31760 Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices 

1See 21 CFR 201.57(c)(2). 

‘‘Indications and Usage Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ This guidance provides 

recommendations on the general 

principles to consider when drafting an 

indication and how to write, organize, 

and format the information in the 

Indications and Usage section of the 

labeling. The draft guidance provides 

recommendations on what information 

to include in the indication and when 

limitations of use should be considered 

for the Indications and Usage section. 

The Indications and Usage section 

must state that the drug is indicated for 

the treatment, prevention, mitigation, 

cure, or diagnosis of a recognized 

disease or condition, or of a 

manifestation of a recognized disease or 

condition, or for the relief of symptoms 

associated with a recognized disease or 

condition.1 The draft guidance describes 

how to clearly convey such information 

and addresses circumstances where 

other information in addition to the 

identification of the disease or condition 

may be warranted. 

The draft guidance describes 

circumstances in which an indication 

may be broader than the specific 

parameters of the clinical studies 

supporting approval, as well as those 

where a narrower indication may be 

appropriate, and explains that the 

Indications and Usage section needs to 

make clear the scope of the indication. 

The draft guidance also describes 

circumstances in which an indication in 

an age group broader than the 

population that was studied may be 

considered for an adult population. 

However, this approach is generally not 

appropriate across pediatric populations 

or between adult and pediatric 

populations because of the statutory 

requirements related to pediatric 

assessments and the unique clinical 

considerations for pediatric patients. 

For example, pediatric patients may 

metabolize drugs differently from adults 

(in an age-related manner), are 

susceptible to different safety risks, and 

often require different dosing regimens, 

even after correction for weight. For 

these reasons, FDA recommends that 

age groups should be included in 

indications. An indication should state 

that a drug is approved, for example, ‘‘in 

adults,’’ ‘‘in pediatric patients X years of 

age and older,’’ or ‘‘in adults and 

pediatric patients X years of age and 

older.’’ FDA is interested in obtaining 

information and public comment on this 

recommendation and the implications 

of routinely including age groups in 

indications. 

This guidance is one in a series of 

guidances FDA is developing or has 

developed to assist applicants with the 

content and format of labeling for 

human prescription drug and biological 

products. In the Federal Register of 

January 24, 2006 (71 FR 3922), FDA 

published a final rule on labeling for 

human prescription drug and biological 

products. The final rule and additional 

guidances on labeling can be accessed at 

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

ComplianceRegulatoryInformation/Laws

ActsandRules/ucm084159.htm. The 

labeling requirements and these 

guidances are intended to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use. 

This 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 the content and format of the 

Indications and Usage section of 

labeling for human prescription drug 

and biological products. 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. The Paperwork Reduction Act of 

1995 

This draft 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 201.56 and 

201.57 have been approved under OMB 

control number 0910–0572; the 

collections of information in 21 CFR 

312.41 have been approved under OMB 

control number 0910–0014; the 

collections of information in 21 CFR 

314.126(c) and 314.70 have been 

approved under OMB control number 

0910–0001; and the collections of 

information in 21 CFR 601.12 have been 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: June 29, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14535 Filed 7–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–0545] 

Revised Recommendations for 

Reducing the Risk of Zika Virus 

Transmission by Blood and Blood 

Components; 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 final 

guidance for industry entitled ‘‘Revised 

Recommendations for Reducing the Risk 

of Zika Virus Transmission by Blood 

and Blood Components; Guidance for 

Industry.’’ The guidance document 

provides blood establishments that 

collect Whole Blood and blood 

components with revised 

recommendations to reduce the risk of 

transmission of Zika virus (ZIKV) by 

blood and blood components. The 

guidance does not apply to the 

collection of Source Plasma. The 

guidance announced in this notice 

supersedes the document of the same 

title dated August 2016 (August 2016 

Guidance). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 9, 2018. 

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, 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices 31761 

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–0545 for ‘‘Revised 

Recommendations for Reducing the Risk 

of Zika Virus Transmission by Blood 

and Blood Components; Guidance for 

Industry.’’ 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 

‘‘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 guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, 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: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Revised 

Recommendations for Reducing the Risk 

of Zika Virus Transmission by Blood 

and Blood Components; Guidance for 

Industry.’’ The guidance provides blood 

establishments that collect Whole Blood 

and blood components with revised 

recommendations to reduce the risk of 

transmission of ZIKV by blood and 

blood components. The guidance does 

not apply to the collection of Source 

Plasma. This guidance supersedes the 

August 2016 Guidance. 

