Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 125 

revised reporting thresholds for certain 

data items. The Board also proposes to 

make changes to the reporting forms and 

instructions for the FR Y–9C, FR Y–9LP, 

and FR Y–9SP to implement accounting 

changes pertaining to equity securities 

under Accounting Standards update 

(ASU No. 2016–01, ‘‘Recognition and 

Measurement of Financial Assets and 

Financial Liabilities.’’). The accounting 

changes pertaining to equity securities 

would be effective beginning with the 

reports reflecting the March 31, 2018, 

report date and June 30, 2018 for all 

other changes. The proposed changes 

include: 

• Deleting and combining of certain 

data items pertaining to (1) Goodwill 

and Other intangible assets from 

Schedule HC, Balance Sheet; (2) U.S. 

Government agency obligations and 

structured financial products from 

Schedule HC–B, Securities; (3) 

Structured financial products and 

certain loans and the unpaid principal 

balance of such loans on Schedule HC– 

D, Trading Assets; (4) Certain over-the 

counter derivatives on Schedule HC–L, 

Derivatives and Off-Balance sheet items, 

and (5) Purchased credit card 

relationships and nonmortgage servicing 

assets from Schedule HC–M, 

Memoranda; 

• Deleting two preprinted captions 

for other noninterest income on 

Schedule HI, Income Statement and 

certain data items on Schedule HC–D, 

Trading Assets and Liabilities; 

• Deleting Column B (Domestic 

Office) from Schedule HC–D, Trading 

Assets and Liabilities 

• Reducing the reporting frequency 

from quarterly to semiannual and from 

quarterly to annual for certain data 

items on the FR Y–9C report 

• Increasing and adding reporting 

thresholds for certain data items in four 

FR Y–9C schedules 

• Revising the reporting forms and 

instructions to implement the reporting 

of equity securities under ASU–2016–01 

and 

• Moving ‘‘Goodwill’’ from Schedule 

HC to Schedule HC–M, Memoranda. 

Legal authorization and 

confidentiality: The Board’s Legal 

Division has determined that the FR Y– 

9 family of reports is authorized by 

section 5(c) of the Bank Holding 

Company Act (12 U.S.C. 1844(c)), 

section 10 of Home Owners’ Loan Act 

(12 U.S.C. 1467a(b) and 1850a(c)(1)), 

section 165 of the Dodd-Frank Act (12 

U.S.C. 5365), and section 252.153(b)(2) 

of Regulation YY (12 CFR 

252.153(b)(2)). The obligation of covered 

HCs to report this information is 

mandatory. In general, the Board does 

not consider the financial data in these 

reports to be confidential. However, a 

respondent may request confidential 

treatment pursuant to sections (b)(4), 

(b)(6), and (b)(8) of the Freedom of 

Information Act (5 U.S.C. 552(b)(4), 

(b)(6), and (b)(8)). The applicability of 

these exemptions would need to be 

reviewed on a case by case basis. 

Board of Governors of the Federal Reserve 

System, December 27, 2017. 

Ann E. Misback, 

Secretary of the Board. 

[FR Doc. 2017–28290 Filed 12–29–17; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0809] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), authorizes FDA to award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that LUXTURNA 

(voretigene neparvovec), manufactured 

by Spark Therapeutics, Inc., meets the 

criteria for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Gretchen Opper, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), which was 

added by FDASIA, FDA will award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria 

upon approval of those applications. 

FDA has determined that LUXTURNA 

(voretigene neparvovec), manufactured 

by Spark Therapeutics, Inc., meets the 

criteria for a priority review voucher. 

LUXTURNA (voretigene neparvovec) is 

an adeno-associated virus vector-based 

gene therapy indicated for the treatment 

of patients with confirmed biallelic 

RPE65 mutation-associated retinal 

dystrophy. Patients must have viable 

retinal cells as determined by the 

treating physician(s). 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRare

DiseasesConditions/RarePediatric

DiseasePriorityVoucherProgram/ 

default.htm. For further information 

about LUXTURNA (voretigene 

neparvovec), go to the Center for 

Biologics Evaluation and Research 

cellular and gene therapy products 

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

BiologicsBloodVaccines/Cellular

GeneTherapyProducts/Approved

Products/default.htm. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28256 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6928] 

Pediatric Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Pediatric Advisory 

Committee (PAC). The general function 

of the committee is to provide advice 

and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comments. 

DATES: The meeting will be held on 

March 23, 2018, from 8:30 a.m. to 3:05 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993– 

0002. Answers to commonly asked 

questions including information 

regarding special accommodations due 


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