82_FR_43569 82 FR 43391 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Poison Help General Population Survey, OMB No. 0915-0343, Reinstatement

82 FR 43391 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Poison Help General Population Survey, OMB No. 0915-0343, Reinstatement

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 178 (September 15, 2017)

Page Range43391-43392
FR Document2017-19608

In compliance with the Paperwork Reduction Act of 1995, 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 of this ICR will be provided to OMB. The ICR is for reinstatement with change of a previously approved information collection assigned OMB control number 0915-0343 that expired on May 31, 2014. OMB will accept further comments from the public during the review and approval period.

Federal Register, Volume 82 Issue 178 (Friday, September 15, 2017) 
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43391-43392]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19608]


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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; Information Collection 
Request Title: Poison Help General Population Survey, OMB No. 0915-
0343, Reinstatement

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, 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 of this ICR will be provided to OMB. The 
ICR is for reinstatement with change of a previously approved 
information collection assigned OMB control number 0915-0343 that 
expired on May 31, 2014. 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 October 
16, 2017.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] 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, Lisa Wright-Solomon, at 
[email protected] or call (301) 443-1984.

[[Page 43392]]


SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference, in compliance with Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995.
    Information Collection Request Title: Poison Help General 
Population Survey OMB Number 0915-0343, Reinstatement.
    Abstract: HRSA is requesting approval by OMB for reinstatement with 
change of a previously approved collection of information (OMB control 
number 0915-0343). Annually, poison control centers (PCCs) in the U.S. 
manage approximately 2.8 million calls, providing ready and direct 
access to vital public health emergency information and response. In 
2001, the Poison Help line, a single, national toll-free phone number 
(800-222-1222) was established to ensure universal access to PCC 
services, 24 hours a day, 7 days a week. The Poison Help campaign is 
the only national media effort to promote awareness and use of the 
national toll-free phone number.
    The Poison Help campaign aims to reach a wide audience, as 
individuals of all ages are at risk for poisoning and may need to 
access PCC services. The ``Poison Help General Population Survey'' is a 
10-minute telephone survey designed to assess the campaign's impact 
among 2,000 households in the United States. The survey is conducted 
with an adult household member and addresses topics related to the 
types of individuals or organizations to contact for information, 
advice, and treatment related to a poisoning.
    Need and Proposed Use of the Information: Survey results will be 
used to guide future communication, education, and outreach efforts and 
will allow the tracking of longitudinal data from near-identical prior 
surveys conducted in 2008 and 2011. The survey has been updated to 
include questions regarding one of the Secretary of HHS' priority 
areas, addressing the opioid crisis, and to definitively ascertain 
respondents' knowledge of the Poison Help Line and phone usage.
    Likely Respondents: This study includes two respondent groups, 
individuals and households with an adult member 18 years and older.
    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 ICR are summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                   Number of      Responses per        Total         Hours per     Total burden
          Instrument              respondents      respondent        responses       response          hours
----------------------------------------------------------------------------------------------------------------
Survey Respondents............            2000                 1            2000            .166             332
Screened households...........            2600                 1            2600            .016            41.6
                               ---------------------------------------------------------------------------------
    Total.....................            4600  ................            4600  ..............             374
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Amy McNulty.
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-19608 Filed 9-14-17; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43391 I. Background II. Significance of Guidance approved under OMB control number FDA is announcing the availability of This draft guidance is being issued 0910–0332. The collections of a draft leapfrog guidance for industry consistent with FDA’s good guidance information in 21 CFR part 820 and FDA staff entitled ‘‘Utilizing practices regulation (21 CFR 10.115). regarding the Quality System regulation Animal Studies to Evaluate Organ The draft guidance, when finalized, will have been approved under OMB control Preservation Devices.’’ The intent of this number 0910–0073. The collections of represent the current thinking of FDA draft guidance is to provide information in the guidance document on ‘‘Utilizing Animal Studies to recommendations regarding best entitled ‘‘Requests for Feedback on Evaluate Organ Preservation Devices.’’ It practices for utilizing animal studies for Medical Device Submissions: The Pre- does not establish any rights for any the evaluation of organ preservation Submission Program and Meetings with person and is not binding on FDA or the devices, with careful considerations of Food and Drug Administration Staff’’ public. You can use an alternative regulatory least burdensome principles, have been approved under OMB control approach if it satisfies the requirements as well as, ethical principles in animal number 0910–0756. of the applicable statutes and testing. This draft guidance provides regulations. This guidance is not subject Dated: September 6, 2017. clarity on premarket recommendations to Executive Order 12866. Anna K. Abram, to develop animal transplant models for Deputy Commissioner for Policy, Planning, organ preservation technologies, which III. Electronic Access Legislation, and Analysis. will streamline initiation of clinical Persons interested in obtaining a copy [FR Doc. 2017–19613 Filed 9–14–17; 8:45 am] studies. Optimizing animal and clinical of the draft guidance may do so by BILLING CODE 4164–01–P study designs for premarket downloading an electronic copy from submissions will allow us to bring novel the internet. A search capability for all organ preservation devices to the market Center for Devices and Radiological DEPARTMENT OF HEALTH AND faster to increase the availability of Health guidance documents is available HUMAN SERVICES organs for transplant for patients at https://www.fda.gov/MedicalDevices/ awaiting transplants. Early stakeholder DeviceRegulationandGuidance/ Health Resources and Services feedback was sought to inform the GuidanceDocuments/default.htm. This Administration development of this draft guidance guidance document is also available at Agency Information Collection through CDRH’s notice on the fiscal year https://www.regulations.gov. Persons Activities: Submission to OMB for 2016 proposed guidance development unable to download an electronic copy Review and Approval; Public Comment issued December 29, 2015 (80 FR of ‘‘Utilizing Animal Studies to Evaluate Request; Information Collection 81335), available at https:// Organ Preservation Devices’’ may send Request Title: Poison Help General www.federalregister.gov/documents/ an email request to CDRH-Guidance@ Population Survey, OMB No. 0915– 2015/12/29/2015-32726/medical-device- fda.hhs.gov to receive an electronic 0343, Reinstatement user-fee-and-modernization-act-notice- copy of the document. Please use the to-public-of-web-site-location-of-fiscal- document number 1500083 to identify AGENCY: Health Resources and Services year#h-14. Specific questions were the guidance you are requesting. Administration (HRSA), Department of posed to solicit input into the context of Health and Human Services (HHS). IV. Paperwork Reduction Act of 1995 the guidance and comments were ACTION: Notice. collected through Docket No. FDA– This draft guidance document refers 2012–N–1021. to previously approved collections of SUMMARY: In compliance with the This draft guidance is a leapfrog information found in FDA regulations Paperwork Reduction Act of 1995, guidance; leapfrog guidances are and guidances. These collections of HRSA has submitted an Information intended to serve as a mechanism by information are subject to review by the Collection Request (ICR) to the Office of which the Agency can share initial Office of Management and Budget Management and Budget (OMB) for thoughts regarding the content of (OMB) under the Paperwork Reduction review and approval. Comments premarket submissions for emerging Act of 1995 (44 U.S.C. 3501–3520). The submitted during the first public review technologies and new clinical collections of information in 21 CFR of this ICR will be provided to OMB. applications that are likely to be of part 58 regarding good laboratory The ICR is for reinstatement with public health importance very early in practices have been approved under change of a previously approved product development. This leapfrog OMB control number 0910–0119. The information collection assigned OMB draft guidance represents the Agency’s collections of information in 21 CFR control number 0915–0343 that expired initial thinking, and our part 801 regarding labeling have been on May 31, 2014. OMB will accept recommendations may change as more approved under OMB control number further comments from the public information becomes available. The 0910–0485. The collections of during the review and approval period. Agency strongly encourages information in 21 CFR part 807, subpart DATES: Comments on this ICR should be manufacturers to engage with CDRH E regarding premarket notification have received no later than October 16, 2017. through the Pre-Submission process to been approved under OMB control ADDRESSES: Submit your comments, obtain more detailed feedback regarding number 0910–0120. The collections of including the ICR Title, to the desk their organ preservation device. For information in 21 CFR part 812 officer for HRSA, either by email to more information on Pre-Submissions, regarding investigational device OIRA_submission@omb.eop.gov or by please see ‘‘Requests for Feedback on exemptions have been approved under fax to 202–395–5806. mstockstill on DSK30JT082PROD with NOTICES Medical Device Submissions: The Pre- OMB control number 0910–0078. The FOR FURTHER INFORMATION CONTACT: To Submission Program and Meetings with collections of information in 21 CFR request a copy of the clearance requests Food and Drug Administration Staff’’ at part 814, subparts A through E regarding submitted to OMB for review, email the (https://www.fda.gov/downloads/ premarket approval have been approved HRSA Information Collection Clearance MedicalDevices/ under OMB control number 0910–0231. Officer, Lisa Wright-Solomon, at DeviceRegulationandGuidance/ The collections of information in 21 paperwork@hrsa.gov or call (301) 443– GuidanceDocuments/UCM311176.pdf). CFR part 814, subpart H have been 1984. VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1

