIV prevention activities
conducted under these cooperative
agreement numbers 04019, 05015, and
06608. Reporting and monitoring forms
have been used to collect information
that assists in enhancing and assuring
quality programming. CDC requires
current information regarding CBA
activities and services supported
through these cooperative agreements.
Therefore, forms such as the Trimester
Interim Progress Report, CBA
Notification Form, CBA Completion
Form, and the CBA Training Events
Report are considered a critical
component of the monitoring/evaluation
rmajette on PROD1PC67 with NOTICES
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Form name
Number of
respondents
Form A: CBA Trimester Report ......................
Form B: CBA Notification Form ......................
Form C: CBA Completion Form .....................
32 Grantees ...................................................
32 CBA Provider Grantees ............................
32 CBA Provider Grantees ............................
VerDate Aug<31>2005
15:52 May 23, 2007
Jkt 211001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
E:\FR\FM\24MYN1.SGM
3
50
25
24MYN1
Average
burden hours
per response
4
15/60
30/60
Response
burden
(in hours)
384
400
400
29172
Federal Register / Vol. 72, No. 100 / Thursday, May 24, 2007 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Average
burden hours
per response
Response
burden
(in hours)
Form name
Number of
respondents
Form D: CBA Training Events Report ............
32 CBA Provider Grantees ............................
12
2
768
Total .........................................................
.........................................................................
........................
........................
1952
Dated: May 18, 2007.
Maryam Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–10031 Filed 5–23–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E–0457]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SOMAVERT
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SOMAVERT 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), 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
VerDate Aug<31>2005
15:52 May 23, 2007
Jkt 211001
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 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 SOMAVERT
(pegvisomant). SOMAVERT is indicated
for the treatment of acromegaly in
patients who have had an inadequate
response to surgery and/or radiation
therapy and/or other medical therapies,
or for whom these therapies are not
appropriate. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for SOMAVERT (U.S. Patent
No. 5,849,535) from Genentech, 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
April 6, 2004, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of SOMAVERT 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.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
FDA has determined that the
applicable regulatory review period for
SOMAVERT is 2,169 days. Of this time,
1,349 days occurred during the testing
phase of the regulatory review period,
while 820 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: April 18, 1997.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on April 18, 1997.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 26, 2000.
The applicant claims December 22,
2000, as the date the new drug
application (NDA) for SOMAVERT
(NDA 21–106) was initially submitted.
However, FDA records indicate that
NDA 21–106 was submitted on
December 26, 2000.
3. The date the application was
approved: March 25, 2003. FDA has
verified the applicant’s claim that NDA
21–106 was approved on March 25,
2003.
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 466 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 23, 2007.
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
November 20, 2007. 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.
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 72, Number 100 (Thursday, May 24, 2007)]
[Notices]
[Pages 29171-29172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-0658]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Maryam Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Capacity Building Assistance (CBA) Information, Collection,
Reporting, and Monitoring (OMB 0920-0658)--three year
extension of the currently approved collection--National Center for HIV
and AIDS, Viral Hepatitis, Sexually Transmitted Disease, Tuberculosis
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of this request is to obtain OMB clearance to extend
the 3-year clearance for information collection to monitor the HIV
prevention activities of CBA provider grantees funded by CDC to provide
HIV prevention CBA from April, 1 2004 through March 31, 2009. Capacity
building is a key strategy for the promotion and sustainability of
health prevention programs. Capacity building generally refers to the
skills, infrastructure, and resources of organizations and communities
that are necessary to effect and maintain behavior change, thus
reducing the level of risk for disease, disability, and injury. CDC is
responsible for monitoring and evaluating HIV prevention activities
conducted under these cooperative agreement numbers 04019, 05015, and
06608. Reporting and monitoring forms have been used to collect
information that assists in enhancing and assuring quality programming.
CDC requires current information regarding CBA activities and services
supported through these cooperative agreements. Therefore, forms such
as the Trimester Interim Progress Report, CBA Notification Form, CBA
Completion Form, and the CBA Training Events Report are considered a
critical component of the monitoring/evaluation process. Because this
program encompasses approximately 32 CBA provider organizations, there
is a continued need for a standardized system for reporting individual
episodes of CBA delivered by all CBA provider grantees. The information
collected from the Trimester Progress Report, CBA Notification, CBA
Completion Form, and the CBA Training Events Report, will allow CDC to
further identify problems and technical assistance needs of community-
based organization CBO, or CBA grantees in a timely fashion and
subsequently improve the effectiveness of CBA program activities and to
ensure that they are aligned with national goals. The data collected
using the CBA Notification and Completion Forms, and the Training
Events Report are now being collected via a Web portal (https://
www.cdc.gov/hiv/cba) that has gone through a Certification and
Accreditation process. Continued collection of this data in addition to
the Trimester Progress Report will assist CDC, to aggregate data, and
to discern and refine national goals and objectives for HIV prevention
capacity building. This information collection process is also valuable
for grantees as a management tool to routinely examining CBA program
performance by assessing strengths and weaknesses in line with the CBA
program, performance indicators, and national objectives.
It is estimated that form A (will require 4 hours of preparation by
the respondent, form B will require 15 minutes of preparation by the
respondent, and form C will require 30 minutes of preparation by the
respondent, and Form D will require 2 hours of preparation by the
respondent. In aggregate, report preparation requires approximately
1952 burden hours by each respondent. There is no cost to respondents
other than their time.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average Response
Form name Number of respondents responses per burden hours burden (in
respondent per response hours)
----------------------------------------------------------------------------------------------------------------
Form A: CBA Trimester Report.......... 32 Grantees............. 3 4 384
Form B: CBA Notification Form......... 32 CBA Provider Grantees 50 15/60 400
Form C: CBA Completion Form........... 32 CBA Provider Grantees 25 30/60 400
[[Page 29172]]
Form D: CBA Training Events Report.... 32 CBA Provider Grantees 12 2 768
-----------------------------------------------
Total............................. ........................ .............. .............. 1952
----------------------------------------------------------------------------------------------------------------
Dated: May 18, 2007.
Maryam Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E7-10031 Filed 5-23-07; 8:45 am]
BILLING CODE 4163-18-P
