Agency Information Collection Activities: Proposed Collection: Public Comment Request, 62636-62637 [2014-24870]
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Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
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guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 19,
2014.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Heather Longstaff, Center for Veterinary
Medicine (HFV–145), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0651,
email: heather.longstaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry (GFI #227)
entitled ‘‘Two-Phased Chemistry,
Manufacturing, and Controls (CMC)
Technical Sections.’’ It is intended to
provide recommendations to industry
regarding CMC data submitted to CVM
to support approval of a new animal
drug or abbreviated new animal drug.
As specified in the Animal Drug User
Fee Amendments of 2013 (ADUFA III)
and Animal Generic Drug User Fee
Amendments of 2013 (AGDUFA II)
respective goals letters, the Agency
agreed to develop guidance for a twophased CMC technical section
submission and review process by the
end of fiscal year 2014.
The two-phased process allows for
two separate CMC submissions, each
with its own review clock, and each
including complete appropriate CMC
information that is available for review
at the time of submission. The draft
guidance specifies the technical details
of how the process works, the review
clocks, the information that is
appropriate for each technical section
submission, and the possible review
outcomes. The guidance also includes
CVM’s recommendations for meetings
between the Division of Manufacturing
Technologies and the sponsor during
this process to ensure concurrence with
the approach used for the CMC
technical section.
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II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in this guidance have
been approved under 0910–0032 and
0910–0669.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24796 Filed 10–17–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
AGENCY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than December 19, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Secretary’s Discretionary Advisory
Committee on Heritable Disorders in
Newborns and Children’s Public Health
System Assessment Surveys OMB No.
0915-xxxx–New
Abstract: The purpose of the public
health system assessment surveys is to
inform the Secretary’s Discretionary
Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee) on the ability to add
newborn screening for particular
conditions within a state, including the
feasibility, readiness, and overall
capacity to screen for a new condition.
The Committee was established under
the Public Health Service Act, 42 U.S.C.
217a: Advisory Councils or Committees.
This Committee fulfills the functions
previously undertaken by the former
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children, established under Section
1111 of the Public Health Service Act
(PHS), 42 U.S.C. 300b–10, as amended
in the Newborn Screening Saves Lives
Act of 2008. The Committee is governed
by the provisions of the Federal
Advisory Committee Act (FACA), as
SUMMARY:
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Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of advisory committees. The
purpose of the Committee is to provide
the Secretary with recommendations,
advice, and technical information
regarding the most appropriate
application of technologies, policies,
guidelines, and standards for: (a)
Effectively reducing morbidity and
mortality in newborns and children
having, or at risk for, heritable
disorders; and (b) enhancing the ability
of state and local health agencies to
provide for newborn and child
screening, counseling, and health care
services for newborns and children
having, or at risk for, heritable
disorders. Specifically, the Committee
makes systematic evidence-based
recommendations on newborn screening
for conditions that have the potential to
change the health outcomes for
newborns.
The Committee tasks an external
workgroup to conduct systematic
evidence based reviews. The reviews are
of rare, genetic conditions and their
corresponding newborn screening
test(s), confirmatory test(s), and
treatment(s). Reviews also include an
analysis of the benefits and harms of
newborn screening for a selected
condition at a population level and an
assessment of state public health
newborn screening programs’ ability to
implement the screening of a new
condition.
Need and Proposed Use of the
Information: HRSA proposes that the
data collection surveys be administered
by the Committee’s external Condition
Review Workgroup to all state newborn
screening programs in the United States.
The surveys were developed to capture
the following: (1) The readiness of state
public health newborn screening
programs to expand newborn screening
to include the target condition; (2)
specific requirements of screening for
the condition would hinder or facilitate
its implementation in each state; and (3)
estimated timeframes needed for each
state to complete major milestones
toward full newborn screening of the
condition.
The data gathered will inform the
Committee on the following: (1)
Feasibility of implementing populationbased screening for the target condition;
(2) readiness of state newborn screening
programs to adopt screening for the
condition; (3) identify gaps in feasibility
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
INITIAL Survey .....................................................................
FOLLOW-UP Survey ...........................................................
