Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 88246-88247 [2016-29361]
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88246
Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
(Human papillomavirus 9-valent
Vaccine, Recombinant). GARDASIL 9 is
indicated in girls and women 9 through
26 years of age for the prevention of the
following diseases:
• Cervical, vulvar, vaginal, and anal
cancer caused by Human
Papillomavirus (HPV) types 16, 18, 31,
33, 45, 52, and 58.
• Genital warts caused by HPV types
6 and 11.
And the following precancerous or
dysplastic lesions caused by HPV types
6, 11, 16, 18, 31, 33, 45, 52, and 58:
• Cervical intraepithelial neoplasia
(CIN) grade 2/3 and cervical
adenocarcinoma in situ.
• CIN grade 1.
• Vulvar intraepithelial neoplasia
(VIN) grade 2 and grade 3.
• Vaginal intraepithelial neoplasia
(VaIN) grade 2 and grade 1.
• Anal intraepithelial neoplasia (AIN)
grades 1, 2, and 3.
Gardasil 9 is also indicated in boys and
men 9 through 26 years for the
prevention of the following diseases;
• Anal cancer caused by HPV types
16, 18, 31, 33, 45, 52 and 58.
• Genital warts caused by HPV types
6 and 11.
And the following precancerous or
dysplastic lesions caused by HPV types
6, 11, 16, 18, 31, 33, 45, 52, and 58:
• AIN grades 1, 2, and 3.
Subsequent to this approval, the
USPTO received patent term restoration
applications for GARDASIL 9 (U.S.
Patent Nos. 7,476,389 and 7,482,015)
from Merck Sharp & Dohme Corp. for
CSL Limited and The University of
Queensland; the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated April 26,
2016, FDA advised the USPTO that this
human biological product had
undergone a regulatory review period
and that the approval of GARDASIL 9
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
GARDASIL 9 is 2,662 days. Of this time,
2,296 days occurred during the testing
phase of the regulatory review period,
while 366 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
VerDate Sep<11>2014
17:54 Dec 06, 2016
Jkt 241001
became effective: August 29, 2007. The
applicant claims September 2, 2007, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 29, 2007,
which was the first date after receipt of
the IND that the investigational studies
were allowed to proceed.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): December 10, 2013. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for GARDASIL 9 (BLA 125508/0) was
initially submitted on December 10,
2013.
3. The date the application was
approved: December 10, 2014. FDA has
verified the applicant’s claim that BLA
125508/0 was approved on December
10, 2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,062 days or 1,254
days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any
interested person may petition FDA for
a determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
Nos. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–29303 Filed 12–6–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0937–0191–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
number 0937–0191, scheduled to expire
on December 31, 2016. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before January 6, 2017.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–5683.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 0937–0191–30D for
reference.
Information Collection Request Title:
Application packets for Real Property
for Public Health Purposes.
OMB No.: 0937–0191.
Abstract: The Office of Assistant
Secretary for Administration, Program
Support Center, Federal Property
Assistance Program is requesting OMB’s
approval on a previously approved
information collection, 0937–0191. The
Federal Property and Administrative
Services Act of 1949 (P.L. 81–152), as
amended, provides authority to the
Secretary of Health and Human Services
to convey or lease surplus real property
to States and their political subdivisions
and instrumentalities, to tax-supported
institutions, and to nonprofit
institutions which (except for
institutions which lease property to
assist the homeless) have been held
SUMMARY:
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Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Notices
exempt from taxation under Section
501(c)(3) of the 1954 Internal Revenue
Code, and 501(c)(19) for veterans
organizations, for public health and
homeless assistance purposes. Transfers
are made to transferees at little or no
cost.
Need and Proposed Use of the
Information: State and local
governments and non-profit institutions
use these applications to apply for
excess/surplus, underutilized/
unutilized and off-site government real
property. These applications are used to
determine if institutions/organizations
are eligible to purchase, lease or use
property under the provisions of the
surplus real property program.
Likely Respondents: State, local, or
tribal units of government or
instrumentalities thereof; not-for-profit
organizations
The total annual burden hours
estimated for this ICR are summarized
in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Applications for surplus Federal real property .................................................
15
1
200
3,000
Total ..........................................................................................................
15
1
200
3,000
Darius Taylor,
Information Collection Clearance Officer.
