B- 60 day FRN

emcdonald on DSK67QTVN1PROD with NOTICES

49758

Federal Register / Vol. 78, No. 158 / Thursday, August 15, 2013 / Notices

immediate global public health
response.
WHO must rely on fast and reliable
laboratory diagnostic capacity
worldwide to be able to identify a reemergence of smallpox, particularly in
countries where systemic orthopoxvirus
infections such as monkeypox, vaccinia
virus infection or cowpox, and other
non-pox viral rash illnesses, such as
chicken pox, may cause clinical
diagnostic confusion.
Over the past 10 years, clinical
virology laboratory diagnostics has been
evolving and increasingly relies on
molecular techniques. This is also true
with laboratory diagnoses of poxvirus
infections. Precise and consistent
identification of orthopoxviruses, in
particular variola viruses, is now
achievable using such molecular
techniques as real-time Polymerase
Chain Reaction (PCR), unlike earlier
techniques that may have relied on
direct virus isolation and identification.
WHO must be alerted when there is
a potential or actual smallpox infection.
Early detection and confirmation of
smallpox cannot rely solely on the two
WHO Collaborating Centres for
smallpox and other poxvirus infections.
In order to facilitate and support a
prompt and effective response to
mitigate the spread of the disease, these
two Centres should be supported by a
worldwide network of reliable
laboratories able to perform PCR and
real-time PCR diagnostics enabling
initial detection and identification of
smallpox events.
Additionally, the U.S. Government
supports the development of other
medical products, including vaccines
and drugs, for use within the U.S. upon
verification of a smallpox case. The U.S.
Government, through the Office of the
Assistant Secretary for Preparedness
and Response (ASPR), has successfully
developed vaccine products, and is
actively engaged in the development of
several drug candidates for smallpox
therapies, which require access to the
Variola virus to satisfy regulatory
requirements for product approvals.
Justification: WHO is the only eligible
applicant; it is the only organization
that is allowed by international
agreements to address the issues
outlined in this proposal. WHO is the
directing and coordinating authority for
health within the United Nations (U.N.)
system. It is responsible for providing
leadership on global health matters,
shaping the health research agenda,
setting norms and standards,
articulating evidence-based policy
options, providing technical support to
countries, and monitoring and assessing
health trends. In the 21st century, health

VerDate Mar<15>2010

17:43 Aug 14, 2013

Jkt 229001

is a shared responsibility, involving
equitable access to essential care and
collective defense against transnational
threats. States Parties to the U.N. have
agreed to international standards on
reporting public health incidents of
concern under IHR (2005). Additionally,
a majority of States Parties have also
agreed to specific work-frames for
pathogens such as smallpox under the
Biological Weapons Convention.
Since May 1999, when the 52nd
World Health Assembly (WHA) resolved
to postpone the destruction of the
Variola virus to allow for essential
research (WHA 52.10), WHO has been
charged with convening a group of
experts to advise on the need for
continuing such research, to review
proposals for research involving viable
Variola virus, to review the progress of
such research, and to report to the WHA
each year. The need to support the
activities described in this project has
not changed. In fact, WHO Member
States continue to exert pressure for the
WHO Secretariat to carry out this work.
The WHO Advisory Committee on
Variola Virus Research (ACVVR) was
established in 1999 to determine what
essential research, if any, must be
carried out with live Variola virus. The
ACVVR monitored the research progress
in order to reach global consensus on
the timing for the destruction of existing
Variola virus stocks. In 2007, the WHA
requested the ACVVR undertake a
thorough review of the approved
research program with a report
presented in 2010. The results were
presented at the 64th WHA meeting in
May of 2011. The ACVVR continues to
serve a critically important function for
global public health, and to oversee
research requested specifically by the
U.S. to complete its national strategic
goals. This includes convening a group
of experts, the Advisory Committee on
Variola Virus Research (ACVVR), to
advise on the need for continuing such
research, to review proposals for
research involving viable Variola virus,
and to review the progress of such
research.
Additional Information: The agency
program contact is George Korch, who
can be contacted by phone at (202) 690–
5760 or via email at
[email protected].
Dated: August 12, 2013.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2013–19854 Filed 8–14–13; 8:45 am]
BILLING CODE 4150–37–P

PO 00000

Frm 00037

Fmt 4703

Sfmt 4703

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–13–0010]

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 404–639–7570 or send
comments to Leroy Richardson, at 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
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
Birth Defects Study To Evaluate
Pregnancy exposureS (BD–STEPS)
(formerly titled The National Birth
Defects Prevention Study (NBDPS)),
(OMB 0920–0010, Expiration 04/30/
2015)—Revision—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and
genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects
currently covering three counties in
Metropolitan Atlanta.
Since 1997, CDC has funded casecontrol studies of major birth defects
that utilize existing birth defect

