80 FR 50015 - Agency Information Collection Activities; Proposed Collection; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 159 (August 18, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 159 (August 18, 2015)
| Page Range | 50015-50016 | |
| FR Document | 2015-20357 |
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)] [Notices] [Pages 50015-50016] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] or by calling (202) 690-6162. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, [email protected] 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
![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50015
MD 20993–002, 301–796–5333, email: new drug applications (INDs) to CBER submissions for studies that start after
ronald.fitzmartin@fda.hhs.gov. or CDER by specifying the format for March 15, 2018. The Catalog will list
SUPPLEMENTARY INFORMATION: electronic submissions. The initial March 15, 2018, as the ‘‘date
timetable for the implementation of requirement begins.’’ When multiple
I. Background electronic submission requirements for versions of an FDA-supported standard
On December 17, 2014, FDA study data is December 17, 2016 (24 are listed in the Catalog, sponsors or
published a final guidance for industry months after issuance of final guidance applicants can select a version to use.
entitled ‘‘Providing Regulatory for NDAs, BLAs, ANDAs, and 36
Submissions in Electronic Format— months for INDs). The eStudy Data II. Exceptions
Standardized Study Data’’ (eStudy Data) guidance states that a Federal Register
posted on FDA’s Study Data Standards notice will specify the transition date The following SDTM IG 3.2 domains
Resources Web page at http:// for all version updates (with the month have not completed testing and
www.fda.gov/forindustry/ and day for the transition date acceptance and are not supported at this
datastandards/studydatastandards/ corresponding to March 15). time: Death Details and Exposure as
default.htm. The eStudy Data guidance The transition date for support (see Collected. The therapeutic area (TA)
implements the electronic submission section II. Exceptions) of the 3.2 version standards (http://www.cdisc.org/) that
requirements of section 745A(a) of the of CDISC STDM IG is March 15, 2017. are included in SDTM IG 3.2 have not
FD&C Act (21 U.S.C. 379k–1) for study Although SDTM IG version 3.2 is completed testing and acceptance and
data contained in new drug applications supported as of this Federal Register are not supported at this time. The
(NDAs), abbreviated new drug notice and sponsors or applicants are specific domain and the TA standard
applications (ANDAs), biologics license encouraged to begin using it, the new are listed in the table that follows:
applications (BLAs), and investigational version will only be required in
SDTM IG 3.2 Domain TA User guide
1. Healthcare Encounters ............... Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Asthma, 1.0.
2. Microscopic Findings .................. Tuberculosis, 1.0; Parkinson’s, 1.0.
3. Morphology ................................. Cardiovascular Studies, 1.0; Parkinson’s, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer’s, 1.0; Multiple
Sclerosis, 1.0.
4. Procedures .................................. Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer’s, 1.0.
5. Reproductive System .................. Polycystic Kidney Disease, 1.0.
6. Disease Response ...................... Tuberculosis, 1.0.
7. Skin Response ............................ Asthma, 1.0.
Sponsors and applicants with Dated: August 12, 2015. ADDRESSES: Submit your comments to
questions on how to implement the Leslie Kux, Information.CollectionClearance@
FDA-supported study data standards Associate Commissioner for Policy. hhs.gov or by calling (202) 690–6162.
should contact and work with FDA [FR Doc. 2015–20316 Filed 8–17–15; 8:45 am] FOR FURTHER INFORMATION CONTACT:
technical staff. For questions, contact BILLING CODE 4164–01–P Information Collection Clearance staff,
CDER at cder-edata@fda.hhs.gov or Information.CollectionClearance@
CBER at cber.cdisc@fda.hhs.gov. hhs.gov or (202) 690–6162.
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: When
III. Comments HUMAN SERVICES submitting comments or requesting
Interested persons may submit either information, please include the
Office of the Secretary
electronic comments regarding this document identifier HHS–OS–0990–
document to http://www.regulations.gov [Document Identifier: HHS–OS–0990–New– New–60D.
60D]
or written comments to the Division of Information Collection Request Title:
Dockets Management (see ADDRESSES). It Agency Information Collection Evaluation of the Office on Women’s
is only necessary to send one set of Activities; Proposed Collection; Public Health Coalition for a Healthier
comments. Identify comments with the Comment Request Community Initiative
docket number found in brackets in the Abstract: This collection is to provide
heading of this document. Received AGENCY: Office of the Secretary, HHS.
