Proposed Data Collections Submitted for Public Comment and Recommendations, 73774-73775 [E5-7260]
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Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices
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
Assisted Reproductive Technology
(ART) Program Reporting System—
Extension—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 102–493
(known as the Fertility Clinic Success
Rate and Certification Act of 1992
(FCSRCA), 42 U.S.C. 263a–1(a)) requires
that each ART program shall annually
report to the Secretary through the
Centers for Disease Control and
Prevention—(1) pregnancy success rates
achieved by such ART program, and (2)
the identity of each embryo laboratory
used by such ART program and whether
the laboratory is certified or has applied
for such certification under this Act.
The Act defines ART as all treatments
and procedures that include the
handling of human oocytes and sperm
or embryos for the purpose of
establishing a pregnancy.
The Centers for Disease Control and
Prevention seeks to extend approval of
a reporting system for the Assisted
Reproductive Technology (ART)
Program from the Office of Management
and Budget (OMB) for a period of 3
years. The reporting system includes all
ART cycles initiated by any of the
approximately 400 ART programs in the
United States, and covers the pregnancy
outcome of each cycle as well as a
number of data items deemed important
to explain variability in success rates
across ART programs and across
individuals. An ART cycle is started
when a woman begins taking
medication to stimulate the ovaries to
develop eggs or starts ovarian
monitoring with the intent of having
embryos transferred. Data will be
collected through a Web-based data
collection system, developed by Westat
in consultation with CDC, that complies
with FCSRCA requirements.
In developing the definition of
pregnancy success rates and the list of
data items to be reported, CDC has
consulted with representatives of the
Society for Assisted Reproductive
Technology (SART), the American
Society for Reproductive Medicine
(ASRM), and RESOLVE, the National
Infertility Association (a national,
nonprofit consumer organization), as
well as a variety of individuals with
expertise and interest in this field. The
average annual cost to each ART
program responding to the survey,
including data entry and validation, is
estimated to be $6,720.
Estimated Annualized Burden Table
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hrs.)
ART Programs (data entry) .............................................................................................
ART Programs (selected for data validation) ..................................................................
*400
**40
*288
**83
37/60
23/60
71,040
1,273
Total ..........................................................................................................................
....................
....................
....................
72,313
Respondents
Total burden
(in hours)
*Approximately 400 ART programs (respondents) reported data in 2002. The average number of ART cycles (responses) per ART program
was 288.
**Approximately 10% of the ART programs are selected for validation. An average of 83 ART cycles per ART program were selected for validation in 2002.
Dated: December 7, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7258 Filed 12–12–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers For Disease Control and
Prevention
[60Day–06–06AI]
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
VerDate Aug<31>2005
00:22 Dec 13, 2005
Jkt 208001
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–4766 or send
comments to Seleda Perryman, CDC
Assistant Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an email 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.
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Fmt 4703
Sfmt 4703
Proposed Project
Metropolitan Atlanta Stillbirth
Management Survey: Knowledge,
Attitudes and Practice Patterns from
Obstetricians, new collection, National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The U.S. Congress House Report 108–
792 (joint conference report for the
Fiscal Year 2005 omnibus
appropriations bill) provides specific
funding to devise a comprehensive
strategy for expanding existing birth
defects surveillance systems to
incorporate surveillance data on all
intrauterine fetal deaths of 20 or more
week’s gestation into the Metropolitan
Atlanta Congenital Defects Program
(MACDP). Stillbirth is largely an
understudied adverse pregnancy
outcome even though it accounts for
nearly one half of all perinatal mortality.
There is currently no nationally
E:\FR\FM\13DEN1.SGM
13DEN1
73775
Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices
accepted definition of what constitutes
a stillbirth, and there are no universally
recommended, standardized stillbirth
evaluation protocols in use for the
evaluation of fetal deaths. The proposed
survey has been designed to evaluate
and assess the knowledge, attitudes and
practice management patterns of
obstetricians in the metropolitan Atlanta
area regarding stillbirths in general, as
well as in their medical practice. This
information will be used to identify
prevailing deficiencies leading to
incomplete and inaccurate reporting of
data relative to stillbirths, and to
develop targeted awareness and
educational strategies for participating
MACDP facilities. Ongoing, accurate
and reliable population-based registries
of stillbirths are essential for conducting
epidemiologic studies on the causes of
and risk factors for this pregnancy
outcome. This survey will be mailed to
randomly selected obstetricians whose
practices serve residents of the 5
counties comprising metropolitan
Atlanta. This survey will be conducted
once and will take approximately 2–3
months to collect the data. NCBDDD is
requesting OMB clearance for 1 (one)
year. There is no cost to the survey
respondents except for the time
necessary to complete the survey.
ESTIMATED ANNUALIZED BURDEN TABLE
Respondents
(type)
Respondents
(number)
Obstetricians ............................................................................................
Total ..................................................................................................
Dated: December 7, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7260 Filed 12–12–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0479]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; Butorphanol; Delta–9–
tetrahydrocannabinol (Dronabinol);
Gamma-Hydroxybutyric Acid;
Ketamine; Khat; Tramadol; Zopiclone;
Buprenorphine; Oripavine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
interested persons to submit comments
concerning abuse potential, actual
abuse, medical usefulness, trafficking,
and impact of scheduling changes on
availability for medical use of nine drug
substances. These comments will be
considered in preparing a response from
the United States to the World Health
Organization (WHO) regarding the abuse
liability and diversion of these drugs.
WHO will use this information to
consider whether to recommend that
certain international restrictions be
placed on these drugs. This notice
requesting comments is required by the
Controlled Substances Act (CSA).