E:\FR\FM\15AUN1.SGM

15AUN1

49759

Federal Register / Vol. 78, No. 158 / Thursday, August 15, 2013 / Notices
surveillance registries (including
MACDP) to identify cases and study
birth defects causes in participating
states/municipalities across the United
States.
BD–STEPS is a case-control study that
is similar to the previous CDC-funded
birth defects case-control study, NBDPS,
which stopped interviewing
participants in 2013. As with NBDPS,
control infants will be randomly
selected from birth certificates or birth
hospital records; mothers of case and
control infants will be interviewed
using a computer-assisted telephone
interview.
The BD–STEPS interview takes
approximately forty-five minutes to
complete. A maximum of 275
interviews are planned per year per
center, 200 cases and 75 controls. With

seven centers planned, the maximum
interview burden for all centers
combined would be approximately
1,444 hours. As with NBDPS, parents in
BD–STEPS will be asked to collect
deoxyribonucleic acid (DNA) samples
from themselves and their infants. The
collection of saliva cells by the mother,
father and infant takes about 15 minutes
per person. For the infant sample, the
parent will rub long-handled sponges
between the infant’s cheek and gum;
parents will be asked to swab a total of
5 sponges per infant. The infant’s
mother and father will be asked to
provide their own saliva samples by
spitting into a funnel connected to small
collection tubes. Collection of the saliva
samples takes approximately 2–5
minutes per person, but the estimate of
burden is 15 minutes per person to

account for reading and understanding
the consent form and specimen
collection instructions and mailing back
the completed kits. The anticipated
maximum burden for collection of the
saliva samples for all centers combined
would be approximately 1,444 hours.
Information gathered from both the
interviews and the DNA specimens has
been and will continue to be used to
study independent genetic and
environmental factors as well as geneenvironment interactions for a broad
range of carefully classified birth
defects.
This request is submitted to obtain
OMB clearance for three additional
years.
There are no costs to the respondents
other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Avg. burden
per response
(in hours)

Total burden
hours

Form name

Mothers (interview) ...........................

1,925

1

45/60

1,444

Mothers, fathers, infants (saliva samples).

Telephone consent and BD–STEPS
questionnaire.
Written consent for saliva collection
and collection of saliva samples.

5,775

1

15/60

1,444

TOTAL .......................................

...........................................................

........................

........................

........................

2,888

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–19839 Filed 8–14–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Request for Nominations of
Candidates to Serve on the Board of
Scientific Counselors, National Center
for Environmental Health/Agency for
Toxic Substances and Disease
Registry (BSC, NCEH/ATSDR)

emcdonald on DSK67QTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Type of respondents

The Centers for Disease Control and
Prevention (CDC) is soliciting
nominations for membership on the
BSC, NCEH/ATSDR. The BSC, NCEH/
ATSDR consists of 16 experts
knowledgeable in the field of
environmental public health or in
related disciplines, who are selected by
the Secretary of the U.S. Department of
Health and Human Services (HHS). The
BSC, NCEH/ATSDR provides advice
and guidance to the Secretary, HHS; the

VerDate Mar<15>2010

17:43 Aug 14, 2013

Jkt 229001

Director, CDC; and the Director, NCEH/
ATSDR, regarding program goals,
objectives, strategies, and priorities in
fulfillment of the agencies’ mission to
protect and promote people’s health.
The Board provides advice and
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the Board’s
objectives. Nominees will be selected
from experts having experience in
preventing human diseases and
disabilities caused by environmental
conditions. Experts in the disciplines of
toxicology, epidemiology,
environmental or occupational
medicine, behavioral science, risk
assessment, exposure assessment, and
experts in public health and other
related disciplines will be considered.
Members may be invited to serve up to
four-year terms.
The HHS policy stipulates that
committee membership be balanced in
terms of points of view represented and
the board’s function. Consideration is
given to a broad representation of
geographic areas within the U.S., as well
as gender, race, ethnicity, persons with

PO 00000

Frm 00038

Fmt 4703

Sfmt 4703

disabilities, and several factors
including: (1) The committee’s mission;
(2) the geographic, ethnic, social,
economic, or scientific impact of the
advisory committee’s recommendations;
(3) the types of specific perspectives
required, for example, those of
consumers, technical experts, the public
at-large, academia, business, or other
sectors; (4) the need to obtain divergent
points of view on the issues before the
advisory committee; and (5) the
relevance of State, local, or tribal
governments to the development of the
advisory committee’s recommendations.
Nominees must be U.S. citizens.
The following information must be
submitted for each candidate: Name,
affiliation, address, telephone number,
and current curriculum vitae. Email
addresses are requested if available.
Nominations should be sent, in writing,
and postmarked by September 30, 2013,
to: Sandra Malcom, Committee
Management Specialist, NCEH/ATSDR,
CDC, 4770 Buford Highway, NE.,
Mailstop F61, Atlanta, Georgia 30341,
Email address: [email protected].
Telephone and facsimile submissions
cannot be accepted.
Candidates invited to serve will be
asked to submit the ‘‘Confidential
Financial Disclosure Form (OGE Form
450) for Special Government Employees

E:\FR\FM\15AUN1.SGM

15AUN1