15162 Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
study should no longer continue perfluorinated compounds; cotinine;
Estimated Total Annual Burden
because it is not a good use of tax
Hours: 540. and phytoestrogens. A growing body of
Additional Information: Copies of the dollars. literature suggests these compounds
5 CFR 1320.5 (General Requirements)
proposed collection may be obtained by may exert adverse effects on human
Reporting and Recordkeeping
writing to the Administration for reproduction and development;
Requirements: Final Rule requires that
Children and Families, Office of however, definitive data are lacking
the agency inform the potential persons
Administration, Office of Information especially for sensitive endpoints.
who are to respond to the collection of
Services, 370 L鈥橢nfant Promenade, SW., Couples will participate in a 25-minute
information that such persons are not
Washington, DC 20447, Attn: ACF baseline interview and be instructed in
required to respond to the collection of
Reports Clearance Officer. All requests the use of home fertility monitors and
information unless it displays a
should be identified by the title of the pregnancy kits for counting the time
currently valid OMB control number.
information collection. Email address: required for pregnancy and detecting
This information is required to be stated
infocollection@acf.hhs.gov. pregnancy. Blood and urine samples
OMB Comment: OMB is required to in the 30-day Federal Register Notice. will be collected at baseline from both
Proposed Collection: Title:
make a decision concerning the partners of the couple for measurement
Longitudinal Investigation of Fertility
collection of information between 30 of the environmental exposures. Two
and the Environment (LIFE Study). Type
and 60 days after publication of this
semen samples from male partners and
of Information Collection Request:
document in the Federal Register.
two saliva samples from female partners
EXTENSION (OMB control number
Therefore, a comment is best assured of
also will be requested. Semen samples
0925鈥?0543, expiration date, March 30,
having its full effect if OMB receives it
will be used to globally assess male
2008). Need and Use of Information
within 30 days of publication. Written
fecundity as measured primarily by
Collection: The purpose of the LIFE
comments and recommendations for the
sperm concentration and morphology.
Study is to assess the impact of
proposed information collection should
Saliva samples will be used for the
environmental factors, broadly defined
be sent directly to the following: Office
measurement of cortisol levels as a
to include lifestyle factors, on human
of Management and Budget, Paperwork
marker of stress among female partners
reproduction and development. The
Reduction Project, Fax: 202鈥?395鈥?6974,
so that the relation between
LIFE Study is consistent with the
Attn: Desk Officer for the
environmental factors, stress and human
mission of the Eunice Kennedy Shriver
Administration for Children and
reproduction can be assessed. The
National Institute of Child Health and
Families.
findings will provide valuable
Human Development that includes
Dated: March 14, 2008. information regarding the effect of
conducting basic, clinical and
Janean Chambers, environmental contaminants on
epidemiologic research focusing on
sensitive markers of human
Reports Clearance Officer.
factors and processes associated with
reproduction and development, filling
[FR Doc. E8鈥?5656 Filed 3鈥?20鈥?08; 8:45 am] human reproduction and development
critical data gaps. Moreover, these
thereby, ensuring the birth of healthy
BILLING CODE 4184鈥?01鈥揗
environmental exposures will be
infants capable of reaching full adult
analyzed in the context of other lifestyle
potential unimpaired by physical or
DEPARTMENT OF HEALTH AND exposures such as use of cigarettes and
mental disabilities. This study will
HUMAN SERVICES alcohol, consistent with the manner in
assess the relation between select
which human beings are exposed.
environmental factors and human
National Institutes of Health Frequency of Response: Following the
reproduction and development. This
baseline interview (25 minutes), couples
research originally proposed to recruit
Submission for OMB Review;
will each complete a 2-minute daily
960 couples who are interested in
Comment Request; Longitudinal
diary on select lifestyle factors. Women
becoming pregnant and willing to
Investigation of Fertility and the
will perform daily fertility testing (7
participate in a longitudinal study.
