81 FR 88246 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 81, Issue 235 (December 7, 2016)
Office of the Secretary
Federal Register Volume 81, Issue 235 (December 7, 2016)
| Page Range | 88246-88247 | |
| FR Document | 2016-29361 |
[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)] [Notices] [Pages 88246-88247] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] or via facsimile to (202) 395-5806. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, [email protected] 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
![88246 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Notices
(Human papillomavirus 9-valent became effective: August 29, 2007. The DEPARTMENT OF HEALTH AND
Vaccine, Recombinant). GARDASIL 9 is applicant claims September 2, 2007, as HUMAN SERVICES
indicated in girls and women 9 through the date the investigational new drug
26 years of age for the prevention of the application (IND) became effective. Office of the Secretary
following diseases: However, FDA records indicate that the [Document Identifier: HHS–OS–0937–0191–
• Cervical, vulvar, vaginal, and anal IND effective date was August 29, 2007, 30D]
cancer caused by Human which was the first date after receipt of
Papillomavirus (HPV) types 16, 18, 31, the IND that the investigational studies Agency Information Collection
33, 45, 52, and 58. were allowed to proceed. Activities; Submission to OMB for
• Genital warts caused by HPV types Review and Approval; Public Comment
6 and 11. 2. The date the application was Request
And the following precancerous or initially submitted with respect to the
dysplastic lesions caused by HPV types human biological product under section AGENCY: Office of the Secretary, HHS.
6, 11, 16, 18, 31, 33, 45, 52, and 58: 351 of the Public Health Service Act (42 ACTION: Notice.
• Cervical intraepithelial neoplasia U.S.C. 262): December 10, 2013. FDA
has verified the applicant’s claim that SUMMARY: In compliance with section
(CIN) grade 2/3 and cervical 3507(a)(1)(D) of the Paperwork
adenocarcinoma in situ. the biologics license application (BLA)
for GARDASIL 9 (BLA 125508/0) was Reduction Act of 1995, the Office of the
• CIN grade 1. Secretary (OS), Department of Health
• Vulvar intraepithelial neoplasia initially submitted on December 10,
2013. and Human Services, has submitted an
(VIN) grade 2 and grade 3.
Information Collection Request (ICR),
• Vaginal intraepithelial neoplasia 3. The date the application was described below, to the Office of
(VaIN) grade 2 and grade 1. approved: December 10, 2014. FDA has
• Anal intraepithelial neoplasia (AIN) Management and Budget (OMB) for
verified the applicant’s claim that BLA review and approval. The ICR is for
grades 1, 2, and 3. 125508/0 was approved on December renewal of the approved information
Gardasil 9 is also indicated in boys and 10, 2014. collection assigned OMB control
men 9 through 26 years for the
This determination of the regulatory number 0937–0191, scheduled to expire
prevention of the following diseases;
review period establishes the maximum on December 31, 2016. Comments
• Anal cancer caused by HPV types submitted during the first public review
potential length of a patent extension.
16, 18, 31, 33, 45, 52 and 58. of this ICR will be provided to OMB.
• Genital warts caused by HPV types However, the USPTO applies several
statutory limitations in its calculations OMB will accept further comments from
6 and 11. the public on this ICR during the review
of the actual period for patent extension.
And the following precancerous or and approval period.
In its applications for patent extension,
dysplastic lesions caused by HPV types DATES: Comments on the ICR must be
6, 11, 16, 18, 31, 33, 45, 52, and 58: this applicant seeks 1,062 days or 1,254
days of patent term extension. received on or before January 6, 2017.
• AIN grades 1, 2, and 3. ADDRESSES: Submit your comments to
Subsequent to this approval, the III. Petitions OIRA_submission@omb.eop.gov or via
USPTO received patent term restoration
Anyone with knowledge that any of facsimile to (202) 395–5806.
applications for GARDASIL 9 (U.S.
Patent Nos. 7,476,389 and 7,482,015) the dates as published are incorrect may FOR FURTHER INFORMATION CONTACT:
from Merck Sharp & Dohme Corp. for submit either electronic or written Information Collection Clearance staff,
CSL Limited and The University of comments and ask for a redetermination Information.CollectionClearance@
Queensland; the USPTO requested (see DATES). Furthermore, any hhs.gov or (202) 690–5683.
FDA’s assistance in determining the interested person may petition FDA for SUPPLEMENTARY INFORMATION: When
patents’ eligibility for patent term a determination regarding whether the submitting comments or requesting
restoration. In a letter dated April 26, applicant for extension acted with due information, please include the OMB
2016, FDA advised the USPTO that this diligence during the regulatory review control number 0937–0191–30D for
human biological product had period. To meet its burden, the petition reference.
undergone a regulatory review period must be timely (see DATES) and contain Information Collection Request Title:
and that the approval of GARDASIL 9 sufficient facts to merit an FDA Application packets for Real Property
represented the first permitted investigation. (See H. Rept. 857, part 1, for Public Health Purposes.
commercial marketing or use of the 98th Cong., 2d sess., pp. 41–42, 1984.) OMB No.: 0937–0191.
