43390 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

Agency will continue to list the drug 

products in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs and ANDAs listed are unaffected 

by the discontinued marketing of the 

products subject to those NDAs and 

ANDAs. Additional ANDAs that refer to 

these products may also be approved by 

the Agency if they comply with relevant 

legal and regulatory requirements. If 

FDA determines that labeling for these 

drug products should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: September 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19611 Filed 9–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–4886] 

Utilizing Animal Studies To Evaluate 

Organ Preservation Devices; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance 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. This draft guidance is not final 

nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 14, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–4886 for ‘‘Utilizing Animal 

Studies to Evaluate Organ Preservation 

Devices.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). An electronic copy of the 

guidance document is available for 

download from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Utilizing Animal 

Studies to Evaluate Organ Preservation 

Devices’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Kunkoski, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1504, Silver Spring, 

MD 20993–0002, 301–796–6439. 

SUPPLEMENTARY INFORMATION: 

mstockstill on DSK30JT082PROD with NOTICES

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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