Agency Information Collection Activities; Proposed Collection; Public Comment Request, 50015-50016 [2015-20357]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices
MD 20993–002, 301–796–5333, email:
ronald.fitzmartin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 17, 2014, FDA
published a final guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Standardized Study Data’’ (eStudy Data)
posted on FDA’s Study Data Standards
Resources Web page at https://
www.fda.gov/forindustry/
datastandards/studydatastandards/
default.htm. The eStudy Data guidance
implements the electronic submission
requirements of section 745A(a) of the
FD&C Act (21 U.S.C. 379k–1) for study
data contained in new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), biologics license
applications (BLAs), and investigational
new drug applications (INDs) to CBER
or CDER by specifying the format for
electronic submissions. The initial
timetable for the implementation of
electronic submission requirements for
study data is December 17, 2016 (24
months after issuance of final guidance
for NDAs, BLAs, ANDAs, and 36
months for INDs). The eStudy Data
guidance states that a Federal Register
notice will specify the transition date
for all version updates (with the month
and day for the transition date
corresponding to March 15).
The transition date for support (see
section II. Exceptions) of the 3.2 version
of CDISC STDM IG is March 15, 2017.
Although SDTM IG version 3.2 is
supported as of this Federal Register
notice and sponsors or applicants are
encouraged to begin using it, the new
version will only be required in
50015
submissions for studies that start after
March 15, 2018. The Catalog will list
March 15, 2018, as the ‘‘date
requirement begins.’’ When multiple
versions of an FDA-supported standard
are listed in the Catalog, sponsors or
applicants can select a version to use.
II. Exceptions
The following SDTM IG 3.2 domains
have not completed testing and
acceptance and are not supported at this
time: Death Details and Exposure as
Collected. The therapeutic area (TA)
standards (https://www.cdisc.org/) that
are included in SDTM IG 3.2 have not
completed testing and acceptance and
are not supported at this time. The
specific domain and the TA standard
are listed in the table that follows:
SDTM IG 3.2 Domain
TA User guide
1. Healthcare Encounters ...............
2. Microscopic Findings ..................
3. Morphology .................................
Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Asthma, 1.0.
Tuberculosis, 1.0; Parkinson’s, 1.0.
Cardiovascular Studies, 1.0; Parkinson’s, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer’s, 1.0; Multiple
Sclerosis, 1.0.
Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer’s, 1.0.
Polycystic Kidney Disease, 1.0.
Tuberculosis, 1.0.
Asthma, 1.0.
4.
5.
6.
7.
Procedures ..................................
Reproductive System ..................
Disease Response ......................
Skin Response ............................
Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Sponsors and applicants with
questions on how to implement the
FDA-supported study data standards
should contact and work with FDA
technical staff. For questions, contact
CDER at cder-edata@fda.hhs.gov or
CBER at cber.cdisc@fda.hhs.gov.
[FR Doc. 2015–20316 Filed 8–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Comments
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the proposed
recommendations at either https://
www.fda.gov/forindustry/
datastandards/studydatastandards/
default.htm or https://
www.regulations.gov.
VerDate Sep<11>2014
17:02 Aug 17, 2015
Jkt 235001
Office of the Secretary
[Document Identifier: HHS–OS–0990–New–
60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit a new Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before October 19, 2015.
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0990–
New–60D.
ADDRESSES:
Information Collection Request Title:
Evaluation of the Office on Women’s
Health Coalition for a Healthier
Community Initiative
Abstract: This collection is to provide
data for the national evaluation of the
U.S. Department of Health and Human
Services (HHS), Office on Women’s
Health (OWH) Coalition for a Healthier
Community (CHC) Initiative. The
initiative supports 10 communities with
grants to support coalitions in
implementing gender-based public
health systems approaches, evidencebased health interventions, and
outreach and education activities to
reduce barriers to and enhance
facilitators of improvements in women
and girls’ health. Each of the grantees
has implemented an IRB-approved local
evaluation; however, OWH is seeking to
E:\FR\FM\18AUN1.SGM
18AUN1
50016
Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices
collect core data across grantees to
examine the extent to which the
Government’s investment has resulted
in achieving OWH-related Healthy
People 2020 priorities and yields
lessons learned upon which to plan
future initiatives related to its mission.
Likely Respondents: The proposed
collection includes plans for interviews
with key staff (project directors, project
coordinators, local evaluators), coalition
members (including chairs and cochairs), and community leaders
connected to the coalitions. These
respondents will also complete online
surveys about their perceptions of the
changes in their community as a result
of coalition activities. Program
participants and other community
members exposed to the coalitions’
activities through social media will also
complete online surveys. Project
directors and local evaluators also
annually provide information to OWH
on their coalition’s functioning, the
status of the cost-effectiveness analysis
for their coalition’s interventions, and
the coalition’s plans for sustainability.
