Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices 64133 

FOR FURTHER INFORMATION CONTACT: 

Karen Takahashi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 75, Rm. 6686, 

Silver Spring, MD 20993–0002, 301– 

796–3191; Stephen Ripley, 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; or Jonathan Bray, Center 

for Veterinary Medicine (HFV–232), 

Food and Drug Administration, 7519 

Standish Pl., Rm. 130, Rockville, MD 

20855, 240–402–5623. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Data 

Integrity and Compliance With Drug 

CGMP: Questions and Answers.’’ In 

recent years, FDA has increasingly 

observed CGMP violations involving 

data integrity during CGMP inspections. 

This is troubling because ensuring data 

integrity is an important component of 

industry’s responsibility to ensure the 

safety, efficacy, and quality of drugs, 

and of FDA’s ability to protect the 

public health. These data integrityrelated CGMP violations have led to 

numerous regulatory actions, including 

warning letters, import alerts, and 

consent decrees. The underlying 

premise in 21 CFR 210.1 and 212.2 is 

that CGMP sets forth minimum 

requirements to assure that drugs meet 

the standards of the Federal Food, Drug, 

and Cosmetic Act regarding safety, 

identity, strength, quality, and purity. 

The guidance addresses specific 

questions about how data integrity 

relates to compliance with CGMP for 

drugs, as well as more general data 

integrity concepts, in question and 

answer format. This guidance was 

published as a draft guidance in April 

2016—‘‘Data Integrity and Compliance 

With CGMP’’—and has been revised in 

response to comments from the docket 

for clarity. Other comments to the 

docket requested additional details on 

FDA’s thinking on current best practices 

and additional examples. The Agency 

has used clarifying language and 

additional examples that also address 

best practices for ensuring data 

integrity. A paragraph regarding 

independent security role assignments 

for small operations or facilities was 

removed because the guidance for 

industry ‘‘PET Drugs—Current Good 

Manufacturing Practice (CGMP)’’ 

covering this topic is sufficiently clear. 

This 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 data integrity and 

compliance with drug CGMP. 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. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information that 

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 parts 210 and 

211 (CGMPs), 212 (positron emission 

tomography CGMPs), and 11 (electronic 

records and signatures) have been 

approved under OMB control numbers 

0910–0139, 0910–0667, and 0910–0303, 

respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, https://

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, or 

https://www.regulations.gov. 

Dated: December 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–26957 Filed 12–12–18; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4609] 

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 GAMIFANT 

(emapalumab-lzsg) Injection, 

manufactured by Novimmune S.A., 

meets the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Althea Cuff, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4061, Fax: 301–796–9856, 

email: althea.cuff@fda.hhs.gov. 

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. 

FDA has determined that GAMIFANT 

(emapalumab-lzsg) Injection, 

manufactured by Novimmune S.A., 

meets the criteria for a priority review 

voucher. GAMIFANT (emapalumablzsg) Injection is indicated for the 

treatment of adult and pediatric 

(newborn and older) patients with 

primary hemophagocytic 

lymphohistiocytosis (HLH) with 

refractory, recurrent or progressive 

disease or intolerance with conventional 

HLH therapy. 

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/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about GAMIFANT 

(emapalumab-lzsg) Injection, go to the 

‘‘Drugs@FDA’’ website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: December 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27043 Filed 12–12–18; 8:45 am] 

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