ACTION: Notice. data for the national evaluation of the
comments may be seen in the Division U.S. Department of Health and Human
of Dockets Management between 9 a.m. SUMMARY: In compliance with section Services (HHS), Office on Women’s
and 4 p.m., Monday through Friday, and 3506(c)(2)(A) of the Paperwork Health (OWH) Coalition for a Healthier
will be posted to the docket at http:// Reduction Act of 1995, the Office of the Community (CHC) Initiative. The
www.regulations.gov. Secretary (OS), Department of Health initiative supports 10 communities with
and Human Services, announces plans grants to support coalitions in
IV. Electronic Access
to submit a new Information Collection implementing gender-based public
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Persons with access to the Internet Request (ICR), described below, to the health systems approaches, evidence-
may obtain the proposed Office of Management and Budget based health interventions, and
recommendations at either http:// (OMB). Prior to submitting the ICR to outreach and education activities to
www.fda.gov/forindustry/ OMB, OS seeks comments from the reduce barriers to and enhance
public regarding the burden estimate, facilitators of improvements in women
datastandards/studydatastandards/
below, or any other aspect of the ICR. and girls’ health. Each of the grantees
default.htm or http://
www.regulations.gov. DATES: Comments on the ICR must be has implemented an IRB-approved local
received on or before October 19, 2015. evaluation; however, OWH is seeking to
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![50016 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices
collect core data across grantees to members (including chairs and co- directors and local evaluators also
examine the extent to which the chairs), and community leaders annually provide information to OWH
Government’s investment has resulted connected to the coalitions. These on their coalition’s functioning, the
in achieving OWH-related Healthy respondents will also complete online status of the cost-effectiveness analysis
People 2020 priorities and yields surveys about their perceptions of the for their coalition’s interventions, and
lessons learned upon which to plan changes in their community as a result the coalition’s plans for sustainability.
future initiatives related to its mission. of coalition activities. Program The following table summarizes the
Likely Respondents: The proposed participants and other community ‘‘Total Estimated Annualized Burden—
collection includes plans for interviews members exposed to the coalitions’ Hours’’ by form and type of respondent.
with key staff (project directors, project activities through social media will also
coordinators, local evaluators), coalition complete online surveys. Project
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hrs)
1—Key Persons Discussion Guide for Telephone Interviews ......................... 90 2 1 180
2—Key Persons, Coalition Members, and Community Leaders Online Sur-
vey ................................................................................................................ 200 1 20/60 67
3—Coalition Participants and Other Community Members Online Survey ..... 510 1 20/60 170
4—Grantee Annual Report on Coalition Functioning, Cost-Effectiveness,
and Sustainability Planning .......................................................................... 10 2 2 40
Total .......................................................................................................... ........................ ........................ ........................ 457
OS specifically requests comments on Name of Committee: AIDS Research DEPARTMENT OF HEALTH AND
(1) the necessity and utility of the Advisory Committee, NIAID AIDS Vaccine HUMAN SERVICES
proposed information collection for the Research Subcommittee, NIAID.
proper performance of the agency’s Date: September 22, 2015. National Institutes of Health
functions, (2) the accuracy of the Time: 8:30 a.m. to 5:00 p.m.
estimated burden, (3) ways to enhance Agenda: Presentations by invited speakers National Cancer Institute; Notice of
the quality, utility, and clarity of the to discuss correlates of AIDS vaccine Meeting
information to be collected, and (4) the protection studies in nonhuman primates. In
Pursuant to section 10(d) of the
use of automated collection techniques addition, there will be presentations and
discussion on vaccine-specific HLA–E and
Federal Advisory Committee Act, as
or other forms of information amended (5 U.S.C. App.), notice is
technology to minimize the information class II-restricted CD8+ cells and their role in
nonhuman primate protection observed with
hereby given of a meeting of the
collection burden. National Cancer Advisory Board.
AIDS vaccines based on CMV vectors.
Terry S. Clark, Place: National Institutes of Health, The meeting will be open to the
Conference Room 1D13, 5601 Fishers Lane, public as indicated below, with
Assistant Information Collection Clearance
Rockville, MD 20892. attendance limited to space available.
Officer.
Contact Person: James A. Bradac, Ph.D., Individuals who plan to attend and
[FR Doc. 2015–20357 Filed 8–17–15; 8:45 am]
Executive Secretary, AVRS, Division of AIDS, need special assistance, such as sign
BILLING CODE 4150–33–P
Room 9B60, National Institutes of Health/ language interpretation or other
NIAID, 5601 Fishers Lane, MSC 9829, reasonable accommodations, should
Rockville, MD 20892–9829, 301–435–3754, notify the Contact Person listed below
DEPARTMENT OF HEALTH AND in advance of the meeting.
jbradac@mail.nih.gov.
HUMAN SERVICES A portion of the meeting will be
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
closed to the public in accordance with
National Institutes of Health the provisions set forth in sections
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
National Institute of Allergy and
Research, National Institutes of Health, HHS) as amended. The grant applications and
Infectious Diseases; Notice of Meeting
the discussions could disclose
Dated: August 13, 2015. confidential trade secrets or commercial
Pursuant to section 10(a) of the
Melanie J. Gray, property such as patentable material,
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory and personal information concerning
hereby given of a meeting of the AIDS Committee Policy. individuals associated with the grant
Research Advisory Committee, NIAID. [FR Doc. 2015–20330 Filed 8–17–15; 8:45 am] applications, the disclosure of which
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4140–01–P
would constitute a clearly unwarranted
The meeting will be open to the invasion of personal privacy.
public, with attendance limited to space
available. Individuals who plan to Name of Committee: National Cancer
Advisory Board.
attend and need special assistance, such Date: September 16, 2015.
as sign language interpretation or other Open: 1:00 p.m. to 2:00 p.m.
reasonable accommodations, should Agenda: Director’s report and business of
notify the Contact Person listed below the Board.
in advance of the meeting. Closed: 2:00 p.m. to 3:00 p.m.
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Document Created: 2015-12-15 12:04:48
Document Modified: 2015-12-15 12:04:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the ICR must be received on or before October 19, 2015. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 80 FR 50015 |
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