DATES: Submit written or electronic
comments by January 12, 2006.
VerDate Aug<31>2005
00:22 Dec 13, 2005
Jkt 208001
600
600
Number of
responses per
respondent
Average burden
per response
(in hrs.)
1
..........................
30/60
..........................
Submit written comments
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:
James R. Hunter, Center for Drug
Evaluation and Research (HFD–9), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–443–
5563, e mail: hunterj@cder.FDA.gov.
SUPPLEMENTARY INFORMATION: The
United States is a party to the 1971
Convention on Psychotropic
Substances. Article 2 of the Convention
on Psychotropic Substances provides
that if a party to the convention or WHO
has information about a substance,
which in its opinion may require
international control or change in such
control, it shall so notify the Secretary
General of the United Nations and
provide the Secretary General of the
United Nations with information in
support of its opinion.
The CSA (21 U.S.C. 811 et seq.) (Title
II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970)
provides that when WHO notifies the
United States under Article 2 of the
Convention on Psychotropic Substances
that it has information that may justify
adding a drug or other substances to one
of the schedules of the convention,
transferring a drug or substance from
one schedule to another, or deleting it
from the schedules, the Secretary of
State must transmit the notice to the
Secretary of the Department of Health
and Human Services (the Secretary of
HHS). The Secretary of HHS must then
publish the notice in the Federal
Register and provide opportunity for
interested persons to submit comments
that will be considered by HHS in its
ADDRESSES:
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Fmt 4703
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Total burden
(in hrs.)
300
300
preparation of the scientific and medical
evaluations of the drug or substance.
I. WHO Notification
The Secretary of HHS received the
following notices from WHO:
Ref: C.L.29.2005
WHO Questionnaire for Collection of
Information for Review of DependenceProducing Psychoactive Substances
The WHO presents its compliments and
has the pleasure of informing Member States
and Associate Members that the Thirty-fourth
Expert Committee on Drug Dependence will
meet from March 28 to 31, 2006 to review the
following substances:
1. Butorphanol (INN)
2. Dronabinol (INN)1
3. Gamma-hydroxybutyric acid
4. Ketamine (INN)
5. Khat (Catha edulis Forsk)
6. Tramadol (INN)
7. Zopiclone (INN)
As a follow-up for the thirty-third meeting
of the Expert Committee on Drug
Dependence, final decisions will be taken for
buprenorphine (INN) and oripavine (INN).
One of the essential elements of the
established review procedure is for the
Secretariat to collect relevant information
from Member States to prepare a Critical
Review Report for submission to the Expert
Committee on Drug Dependence. WHO
invites Member States to collaborate, as in
the past, in this process by providing
pertinent information mentioned in the
attached questionnaire concerning
substances listed above.
Further clarification on any of the above
items can be obtained from Quality
Assurance and Safety: Medicines,
Department of Medicines Policy and
Standards, WHO, Geneva, to which replies
should be sent not later than January 3, 2006.
WHO takes this opportunity to renew to
Member States and Associate Members the
assurance of its highest consideration.
GENEVA, October 27, 2005
*
*
1Including
E:\FR\FM\13DEN1.SGM
*
*
*
its stereo-isomers.
13DEN1
]]>Agencies
[Federal Register Volume 70, Number 238 (Tuesday, December 13, 2005)]
[Notices]
[Pages 73774-73775]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7260]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers For Disease Control and Prevention
[60Day-06-06AI]
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 404-639-4766 or
send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email
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
Metropolitan Atlanta Stillbirth Management Survey: Knowledge,
Attitudes and Practice Patterns from Obstetricians, new collection,
National Center on Birth Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The U.S. Congress House Report 108-792 (joint conference report for
the Fiscal Year 2005 omnibus appropriations bill) provides specific
funding to devise a comprehensive strategy for expanding existing birth
defects surveillance systems to incorporate surveillance data on all
intrauterine fetal deaths of 20 or more week's gestation into the
Metropolitan Atlanta Congenital Defects Program (MACDP). Stillbirth is
largely an understudied adverse pregnancy outcome even though it
accounts for nearly one half of all perinatal mortality. There is
currently no nationally
[[Page 73775]]
accepted definition of what constitutes a stillbirth, and there are no
universally recommended, standardized stillbirth evaluation protocols
in use for the evaluation of fetal deaths. The proposed survey has been
designed to evaluate and assess the knowledge, attitudes and practice
management patterns of obstetricians in the metropolitan Atlanta area
regarding stillbirths in general, as well as in their medical practice.
This information will be used to identify prevailing deficiencies
leading to incomplete and inaccurate reporting of data relative to
stillbirths, and to develop targeted awareness and educational
strategies for participating MACDP facilities. Ongoing, accurate and
reliable population-based registries of stillbirths are essential for
conducting epidemiologic studies on the causes of and risk factors for
this pregnancy outcome. This survey will be mailed to randomly selected
obstetricians whose practices serve residents of the 5 counties
comprising metropolitan Atlanta. This survey will be conducted once and
will take approximately 2-3 months to collect the data. NCBDDD is
requesting OMB clearance for 1 (one) year. There is no cost to the
survey respondents except for the time necessary to complete the
survey.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents (type) Respondents responses per per response Total burden
(number) respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
Obstetricians............................... 600 1 30/60 300
Total................................... 600 ............... ............... 300
----------------------------------------------------------------------------------------------------------------
Dated: December 7, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E5-7260 Filed 12-12-05; 8:45 am]
BILLING CODE 4163-18-P