Environment
minutes) approximately 11 days per
Fewer than expected couples were
cycle and pregnancy testing (4 minutes)
Under the provisions of
SUMMARY: enrolled during the first three years of
at day of expected menses using a
Section 3507(a)(1)(D) of the Paperwork the project (n = 350), predominantly due
dipstick test in urine. Approximately
Reduction Act of 1995, the Eunice to the fact that more couples were
60% of women will become pregnant
Kennedy Shriver National Institute of ineligible for participation than had
after 2 to 3 months, at which point they
Child Health and Human Development, been originally estimated. In light of this
will switch to the less intensive portion
the National Institutes of Health has fact, the revised study plan is to enroll
of the protocol. Men will provide two
submitted to the Office of Management a total of 500 couples (i.e., 150
semen samples, a month apart, requiring
and Budget (OMB) a request for renewal additional couples), a sample size that
approximately 20 minutes for each
of an information collection request. will not compromise the main study
collection, and women will collect two
The original information collection objectives. Couples will be selected
saliva samples, a month apart, requiring
request was approved (OMB Clearance from geographic regions that were
approximately 6 minutes each.
0925鈥?0543) following publication in the chosen from peer reviewed competitive
Participating couples will be given a
Federal Register on January 9, 2004, proposals. Fecundity will be measured
choice to submit their information by
page 1589 and December 2, 2004, page by the time required for the couples to
mail or to send it electronically to the
70153. The proposed collection achieve pregnancy, while fertility will
Data Coordinating Center. This option
extension was previously published in be measured by the ability of couples to
will be available throughout data
the Federal Register on January 16, have a live born infant. Infertility will
mstockstill on PROD1PC66 with NOTICES
collection in the event couples change
2008, page 2925 and allowed 60 days for be recognized for couples unable to
their minds about how they would like
public comment. Only one public conceive within 12 months of trying.
to submit information. Study
comment was received during the The study鈥檚 primary environmental
participants will collect semen and
previous comment period. It was exposures include: Organochlorine
saliva samples and forward them in
received via e-mail from a concerned pesticides; polychlorinated biphenyls;
prepaid delivery packages to the study鈥檚
citizen who stated that she felt that the polybrominated diphenyl ethers; metals;
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15163
Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
Clinical Trial Registry, as described in
laboratories. Research nurses will to obtain a copy of the data collection
Public Law 110鈥?85.
collect blood and urine samples and plans and instruments, contact: Dr.
This information collection is
return them to the study鈥檚 laboratories. Germaine M. Buck Louis, Epidemiology
essential to the effective stewardship of
Affected Public: Individuals from Branch, Division of Epidemiology,
Federal Funds. After consultation with
participating communities. Type of Statistics & Prevention Research,
other agencies and NIH components,
Respondents: Men aged 18+ years and NICHD, 6100 Executive Blvd., Room
NIH has determined that the
women aged 18鈥?40 years. Estimated 7B03, Rockville, MD 20852, 301鈥?496鈥?
information is not currently available in
Number of Respondents: Approximately 6155. You may also e-mail your request
any single, reliable, accessible source.
500 couples enrolling (minimum of 400 to louisg@mail.nih.gov.
Proposed Collection: Title:
completing the study). Estimated Comments Due Date: Comments
Information Program on Clinical Trials
Number of Response Sets Per regarding this information collection are
for Serious and Life-Threatening
Respondent: 7 per woman and 4 per best assured of having their full effect if
Diseases: Maintaining a Databank; Type
man over approximately two years. received within 30 days of the date of
of Information Collection Request: New;
Average Burden Hours Per Response: (1) this publication.
Form Number: NA; Need and Use of
0.17 hours for completing the screening Dated: March 12, 2008.
Information Collection: In compliance
instrument; (2) 0.42 hours for baseline
Paul L. Johnson, with provisions of Title VIII of Public
interviews with men and women; (3) 2.5
Project Clearance Liaison, The Eunice Law 110鈥?85 (Food and Drug
hours for daily journal while attempting
Kennedy Shriver National Institute of Child Administration Amendments Act of
pregnancy for men and women; (4) 0.38 Health and Human Development, National
2007) the National Institutes of Health is
and 0.7 hours for biospecimen Institutes of Health.
