Proposed Information Collection Activity; Comment Request, 61819-61820 [2015-25998]
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Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
[FR Doc. 2015–26012 Filed 10–13–15; 8:45 am]
Mailstop A–19, 1600 Clifton Road NE.,
Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
docket number. All relevant comments
received will be posted without change
to https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Skip
Wolfe (crw4@cdc.gov), National Center
for Immunization and Respiratory
Diseases, Centers for Disease Control
and Prevention, Mailstop A–19, 1600
Clifton Road, NE., Atlanta, Georgia
30329.
BILLING CODE 6820–EP–P
SUPPLEMENTARY INFORMATION:
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 9000–0076,
Novation/Change of Name
Requirements, in all correspondence.
Edward Loeb,
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0059]
Proposed Revised Vaccine Information
Materials for Meningococcal ACWY
and Serogroup B Meningococcal
Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), the Centers for
Disease Control and Prevention (CDC)
within the Department of Health and
Human Services (HHS) develops
vaccine information materials that all
health care providers are required to
give to patients/parents prior to
administration of specific vaccines.
HHS/CDC seeks written comment on the
proposed updated vaccine information
statements for meningococcal ACWY
and serogroup B meningococcal
vaccines.
SUMMARY:
Written comments must be
received on or before December 14,
2015.
DATES:
You may submit comments,
identified by Docket No. CDC–2015–
0059, by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Written comments should be
addressed to Suzanne Johnson-DeLeon,
National Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention,
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ADDRESSES:
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The
National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by
section 708 of Public Law 103–183,
added section 2126 to the Public Health
Service Act. Section 2126, codified at 42
U.S.C. 300aa–26, requires the Secretary
of Health and Human Services to
develop and disseminate vaccine
information materials for distribution by
all health care providers in the United
States to any patient (or to the parent or
legal representative in the case of a
child) receiving vaccines covered under
the National Vaccine Injury
Compensation Program (VICP).
Development and revision of the
vaccine information materials, also
known as Vaccine Information
Statements (VIS), have been delegated
by the Secretary to the Centers for
Disease Control and Prevention (CDC).
Section 2126 requires that the materials
be developed, or revised, after notice to
the public, with a 60-day comment
period, and in consultation with the
Advisory Commission on Childhood
Vaccines, appropriate health care
provider and parent organizations, and
the Food and Drug Administration. The
law also requires that the information
contained in the materials be based on
available data and information, be
presented in understandable terms, and
include:
(1) A concise description of the
benefits of the vaccine,
(2) A concise description of the risks
associated with the vaccine,
(3) A statement of the availability of
the National Vaccine Injury
Compensation Program, and
(4) Such other relevant information as
may be determined by the Secretary.
The vaccines initially covered under
the National Vaccine Injury
Compensation Program were diphtheria,
tetanus, pertussis, measles, mumps,
rubella and poliomyelitis vaccines.
Since April 15, 1992, any health care
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61819
provider in the United States who
intends to administer one of these
covered vaccines is required to provide
copies of the relevant vaccine
information materials prior to
administration of any of these vaccines.
Since then, the following vaccines have
been added to the National Vaccine
Injury Compensation Program, requiring
use of vaccine information materials for
them as well: Hepatitis B, Haemophilus
influenzae type b (Hib), varicella
(chickenpox), pneumococcal conjugate,
rotavirus, hepatitis A, meningococcal,
human papillomavirus (HPV), and
seasonal influenza vaccines.
Instructions for use of the vaccine
information materials are found on the
CDC Web site at: https://www.cdc.gov/
vaccines/hcp/vis/.
HHS/CDC is proposing updated
versions of the meningococcal ACWY
and serogroup B meningococcal vaccine
information statements.
The vaccine information materials
referenced in this notice are being
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, and parent and health
care provider groups.
We invite written comment on the
proposed vaccine information materials
entitled ‘‘Meningococcal ACWY
Vaccines (MenACWY and MPSV4):
What You Need to Know’’ and
‘‘Serogroup B Meningococcal Vaccine
(MenB): What You Need to Know.’’
Copies of the proposed vaccine
information materials are available at
https://www.regulations.gov (see Docket
Number CDC–2015–0059).Comments
submitted will be considered in
finalizing these materials. When the
final materials are published in the
Federal Register, the notice will include
an effective date for their mandatory
use.
Dated: October 7, 2015.
Sandra Cashman,
Acting Director, Division of the Executive
Secretariat, Office of the Chief of Staff,
Centers for Disease Control and Prevention.
[FR Doc. 2015–26076 Filed 10–13–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Annual Survey of Refugees
(Form ORR–9)
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61820
Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
OMB No.: 0970–0033
Description: The Annual Survey of
Refugees collects information on the
social and economic characteristics of a
random sample of refugees, Amerasians,
and entrants who arrived in the United
States in the five years prior to the date
of the survey. The survey focuses on
employment and other training, labor
force participation, and welfare
utilization rates. From the responses,
the Office of Refugee Resettlement
reports on the economic adjustment of
refugees to the American economy.
These data are used by Congress in its
annual deliberations on refugee
admissions and funding and by program
managers in formulating policies for the
future direction of the Refugee
Resettlement Program.
Respondents: Refugees, Amerasians,
and entrants
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average burden hours per
response
Total burden
hours
ORR–9 Annual Survey of Refugees ...............................................................
Request for Participation Letter .......................................................................
2,000
2,000
1
1
0.62
0.05
1,240
100
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
1,340
tkelley on DSK3SPTVN1PROD with NOTICES
In compliance with the requirements
of section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–25998 Filed 10–13–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3419]
General Considerations for Animal
Studies for Medical Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘General
Considerations for Animal Studies for
Medical Devices.’’ FDA has developed
this guidance document to assist
industry in designing evaluation
strategies for, and reporting the results
of, animal studies for medical devices.
The intent of this draft guidance is to
provide a reference of best practices for
the approach to, and conduct of, animal
studies, and the presentation of animal
study data intended to demonstrate that
the device under study is sufficiently
safe for early human experience (e.g., to
support an investigational device
exemption (IDE) application) or to
demonstrate device safety in support of
a marketing application, while
incorporating modern animal care and
use strategies. This draft guidance is not
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by January 12,
2016.
SUMMARY:
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ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
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[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61819-61820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25998]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Annual Survey of Refugees (Form ORR-9)
[[Page 61820]]
OMB No.: 0970-0033
Description: The Annual Survey of Refugees collects information on
the social and economic characteristics of a random sample of refugees,
Amerasians, and entrants who arrived in the United States in the five
years prior to the date of the survey. The survey focuses on employment
and other training, labor force participation, and welfare utilization
rates. From the responses, the Office of Refugee Resettlement reports
on the economic adjustment of refugees to the American economy. These
data are used by Congress in its annual deliberations on refugee
admissions and funding and by program managers in formulating policies
for the future direction of the Refugee Resettlement Program.
Respondents: Refugees, Amerasians, and entrants
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ORR-9 Annual Survey of Refugees................. 2,000 1 0.62 1,240
Request for Participation Letter................ 2,000 1 0.05 100
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 1,340
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements of section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments 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) 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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-25998 Filed 10-13-15; 8:45 am]
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