Proposed Information Collection Activity; Comment Request, 71736-71737 [2016-25120]
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71736
Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices
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
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 MMR (measles, mumps,
and rubella) and MMRV (measles,
mumps, rubella, and varicella) 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 revised vaccine information
materials entitled ‘‘MMR Vaccine
(Measles, Mumps, and Rubella): What
You Need to Know’’ and ‘‘MMRV
Vaccine (Measles, Mumps, Rubella, and
Varicella): What You Need to Know.’’
Copies of the proposed vaccine
information materials are available at
https://www.regulations.gov (see Docket
Number CDC–2016–0094). 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 13, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2016–25144 Filed 10–17–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Renewal of Office of
Community Services (OCS) Community
Economic Development (CED) Standard
Reporting Format.
OMB No.: 0970–0386.
Description: The Office of Community
Services (OCS) will continue collecting
key information about projects funded
through the Community Economic
Development (CED) program. The
legislative requirement for this program
is in Title IV of the Community
Opportunities, Accountability and
Training and Educational Services Act
(COATS Human Services
Reauthorization Act) of October 27,
1998, Public Law 105–285, section
680(b) as amended. The reporting
format, Performance Progress Report
(PPR), collects information concerning
the outcomes and management of CED
projects. OCS will use the data to
critically review the overall design and
effectiveness of the program.
The PPR will continue to be
administered to all active grantees of the
CED program. Grantees will be required
to use this reporting tool for their semiannual reports to be submitted twice a
year. The current PPR replaced both the
annual questionnaire and other semiannual reporting formats, which
resulted in an overall reduction in
burden for the grantees while
significantly improving the quality of
the data collected by OCS. OCS seeks to
renew this PPR to continue to collect
quality data from grantees. To ensure
the burden on grantees is not increased,
but that the information collected
demonstrates the full impact of the
program, OCS has conducted an indepth review to remove indicators that
are not being used; add indicators that
will allow OCS to better demonstrate
the impact of the program; and clarify
language of some indicators to reduce
grantee confusion. Based on this review,
proposed changes to the CED PPR are
minimal and focused on clarifying
language, removing outdated indicators,
and gathering minimal additional data
that will not increase the burden on
grantees. These measures will result in
a stronger and streamlined CED PPR
that will allow for the following:
—More clarity for grantees and ability to
avoid confusion around what data
should be provided.
—Increased consistency across data.
—Ability for OCS and grantees to better
demonstrate the impact of these
projects.
A summary of all proposed changes
can be provided upon request.
Respondents: Active CED Grantees
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
PPR for Current OCS–CED Grantees .............................................................
Lhorne on DSK30JT082PROD with NOTICES
Instrument
170
2
1.5
510
Estimated Total Annual Burden
Hours:
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
VerDate Sep<11>2014
13:19 Oct 17, 2016
Jkt 241001
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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
E:\FR\FM\18OCN1.SGM
18OCN1
Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices
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. 2016–25120 Filed 10–17–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3118]
Mallinckrodt Pharmaceuticals;
Proposal To Withdraw Approval of an
Abbreviated New Drug Application for
Extended-Release Methylphenidate
Tablets; Opportunity for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of an abbreviated new drug
application (ANDA) for
methylphenidate hydrochloride (HCl)
extended-release (ER) tablets and is
announcing an opportunity for the
holder of the ANDA to request a hearing
on this proposal.
DATES: Mallinckrodt Pharmaceuticals
may submit a request for a hearing by
November 17, 2016. Submit all data,
information, and analyses upon which
the request for a hearing relies by
December 19, 2016. Submit written or
electronic comments by December 19,
2016.
ADDRESSES: The request for a hearing
may be submitted by Mallinckrodt
Pharmaceuticals by either of the
following methods:
Lhorne on DSK30JT082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
13:19 Oct 17, 2016
Jkt 241001
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
any attachments to the request for
hearing, will be posted to the docket
unchanged.