modifying the clinical trial registry
collection for women and men, [FR Doc. E8鈥?5700 Filed 3鈥?20鈥?08; 8:45 am]
established under previous law
respectively; (5) 2.6 hours for fertility
BILLING CODE 4140鈥?01鈥揚 [ClinicalTrials.gov, established in
monitors; (6) 0.27 hours for pregnancy
response to FDAMA, Section 113]. The
testing for women; and (7) 0.29 hours
registry collects specified information
for pregnancy journals for women. DEPARTMENT OF HEALTH AND on certain clinical trials identified in the
Estimated Total Annual Burden Hours HUMAN SERVICES law, with the objective of enhancing
Requested: 1,640 to 4,950 hours for
patient enrollment and providing a
female participants and 1,050 to 2,740 National Institutes of Health
mechanism for tracking subsequent
hours for male participants depending
progress of clinical trials, to the benefit
upon the length of time required for Submission for OMB Emergency
of public health. The registry is widely
pregnancy. There is no cost to Review; Comment Request;
used by patients, physicians, and
respondents. There are no Capital Costs, Information Program on Clinical Trials
medical researchers, in particular those
Operating Costs, and/or Maintenance for Serious and Life-Threatening
involved in clinical research studies.
Costs to report. Diseases: Maintaining a Databank
Public Law 110鈥?85 expands the scope
Request for Comments: Written
Summary: In accordance with Section of clinical trials that must be registered
comments and/or suggestions from the
3507(j) of the Paperwork Reduction Act in ClinicalTrials.gov to include certain
public and affected agencies are invited
of 1995, the National Institutes of Health defined clinical trials of drugs,
on one or more of the following points:
hereby publishes notification of an biologics, and devices subject to FDA
(1) Evaluate whether the proposed
Emergency Clearance for the expansion regulation, regardless of whether they
collection of information is necessary
of the information related to the are related to serious or life-threatening
for the proper performance of the
鈥樷?業nformation Program on Clinical Trials diseases. It also increases the clinical
function of the agency, including
for Serious and Life-Threatening trial information (i.e., number of data
whether the information will have
Diseases: Maintaining a Databank.鈥欌?? The elements) that must be submitted as part
practical utility; (2) Evaluate the
expanded program will include of each registration.
accuracy of the agency鈥檚 estimate of the
Frequency of Response: Responsible
information on certain clinical trials of
burden of the proposed collection of
parties for applicable clinical trials must
drugs, biologics, and devices, whether
information, including the validity of
submit the required information shortly
or not they relate to serious and life-
the methodology and assumptions used;
after the initiation of a trial [by the later
threatening diseases.
(3) Enhance the quality, utility, and
The information collection is essential of 21 days after the first patient is
clarity of the information to be
to the mission of the FDA and National enrolled or December 26, 2007].
collected; and (4) Minimize the burden
Institutes of Health [42 U.S.C. Updates to registration records are
of the collection of information on those
282(j)(2)(A)(ii)] and is critical to meeting thereafter required at least once a year,
who are to respond, including the use
their roles in the Clinical Trial Registry unless there are no changes to report.
of appropriate automated, electronic,
that was expanded by Public Law 110鈥? Changes in recruitment status and
mechanical, or other technological
85, which was enacted on September completion of a trial must be reported
collection techniques or other forms of
27, 2007. not later than 30 days after such events.
information technology.
NIH cannot reasonably comply with Records for trials that were ongoing (as
Direct Comments to OMB: Written
the normal clearance procedures for defined in the Law) as of December 26,
comments and/or suggestions regarding
information collection, because the use
the item(s) contained in this notice, 2007 are also required to be updated to
of normal procedures will delay the
especially regarding the estimated comply with the new registration data
collection and hinder the agency in
public burden and associated response elements, even if they were previously
accomplishing its mission and meeting
time, should be directed to the: Office registered.
mstockstill on PROD1PC66 with NOTICES
Description of Respondents:
new statutory requirements, to the
of Management and Budget, Office of
Respondents are referred to in the law
detriment of the public good.
Regulatory Affairs,
as 鈥樷?榬esponsible parties.鈥欌?? The statute
Compelling reason exists for the
OIRA_submission@omb.eop.gov, or by
defines the responsible party as: (1) The
collection of required information for
fax to 202鈥?395鈥?6974, Attention: Desk
sponsor of the clinical trial (as defined
successful planning and
Officer for NIH. To request more
in 21 CFR 50.3) or (2) the principal
implementation of the expansion of the
information on the proposed project or
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