40008 Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2013–E–0264; FDA– 

2013–E–0263; and FDA–2013–E–0218] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RECUVYRA; Affirmation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of affirmation. 

DATES: August 23, 2017 

FOR FURTHER INFORMATION CONTACT: 

Joyce Strong, Office of Policy, 10903 

New Hampshire Ave., Bldg. 51, Silver 

Spring, MD 20993, 301–796–9148. 

SUPPLEMENTARY INFORMATION: The Food 

and Drug Administration (FDA) is 

affirming the signature date for a notice 

that appeared in the Federal Register on 

August 21, 2017 (82 FR 39587). The 

document announced FDA’s 

determination for the regulatory review 

period for RECUVYRA. The document 

published with an incorrect date for the 

signature. We affirm that the document 

was signed on August 15, 2017. 

Dated: August 21, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17961 Filed 8–21–17; 4:15 pm] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1248] 

Oncology Drugs for Companion 

Animals; Guidance for Industry; 

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 a 

guidance for industry #237 entitled 

‘‘Oncology Drugs for Companion 

Animals.’’ The guidance provides 

recommendations for sponsors of 

investigational oncology drugs for use in 

companion animals (e.g., dogs, cats, and 

horses), discusses the contents of a new 

animal drug application for certain 

oncology drugs, and provides 

recommendations on how to address 

human user safety concerns. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 23, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2016–D–1248 for ‘‘Oncology Drugs for 

Companion Animals.’’ 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 

office 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. 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Loss, Center for Veterinary 

Medicine (HFV–116), Food and Drug 

Administration, 7500 Standish Pl., Rm. 

N310, Rockville, MD 20855, 240–402– 

0619, christopher.loss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 10, 

2016 (81 FR 37605), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Oncology Drugs for 

Companion Animals’’ giving interested 

persons until August 9, 2016, to 

comment on the draft guidance. FDA 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40009 

received no comments on the draft 

guidance. The guidance announced in 

this notice finalizes the draft guidance 

dated June 2015. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on oncology drugs for 

companion animals. 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. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. 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 514.1 and 514.8 have been 

approved under OMB control number 

0910–0032. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. 

Dated: August 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17855 Filed 8–22–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2013–N–0804; FDA– 

2013–N–1163; FDA–2013–N–1393; FDA– 

2017–N–0084; FDA–2013–N–0731; FDA– 

2009–D–0008; FDA–2013–N–0868; FDA– 

2013–D–0117; FDA–2016–N–2066; FDA– 

2017–N–0366] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, FDA PRA Staff, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 11601 Landsdown St., North 

Bethesda, MD 20852, 301–796–7726, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Premarket Notification Submission 510(k), Subpart E ............................................................................................ 0910–0120 6/30/2020 

Institutional Review Boards ..................................................................................................................................... 0910–0130 6/30/2020 

Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions ................................ 0910–0233 6/30/2020 

Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)) ................................. 0910–0471 6/30/2020 

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products ............. 0910–0543 6/30/2020 

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and 

Cosmetic Act ........................................................................................................................................................ 0910–0679 6/30/2020 

Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion ......................................................... 0910–0681 6/30/2020 

Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, 

Drug, and Cosmetic Act ....................................................................................................................................... 0910–0762 6/30/2020 

Certification of Identity for Freedom of Information Act and Privacy Act Requests ............................................... 0910–0832 6/30/2020 

FDA Advisory Committee Membership Nominations .............................................................................................. 0910–0833 6/30/2020 

Dated: August 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17871 Filed 8–22–17; 8:45 am] 

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