1 30
1
1
59
30
10.0
2.0
590
60
Total ..............................................................................
59
........................
89
........................
650
1 Up
to 30 states and/or territories will be asked to complete a follow-up survey.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
tkelley on DSK3SPTVN1PROD with NOTICES
59
or readiness to screen for the condition;
and (4) identify areas of technical
assistance and resources needed to
facilitate screening for conditions with
low feasibility or readiness.
Likely Respondents: The respondents
to the survey will be state newborn
screening programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Dated: October 10, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–24870 Filed 10–17–14; 8:45 am]
BILLING CODE 4165–15–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than November 19,
2014.
Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
ADDRESSES:
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]]>Agencies
[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62636-62637]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24870]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
no later than December 19, 2014.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: The Secretary's Discretionary
Advisory Committee on Heritable Disorders in Newborns and Children's
Public Health System Assessment Surveys OMB No. 0915-xxxx-New
Abstract: The purpose of the public health system assessment
surveys is to inform the Secretary's Discretionary Advisory Committee
on Heritable Disorders in Newborns and Children (Committee) on the
ability to add newborn screening for particular conditions within a
state, including the feasibility, readiness, and overall capacity to
screen for a new condition.
The Committee was established under the Public Health Service Act,
42 U.S.C. 217a: Advisory Councils or Committees. This Committee
fulfills the functions previously undertaken by the former Secretary's
Advisory Committee on Heritable Disorders in Newborns and Children,
established under Section 1111 of the Public Health Service Act (PHS),
42 U.S.C. 300b-10, as amended in the Newborn Screening Saves Lives Act
of 2008. The Committee is governed by the provisions of the Federal
Advisory Committee Act (FACA), as
[[Page 62637]]
amended (5 U.S.C. App.), which sets forth standards for the formation
and use of advisory committees. The purpose of the Committee is to
provide the Secretary with recommendations, advice, and technical
information regarding the most appropriate application of technologies,
policies, guidelines, and standards for: (a) Effectively reducing
morbidity and mortality in newborns and children having, or at risk
for, heritable disorders; and (b) enhancing the ability of state and
local health agencies to provide for newborn and child screening,
counseling, and health care services for newborns and children having,
or at risk for, heritable disorders. Specifically, the Committee makes
systematic evidence-based recommendations on newborn screening for
conditions that have the potential to change the health outcomes for
newborns.
The Committee tasks an external workgroup to conduct systematic
evidence based reviews. The reviews are of rare, genetic conditions and
their corresponding newborn screening test(s), confirmatory test(s),
and treatment(s). Reviews also include an analysis of the benefits and
harms of newborn screening for a selected condition at a population
level and an assessment of state public health newborn screening
programs' ability to implement the screening of a new condition.
Need and Proposed Use of the Information: HRSA proposes that the
data collection surveys be administered by the Committee's external
Condition Review Workgroup to all state newborn screening programs in
the United States. The surveys were developed to capture the following:
(1) The readiness of state public health newborn screening programs to
expand newborn screening to include the target condition; (2) specific
requirements of screening for the condition would hinder or facilitate
its implementation in each state; and (3) estimated timeframes needed
for each state to complete major milestones toward full newborn
screening of the condition.
The data gathered will inform the Committee on the following: (1)
Feasibility of implementing population-based screening for the target
condition; (2) readiness of state newborn screening programs to adopt
screening for the condition; (3) identify gaps in feasibility or
readiness to screen for the condition; and (4) identify areas of
technical assistance and resources needed to facilitate screening for
conditions with low feasibility or readiness.
Likely Respondents: The respondents to the survey will be state
newborn screening programs.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized burden hours:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
INITIAL Survey.................. 59 1 59 10.0 590
FOLLOW-UP Survey................ \1\ 30 1 30 2.0 60
-------------------------------------------------------------------------------
Total....................... 59 .............. 89 .............. 650
----------------------------------------------------------------------------------------------------------------
\1\ Up to 30 states and/or territories will be asked to complete a follow-up survey.
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Dated: October 10, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-24870 Filed 10-17-14; 8:45 am]
BILLING CODE 4165-15-P
