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this notice finalizes the draft guidance 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] 

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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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