Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43391 

I. Background 

FDA is announcing the availability of 

a draft leapfrog guidance for industry 

and FDA staff entitled ‘‘Utilizing 

Animal Studies to Evaluate Organ 

Preservation Devices.’’ The intent of this 

draft guidance is to provide 

recommendations regarding best 

practices for utilizing animal studies for 

the evaluation of organ preservation 

devices, with careful considerations of 

regulatory least burdensome principles, 

as well as, ethical principles in animal 

testing. This draft guidance provides 

clarity on premarket recommendations 

to develop animal transplant models for 

organ preservation technologies, which 

will streamline initiation of clinical 

studies. Optimizing animal and clinical 

study designs for premarket 

submissions will allow us to bring novel 

organ preservation devices to the market 

faster to increase the availability of 

organs for transplant for patients 

awaiting transplants. Early stakeholder 

feedback was sought to inform the 

development of this draft guidance 

through CDRH’s notice on the fiscal year 

2016 proposed guidance development 

issued December 29, 2015 (80 FR 

81335), available at https://

www.federalregister.gov/documents/ 

2015/12/29/2015-32726/medical-deviceuser-fee-and-modernization-act-noticeto-public-of-web-site-location-of-fiscalyear#h-14. Specific questions were 

posed to solicit input into the context of 

the guidance and comments were 

collected through Docket No. FDA– 

2012–N–1021. 

This draft guidance is a leapfrog 

guidance; leapfrog guidances are 

intended to serve as a mechanism by 

which the Agency can share initial 

thoughts regarding the content of 

premarket submissions for emerging 

technologies and new clinical 

applications that are likely to be of 

public health importance very early in 

product development. This leapfrog 

draft guidance represents the Agency’s 

initial thinking, and our 

recommendations may change as more 

information becomes available. The 

Agency strongly encourages 

manufacturers to engage with CDRH 

through the Pre-Submission process to 

obtain more detailed feedback regarding 

their organ preservation device. For 

more information on Pre-Submissions, 

please see ‘‘Requests for Feedback on 

Medical Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ at 

(https://www.fda.gov/downloads/ 

MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM311176.pdf). 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Utilizing Animal Studies to 

Evaluate Organ Preservation Devices.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This guidance is not subject 

to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. This 

guidance document is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Utilizing Animal Studies to Evaluate 

Organ Preservation Devices’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1500083 to identify 

the guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance document refers 

to previously approved collections of 

information found in FDA regulations 

and guidances. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 58 regarding good laboratory 

practices have been approved under 

OMB control number 0910–0119. The 

collections of information in 21 CFR 

part 801 regarding labeling have been 

approved under OMB control number 

0910–0485. The collections of 

information in 21 CFR part 807, subpart 

E regarding premarket notification have 

been approved under OMB control 

number 0910–0120. The collections of 

information in 21 CFR part 812 

regarding investigational device 

exemptions have been approved under 

OMB control number 0910–0078. The 

collections of information in 21 CFR 

part 814, subparts A through E regarding 

premarket approval have been approved 

under OMB control number 0910–0231. 

The collections of information in 21 

CFR part 814, subpart H have been 

approved under OMB control number 

0910–0332. The collections of 

information in 21 CFR part 820 

regarding the Quality System regulation 

have been approved under OMB control 

number 0910–0073. The collections of 

information in the guidance document 

entitled ‘‘Requests for Feedback on 

Medical Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ 

have been approved under OMB control 

number 0910–0756. 

Dated: September 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19613 Filed 9–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

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 

OIRA_submission@omb.eop.gov 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 

paperwork@hrsa.gov or call (301) 443– 

1984. 

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43392 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 

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 tollfree 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 tollfree 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

Instrument Number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Survey Respondents ........................................................ 2000 1 2000 .166 332 

Screened households ...................................................... 2600 1 2600 .016 41.6 

Total .......................................................................... 4600 ............................ 4600 ........................ 374 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: Government owned 

intellectual property covering imaging 

agents with improved renal clearance 

available for licensing and 

commercialization. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

patent applications listed below may be 

obtained by emailing the indicated 

licensing contact at the National Heart, 

Lung, and Blood, Office of Technology 

Transfer and Development Office of 

Technology Transfer, 31 Center Drive, 

Room 4A29, MSC2479, Bethesda, MD 

20892–2479; telephone: 301–402–5579. 

A signed Confidential Disclosure 

Agreement may be required to receive 

copies of the patent applications. 

SUPPLEMENTARY INFORMATION: The 

inventions listed below are owned by an 

agency of the U.S. Government and are 

available for licensing in the U.S. in 

accordance with 35 U.S.C. 209 and 37 

CFR part 404 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. A description of the 

technology available for licensing 

follows. 

Methods of Using Inhibitors To 

Enhance Therapeutic Uses of 

Endocannabinoids 

Description of Technology: The 

invention pertains to methods of using 

compounds that inhibit fatty acid amide 

hydrolase (FAAH) enzymes that are 

responsible for the degradation of 

oleamide and anandamide. Inhibition of 

degradation can be used as treatment 

modality for hypertension and for sleep 

disorders. The issued patent lists 

potentially useful compounds, one such 

useful compound in particular is 


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