The following table summarizes the
‘‘Total Estimated Annualized Burden—
Hours’’ by form and type of respondent.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hrs)
Total burden
hours
1—Key Persons Discussion Guide for Telephone Interviews .........................
2—Key Persons, Coalition Members, and Community Leaders Online Survey ................................................................................................................
3—Coalition Participants and Other Community Members Online Survey .....
4—Grantee Annual Report on Coalition Functioning, Cost-Effectiveness,
and Sustainability Planning ..........................................................................
90
2
1
180
200
510
1
1
20/60
20/60
67
170
10
2
2
40
Total ..........................................................................................................
........................
........................
........................
457
OS 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.
Terry S. Clark,
Assistant Information Collection Clearance
Officer.
[FR Doc. 2015–20357 Filed 8–17–15; 8:45 am]
BILLING CODE 4150–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the AIDS
Research Advisory Committee, NIAID.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
VerDate Sep<11>2014
17:02 Aug 17, 2015
Jkt 235001
Name of Committee: AIDS Research
Advisory Committee, NIAID AIDS Vaccine
Research Subcommittee, NIAID.
Date: September 22, 2015.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: Presentations by invited speakers
to discuss correlates of AIDS vaccine
protection studies in nonhuman primates. In
addition, there will be presentations and
discussion on vaccine-specific HLA–E and
class II-restricted CD8+ cells and their role in
nonhuman primate protection observed with
AIDS vaccines based on CMV vectors.
Place: National Institutes of Health,
Conference Room 1D13, 5601 Fishers Lane,
Rockville, MD 20892.
Contact Person: James A. Bradac, Ph.D.,
Executive Secretary, AVRS, Division of AIDS,
Room 9B60, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9829,
Rockville, MD 20892–9829, 301–435–3754,
jbradac@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 13, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–20330 Filed 8–17–15; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
A portion of the meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Advisory Board.
Date: September 16, 2015.
Open: 1:00 p.m. to 2:00 p.m.
Agenda: Director’s report and business of
the Board.
Closed: 2:00 p.m. to 3:00 p.m.
Frm 00032
Fmt 4703
Sfmt 4703
E:\FR\FM\18AUN1.SGM
18AUN1
]]>Agencies
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50015-50016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-0990-New-60D]
Agency Information Collection Activities; Proposed Collection;
Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, announces plans to submit a new Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments
from the public regarding the burden estimate, below, or any other
aspect of the ICR.
DATES: Comments on the ICR must be received on or before October 19,
2015.
ADDRESSES: Submit your comments to
Information.CollectionClearance@hhs.gov or by calling (202) 690-6162.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the document identifier HHS-OS-0990-New-
60D.
Information Collection Request Title: Evaluation of the Office on
Women's Health Coalition for a Healthier Community Initiative
Abstract: This collection is to provide data for the national
evaluation of the U.S. Department of Health and Human Services (HHS),
Office on Women's Health (OWH) Coalition for a Healthier Community
(CHC) Initiative. The initiative supports 10 communities with grants to
support coalitions in implementing gender-based public health systems
approaches, evidence-based health interventions, and outreach and
education activities to reduce barriers to and enhance facilitators of
improvements in women and girls' health. Each of the grantees has
implemented an IRB-approved local evaluation; however, OWH is seeking
to
[[Page 50016]]
collect core data across grantees to examine the extent to which the
Government's investment has resulted in achieving OWH-related Healthy
People 2020 priorities and yields lessons learned upon which to plan
future initiatives related to its mission.
Likely Respondents: The proposed collection includes plans for
interviews with key staff (project directors, project coordinators,
local evaluators), coalition members (including chairs and co-chairs),
and community leaders connected to the coalitions. These respondents
will also complete online surveys about their perceptions of the
changes in their community as a result of coalition activities. Program
participants and other community members exposed to the coalitions'
activities through social media will also complete online surveys.
Project directors and local evaluators also annually provide
information to OWH on their coalition's functioning, the status of the
cost-effectiveness analysis for their coalition's interventions, and
the coalition's plans for sustainability. The following table
summarizes the ``Total Estimated Annualized Burden--Hours'' by form and
type of respondent.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response Total burden
respondents respondent (in hrs) hours
----------------------------------------------------------------------------------------------------------------
1--Key Persons Discussion Guide for Telephone 90 2 1 180
Interviews.....................................
2--Key Persons, Coalition Members, and Community 200 1 20/60 67
Leaders Online Survey..........................
3--Coalition Participants and Other Community 510 1 20/60 170
Members Online Survey..........................
4--Grantee Annual Report on Coalition 10 2 2 40
Functioning, Cost-Effectiveness, and
Sustainability Planning........................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 457
----------------------------------------------------------------------------------------------------------------
OS 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.
Terry S. Clark,
Assistant Information Collection Clearance Officer.
[FR Doc. 2015-20357 Filed 8-17-15; 8:45 am]
BILLING CODE 4150-33-P