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.
• Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request does not include any
confidential information that you may
not wish to be publicly posted, such as
confidential business information, e.g., a
manufacturing process. The request for
a hearing must include the Docket No.
FDA–2016–N–3118 for ‘‘Mallinckrodt
Pharmaceuticals; Proposal to Withdraw
Approval of an Abbreviated New Drug
Application for Extended-Release
Methylphenidate Tablets; Opportunity
for a Hearing.’’ The request for a hearing
will be placed in the docket and
publicly viewable at https://
www.regulations.gov or at the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Mallinckrodt Pharmaceuticals may
submit all data and analysis upon which
the request for a hearing relies in the
same manner as the request for a
hearing except as follows:
• Confidential Submissions—To
submit any data analyses with
confidential information that you do not
wish to be made publicly available,
submit your data and analyses only as
a written/paper submission. You should
submit two copies total of all data and
analyses. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of any decisions on
this matter. The second copy, which
will have the claimed confidential
information redacted/blacked out, will
be available for public viewing and
posted on https://www.regulations.gov or
available at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday. Submit both
copies to the Division of Dockets
Management. Any information marked
as ‘‘confidential’’ will not be disclosed
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
71737
except in accordance with 21 CFR 10.20
and other applicable disclosure law.
Comments Submitted by Other
Interested Parties: For all comments
submitted by other interested parties,
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,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–3118 for ‘‘Mallinckrodt
Pharmaceuticals; Proposal to Withdraw
Approval of an Abbreviated New Drug
Application for Extended-Release
Methylphenidate Tablets; Opportunity
for a Hearing.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
E:\FR\FM\18OCN1.SGM
18OCN1
Agencies
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Notices]
[Pages 71736-71737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25120]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Renewal of Office of Community Services (OCS) Community
Economic Development (CED) Standard Reporting Format.
OMB No.: 0970-0386.
Description: The Office of Community Services (OCS) will continue
collecting key information about projects funded through the Community
Economic Development (CED) program. The legislative requirement for
this program is in Title IV of the Community Opportunities,
Accountability and Training and Educational Services Act (COATS Human
Services Reauthorization Act) of October 27, 1998, Public Law 105-285,
section 680(b) as amended. The reporting format, Performance Progress
Report (PPR), collects information concerning the outcomes and
management of CED projects. OCS will use the data to critically review
the overall design and effectiveness of the program.
The PPR will continue to be administered to all active grantees of
the CED program. Grantees will be required to use this reporting tool
for their semi-annual reports to be submitted twice a year. The current
PPR replaced both the annual questionnaire and other semi-annual
reporting formats, which resulted in an overall reduction in burden for
the grantees while significantly improving the quality of the data
collected by OCS. OCS seeks to renew this PPR to continue to collect
quality data from grantees. To ensure the burden on grantees is not
increased, but that the information collected demonstrates the full
impact of the program, OCS has conducted an in-depth review to remove
indicators that are not being used; add indicators that will allow OCS
to better demonstrate the impact of the program; and clarify language
of some indicators to reduce grantee confusion. Based on this review,
proposed changes to the CED PPR are minimal and focused on clarifying
language, removing outdated indicators, and gathering minimal
additional data that will not increase the burden on grantees. These
measures will result in a stronger and streamlined CED PPR that will
allow for the following:
--More clarity for grantees and ability to avoid confusion around what
data should be provided.
--Increased consistency across data.
--Ability for OCS and grantees to better demonstrate the impact of
these projects.
A summary of all proposed changes can be provided upon request.
Respondents: Active CED Grantees
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
PPR for Current OCS-CED Grantees............ 170 2 1.5 510
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours:
In compliance with the requirements of the Paperwork Reduction Act
of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), 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, 330 C Street SW.,
Washington DC 20201. Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
[[Page 71737]]
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. 2016-25120 Filed 10-17-16; 8:45 am]
BILLING CODE 4184-01-P