When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0990–
New–60D for reference.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–29361 Filed 12–6–16; 8:45 am]
BILLING CODE 4150–04–P
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
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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 February 6, 2017.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–5683.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.funn@hhs.gov
or (202) 690–5683.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Information Collection Request Title:
Domestic Violence Housing First
Demonstration Evaluation
Abstract: The Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) within the U.S. Department of
Health and Human Services, in
partnership with the Office for Victims
of Crimes within the U.S. Department of
Justice, is seeking approval by OMB for
a new information collection request
entitled, ‘‘Domestic Violence Housing
First (DVHF) Demonstration
Evaluation.’’ The Washington State
Coalition Against Domestic Violence
(WSCADV) is overseeing and
coordinating an evaluation of the DVHF
Demonstration project through a
contract with ASPE. This quasiexperimental research study involves
longitudinally examining the program
effects of DVHF on domestic violence
survivors’ safety and housing stability.
The findings will be of interest to the
general public, to policy-makers, and to
organizations working with domestic
violence survivors.
Data collection will include in-depth,
private interviews with 320 domestic
violence survivors conducted by trained
professional staff. At Time 1 study
enrollment, they will be interviewed
about their backgrounds, housing and
safety obstacles, and services desired.
There will be three follow-up interviews
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with them every six months after the
Time 1 Interview (i.e., 6, 12, and 18
months) to examine the match between
needs and services, as well as their
safety and housing stability. Study
enrollment will take place over 15
months, so the annualized burden for
the Time 1 and follow-up surveys is
based on 12/15 (256) of the expected
sample (320).
The primary service providers
working with the domestic violence
survivors will complete selfadministered online questionnaires to
provide more detailed program
implementation data. Service providers
will complete a survey about their work
history and demographics and a survey
about the services provided for each
domestic violence survivor in their
caseload that is a participant in the
study (approximately 16 survivors per
provider). This latter data collection
will occur six months after a domestic
violence survivor enrolls in the study
over 15 months to correspond to the
study enrollment period. Finally, the
study will also include monthly data
collection for 19 months from an agency
point of contact (POC) in order to verify
agency information (e.g., the number of
advocates working in the agency,
advocate caseloads, dates of study
participants’ receipt of services).
Likely Respondents: The respondents
are domestic violence survivors,
primary service providers, and
community agency points of contact
who work with their agency data
systems.
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[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Notices]
[Pages 88246-88247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29361]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-0937-0191-30D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, has submitted an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB) for review and approval. The ICR is for renewal of the approved
information collection assigned OMB control number 0937-0191, scheduled
to expire on December 31, 2016. Comments submitted during the first
public review of this ICR will be provided to OMB. OMB will accept
further comments from the public on this ICR during the review and
approval period.
DATES: Comments on the ICR must be received on or before January 6,
2017.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-5683.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the OMB control number 0937-0191-30D for
reference.
Information Collection Request Title: Application packets for Real
Property for Public Health Purposes.
OMB No.: 0937-0191.
Abstract: The Office of Assistant Secretary for Administration,
Program Support Center, Federal Property Assistance Program is
requesting OMB's approval on a previously approved information
collection, 0937-0191. The Federal Property and Administrative Services
Act of 1949 (P.L. 81-152), as amended, provides authority to the
Secretary of Health and Human Services to convey or lease surplus real
property to States and their political subdivisions and
instrumentalities, to tax-supported institutions, and to nonprofit
institutions which (except for institutions which lease property to
assist the homeless) have been held
[[Page 88247]]
exempt from taxation under Section 501(c)(3) of the 1954 Internal
Revenue Code, and 501(c)(19) for veterans organizations, for public
health and homeless assistance purposes. Transfers are made to
transferees at little or no cost.
Need and Proposed Use of the Information: State and local
governments and non-profit institutions use these applications to apply
for excess/surplus, underutilized/unutilized and off-site government
real property. These applications are used to determine if
institutions/organizations are eligible to purchase, lease or use
property under the provisions of the surplus real property program.
Likely Respondents: State, local, or tribal units of government or
instrumentalities thereof; not-for-profit organizations
The total annual burden hours estimated for this ICR are summarized
in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Applications for surplus Federal real property.. 15 1 200 3,000
---------------------------------------------------------------
Total....................................... 15 1 200 3,000
----------------------------------------------------------------------------------------------------------------
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2016-29361 Filed 12-6-16; 8:45 am]
BILLING CODE 4150-04-P
