40524 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17524 Filed 8–14–18; 8:45 am] 

BILLING CODE 4164–01–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 CRYSVITA 

(burosamab-twza), manufactured by 

Ultragenyx Pharmaceutical, Inc., 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 CRYSVITA 

(burosamab-twza), manufactured by 

Ultragenyx Pharmaceutical, Inc., meets 

the criteria for a priority review 

voucher. CRYSVITA (burosamab-twza) 

is indicated for the treatment of Xlinked hypophosphatemia in adult and 

pediatric patients 1 year of age and 

older. 

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 CRYSVITA 

(burosumab-twza), go to the ‘‘Drugs@

FDA’’ website at https://

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

daf/. 

Dated: August 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17527 Filed 8–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–0943] 

Elemental Impurities in Animal Drug 

Products—Questions and Answers; 

Draft Guidance for Industry; 

Availability; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; reopening 

of the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

reopening the comment period for the 

notice of availability that published in 

the Federal Register on March 27, 2018. 

In that document, FDA requested 

comments on the draft guidance for 

industry (GFI) #255 entitled ‘‘Elemental 

Impurities in Animal Drug Products— 

Questions and Answers.’’ The Agency is 

taking this action in response to 

requests for an extension to allow 

interested parties additional time to 

develop and submit comments. 

DATES: FDA is reopening the comment 

period on the notice of availability 

published March 27, 2018 (83 FR 

13134). Submit either electronic or 

written comments on the draft guidance 

by October 15, 2018 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– 

2018–D–0943 for ‘‘Elemental Impurities 

in Animal Drug Products—Questions 

and Answers.’’ 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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices 40525 

‘‘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)). Submit written requests 

for single copies of the draft guidance to 

the Policy and Regulations Staff (HFV– 

6), Center for Veterinary Medicine, Food 

and Drug Administration, 7500 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 draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Michael Brent, Center for Veterinary 

Medicine (HFV–140), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0647, 

michael.brent@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 27, 

2018, FDA published a notice of 

availability with a 60-day comment 

period to request comments on draft GFI 

#255 entitled ‘‘Elemental Impurities in 

Animal Drug Products—Questions and 

Answers.’’ 

This level 1 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 ‘‘Elemental 

Impurities in Animal Drug Products— 

Questions and Answers’’, providing 

recommendations to sponsors regarding 

the control of elemental impurities in 

animal drug products, including all 

dosage forms and routes of 

administration. 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. 

The Agency received two requests for 

an extension of the comment period for 

the draft guidance. The requestors 

indicated they needed more time to 

complete development of comments to 

submit in response to the draft 

guidance. 

FDA has considered the requests and 

is reopening the comment period for the 

draft guidance for 60 days, until October 

15, 2018. The Agency believes that a 60- 

day reopening of the comment period 

allows adequate time for interested 

persons to submit comments to ensure 

that the Agency can consider the 

comments on this draft guidance before 

it begins work on the final version of the 

guidance. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. 

Dated: August 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17525 Filed 8–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Division of Epidemiology and Disease 

Prevention Epidemiology Program for 

American Indian/Alaska Native Tribes 

and Urban Indian Communities 

Announcement Type: Competing 

Supplement 

Funding Announcement Number: HHS– 

2018–IHS–EPI–0002 

Catalog of Federal Domestic Assistance 

Number: 93.231 

Key Dates 

Application Deadline Date: September 

12, 2018 

Review Date: September 14–18, 2018 

Earliest Anticipated Start Date: 

September 30, 2018 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) 

Office of Public Health Support, 

Division of Epidemiology and Disease 

Prevention (DEDP), is accepting 

applications for a cooperative agreement 

for competitive supplemental funds to 

enhance activities in the Epidemiology 

Program for American Indian/Alaska 

Native (AI/AN) Tribes and Urban Indian 

communities. 

This program is authorized under: 

Section 317(k)(2) of the Public Health 

Service Act [42 U.S.C. 247(b)(k)(2), as 

amended]. Funding for this award will 

be provided by: The Centers for Disease 

Control and Prevention’s (CDC) National 

Center for Emerging and Zoonotic 

Infectious Diseases (NCEZID). The 

authorities will be exercised by CDC 

and through an Intra-Departmental 

Delegation of Authority (IDDA) with 

IHS to create a supplemental funding 

opportunity for Tribal Epidemiology 

Centers. The administration will be 

carried out through an Intra-agency 

Agreement (IAA) between CDC and IHS. 

This program is described in the Catalog 

of Federal Domestic Assistance (CFDA) 

under 93.231. 

Background 

The Tribal Epidemiology Center (TEC) 

program was authorized by Congress in 

1998 as a way to provide public health 

support to multiple Tribes and Urban 

Indian communities in each of the IHS 

Areas. Only current TEC grantees 

serving Arizona Indian Tribes or Urban 

Indian communities with confirmed 

cases of Rocky Mountain spotted fever 

(RMSF) between 2003–2017 are eligible 

to apply for the competing 

supplemental funding under this 

announcement and must demonstrate 

that they have complied with previous 

terms and conditions of the TEC 

program. 

Positioned uniquely within Tribes 

and Tribal or Urban Organizations, 

TECs are able to conduct disease 

surveillance, research, prevention and 

control of disease, injury, or disability. 

This allows them to assess the 

effectiveness of AI/AN public health 

programs. In addition, they can fill gaps 

in data needed for the relevant 

Government Performance and Results 

Act and Healthy People 2020 measures. 

Some of the existing TECs have already 


daltland on DSKBBV9HB2PROD with NOTICES