43392 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices SUPPLEMENTARY INFORMATION: When awareness and use of the national toll- opioid crisis, and to definitively submitting comments or requesting free phone number. ascertain respondents’ knowledge of the information, please include the The Poison Help campaign aims to Poison Help Line and phone usage. information request collection title for reach a wide audience, as individuals of Likely Respondents: This study reference, in compliance with Section all ages are at risk for poisoning and includes two respondent groups, 3506(c)(2)(A) of the Paperwork may need to access PCC services. The individuals and households with an Reduction Act of 1995. ‘‘Poison Help General Population adult member 18 years and older. Information Collection Request Title: Survey’’ is a 10-minute telephone Burden Statement: Burden in this Poison Help General Population Survey survey designed to assess the context means the time expended by OMB Number 0915–0343, campaign’s impact among 2,000 persons to generate, maintain, retain, Reinstatement. households in the United States. The disclose, or provide the information Abstract: HRSA is requesting survey is conducted with an adult requested. This includes the time approval by OMB for reinstatement with household member and addresses topics needed to review instructions; to change of a previously approved related to the types of individuals or develop, acquire, install and utilize collection of information (OMB control organizations to contact for information, technology and systems for the purpose number 0915–0343). Annually, poison advice, and treatment related to a of collecting, validating and verifying control centers (PCCs) in the U.S. poisoning. information, processing and manage approximately 2.8 million calls, Need and Proposed Use of the maintaining information, and disclosing providing ready and direct access to Information: Survey results will be used and providing information; to train vital public health emergency to guide future communication, personnel and to be able to respond to information and response. In 2001, the education, and outreach efforts and will a collection of information; to search Poison Help line, a single, national toll- allow the tracking of longitudinal data data sources; to complete and review free phone number (800–222–1222) was from near-identical prior surveys the collection of information; and to established to ensure universal access to conducted in 2008 and 2011. The transmit or otherwise disclose the PCC services, 24 hours a day, 7 days a survey has been updated to include information. The total annual burden week. The Poison Help campaign is the questions regarding one of the Secretary hours estimated for this ICR are only national media effort to promote of HHS’ priority areas, addressing the summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of Responses per Total Hours per Total burden Instrument respondents respondent responses response hours Survey Respondents ........................................................ 2000 1 2000 .166 332 Screened households ...................................................... 2600 1 2600 .016 41.6 Total .......................................................................... 4600 ............................ 4600 ........................ 374 Amy McNulty. FOR FURTHER INFORMATION CONTACT: applications are filed on selected Acting Director, Division of the Executive Licensing information and copies of the inventions to extend market coverage Secretariat. patent applications listed below may be for companies and may also be available [FR Doc. 2017–19608 Filed 9–14–17; 8:45 am] obtained by emailing the indicated for licensing. A description of the BILLING CODE 4165–15–P licensing contact at the National Heart, technology available for licensing Lung, and Blood, Office of Technology follows. Transfer and Development Office of DEPARTMENT OF HEALTH AND Technology Transfer, 31 Center Drive, Methods of Using Inhibitors To HUMAN SERVICES Room 4A29, MSC2479, Bethesda, MD Enhance Therapeutic Uses of 20892–2479; telephone: 301–402–5579. Endocannabinoids National Institutes of Health A signed Confidential Disclosure Description of Technology: The Government-Owned Inventions; Agreement may be required to receive invention pertains to methods of using Availability for Licensing copies of the patent applications. compounds that inhibit fatty acid amide AGENCY: National Institutes of Health, SUPPLEMENTARY INFORMATION: The hydrolase (FAAH) enzymes that are HHS. inventions listed below are owned by an responsible for the degradation of ACTION: Notice. agency of the U.S. Government and are oleamide and anandamide. Inhibition of available for licensing in the U.S. in degradation can be used as treatment SUMMARY: Government owned accordance with 35 U.S.C. 209 and 37 modality for hypertension and for sleep intellectual property covering imaging CFR part 404 to achieve expeditious disorders. The issued patent lists agents with improved renal clearance commercialization of results of potentially useful compounds, one such available for licensing and federally-funded research and useful compound in particular is commercialization. development. Foreign patent mstockstill on DSK30JT082PROD with NOTICES EN15SE.001</GPH> VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\15SEN1.SGM 15SEN1


Document Created: 2017-09-15 00:18:50
Document Modified: 2017-09-15 00:18:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this ICR should be received no later than October 16, 2017.
ContactTo request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer, Lisa Wright-Solomon, at [email protected] or call (301) 443-1984.
FR Citation82 FR 43391 
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