product. Thereafter, the USPTO Petitions should be in the format Abstract: The Office of Assistant
requested that FDA determine the specified in 21 CFR 10.30. Secretary for Administration, Program
product’s regulatory review period. Support Center, Federal Property
Submit petitions electronically to Assistance Program is requesting OMB’s
II. Determination of Regulatory Review http://www.regulations.gov at Docket approval on a previously approved
Period Nos. FDA–2013–S–0610. Submit written information collection, 0937–0191. The
FDA has determined that the petitions (two copies are required) to the Federal Property and Administrative
applicable regulatory review period for Division of Dockets Management (HFA– Services Act of 1949 (P.L. 81–152), as
GARDASIL 9 is 2,662 days. Of this time, 305), Food and Drug Administration, amended, provides authority to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
2,296 days occurred during the testing 5630 Fishers Lane, Rm. 1061, Rockville, Secretary of Health and Human Services
phase of the regulatory review period, MD 20852. to convey or lease surplus real property
while 366 days occurred during the Dated: December 1, 2016. to States and their political subdivisions
approval phase. These periods of time and instrumentalities, to tax-supported
Leslie Kux,
were derived from the following dates: institutions, and to nonprofit
1. The date an exemption under Associate Commissioner for Policy. institutions which (except for
section 505(i) of the Federal Food, Drug, [FR Doc. 2016–29303 Filed 12–6–16; 8:45 am] institutions which lease property to
and Cosmetic Act (21 U.S.C. 355(i)) BILLING CODE 4164–01–P assist the homeless) have been held
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![Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Notices 88247
exempt from taxation under Section governments and non-profit institutions Likely Respondents: State, local, or
501(c)(3) of the 1954 Internal Revenue use these applications to apply for tribal units of government or
Code, and 501(c)(19) for veterans excess/surplus, underutilized/ instrumentalities thereof; not-for-profit
organizations, for public health and unutilized and off-site government real organizations
homeless assistance purposes. Transfers property. These applications are used to The total annual burden hours
are made to transferees at little or no determine if institutions/organizations
estimated for this ICR are summarized
cost. are eligible to purchase, lease or use
in the table below.
Need and Proposed Use of the property under the provisions of the
Information: State and local surplus real property program.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)
Applications for surplus Federal real property ................................................. 15 1 200 3,000
Total .......................................................................................................... 15 1 200 3,000
Darius Taylor, SUPPLEMENTARY INFORMATION: When with them every six months after the
Information Collection Clearance Officer. submitting comments or requesting Time 1 Interview (i.e., 6, 12, and 18
[FR Doc. 2016–29361 Filed 12–6–16; 8:45 am] information, please include the months) to examine the match between
BILLING CODE 4150–04–P document identifier HHS–OS–0990– needs and services, as well as their
New–60D for reference. safety and housing stability. Study
Information Collection Request Title: enrollment will take place over 15
DEPARTMENT OF HEALTH AND Domestic Violence Housing First months, so the annualized burden for
HUMAN SERVICES Demonstration Evaluation the Time 1 and follow-up surveys is
based on 12/15 (256) of the expected
Office of the Secretary Abstract: The Office of the Assistant sample (320).
Secretary for Planning and Evaluation
[Document Identifier: HHS–OS–0990–New– The primary service providers
(ASPE) within the U.S. Department of
60D] working with the domestic violence
Health and Human Services, in
survivors will complete self-
partnership with the Office for Victims
Agency Information Collection administered online questionnaires to
of Crimes within the U.S. Department of
Activities; Proposed Collection; Public provide more detailed program
Justice, is seeking approval by OMB for
Comment Request implementation data. Service providers
a new information collection request
will complete a survey about their work
AGENCY: Office of the Secretary, HHS. entitled, ‘‘Domestic Violence Housing
history and demographics and a survey
ACTION: Notice. First (DVHF) Demonstration
about the services provided for each
Evaluation.’’ The Washington State
Coalition Against Domestic Violence domestic violence survivor in their
SUMMARY: In compliance with section caseload that is a participant in the
3506(c)(2)(A) of the Paperwork (WSCADV) is overseeing and
coordinating an evaluation of the DVHF study (approximately 16 survivors per
Reduction Act of 1995, the Office of the provider). This latter data collection
Secretary (OS), Department of Health Demonstration project through a
contract with ASPE. This quasi- will occur six months after a domestic
and Human Services, announces plans violence survivor enrolls in the study
to submit a new Information Collection experimental research study involves
longitudinally examining the program over 15 months to correspond to the
Request (ICR), described below, to the study enrollment period. Finally, the
Office of Management and Budget effects of DVHF on domestic violence
survivors’ safety and housing stability. study will also include monthly data
(OMB). Prior to submitting the ICR to collection for 19 months from an agency
OMB, OS seeks comments from the The findings will be of interest to the
general public, to policy-makers, and to point of contact (POC) in order to verify
public regarding the burden estimate, agency information (e.g., the number of
below, or any other aspect of the ICR. organizations working with domestic
violence survivors. advocates working in the agency,
DATES: Comments on the ICR must be advocate caseloads, dates of study
Data collection will include in-depth,
received on or before February 6, 2017. private interviews with 320 domestic participants’ receipt of services).
ADDRESSES: Submit your comments to violence survivors conducted by trained Likely Respondents: The respondents
Information.CollectionClearance@ professional staff. At Time 1 study are domestic violence survivors,
hhs.gov or by calling (202) 690–5683. enrollment, they will be interviewed primary service providers, and
FOR FURTHER INFORMATION CONTACT: about their backgrounds, housing and community agency points of contact
Sherrette Funn, Sherrette.funn@hhs.gov safety obstacles, and services desired. who work with their agency data
asabaliauskas on DSK3SPTVN1PROD with NOTICES
or (202) 690–5683. There will be three follow-up interviews systems.
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Document Created: 2016-12-07 05:31:24
Document Modified: 2016-12-07 05:31:24
| 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 January 6, 2017. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-5683. | |
| FR Citation | 81 FR 88246 |
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