In the August 2016 Guidance, FDA 

recognized ZIKV as a relevant 

transfusion-transmitted infection under 

21 CFR 630.3(h) and recommended 

universal individual donation nucleic 

acid testing (ID NAT) for ZIKV or the 

use of an FDA-approved pathogen 

reduction device. Since 2016, the 

number of ZIKV disease cases in the 

U.S. States and territories has decreased 

considerably. In addition, FDA has 

licensed a nucleic acid screening test(s) 

for the detection of ZIKV in individual 

or pooled samples. Considering the 

changing epidemiology of ZIKV in the 

United States and the availability of 

licensed screening tests, FDA is revising 

the recommendations contained in the 

August 2016 Guidance. In this guidance 

FDA explains that, in order to comply 

with the testing requirements in 21 CFR 

610.40(a)(3), blood establishments must 

test all donations collected in the 

United States and its territories with a 

licensed nucleic acid test for ZIKV, 

using either ID NAT or minipool (MP) 

NAT. The guidance explains the basis 

for FDA’s determination that universal 

MP NAT screening, with certain 

conditions identified to trigger ID NAT 

when local mosquito-borne ZIKV 

transmission is presumed in a collection 

area, provides an adequate and 

appropriate safeguard against the 

current and future risk of ZIKV 

transmission through blood transfusion. 

Alternatively, blood establishments can 

use an FDA-approved pathogen 

reduction device. The revised 

recommendations are less burdensome 

for blood establishments because fewer 

tests will be performed when donations 

are tested by MP NAT compared to ID 

NAT. However, the recommendations 

are consistent with public health 

considering the changing course of the 

ZIKV epidemic in the United States and 

the sensitivity of the licensed test(s) to 

detect ZIKV in blood donation. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

FDA is issuing this guidance for 

immediate implementation in 

accordance with 21 CFR 10.115(g)(2) 

without initially seeking prior comment 

because the Agency has determined that 

prior public participation is not feasible 

or appropriate. Specifically, we are not 

seeking comments because the guidance 

presents a less burdensome policy for 

reducing the risk of transfusiontransmitted ZIKV that is consistent with 

public health. The guidance represents 

the current thinking of FDA on 

recommendations for reducing the risk 

of Zika virus transmission by blood and 

blood components. It does not establish 


sradovich on DSK3GMQ082PROD with NOTICES
31762 Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices 

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 

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 parts 601 and 640, and Form 

FDA 356h have been approved under 

OMB control number 0910–0338; and 

the collections of information in 21 CFR 

parts 606 and 630 have been approved 

under OMB control number 0910–0116. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: June 28, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14537 Filed 7–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Pregnancy in Women with Disabilities. 

Date: July 23, 2018. 

Time: 12:00 p.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Denise Wiesch, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3138, 

MSC 7770, Bethesda, MD 20892, (301) 437– 

3478, wieschd@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Networks 

and Behavior in Psychiatric Disorders. 

Date: July 25, 2018. 

Time: 2:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Julius Cinque, MS, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5186, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

1252, cinquej@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR17–158: 

Epigenomes and Connectomes in Psychiatric 

Disorders. 

Date: July 26, 2018. 

Time: 2:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Julius Cinque, MS, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5186, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

1252, cinquej@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: July 3, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–14647 Filed 7–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Environmental 

Determinants of Diabetes. 

Date: July 9, 2018. 

Time: 1:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Elena Sanovich, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7351, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, 301–594–8886, 

sanoviche@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Review of Planning 

Grant Application (U34). 

Date: July 12, 2018. 

Time: 6:00 p.m. to 7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Barbara A. Woynarowska, 

Ph.D., Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 754, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

402–7172, woynarowskab@niddk.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK U34 

Telephone Review. 

Date: July 13, 2018. 

Time: 3:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Xiaodu Guo, MD, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7023, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–4719, 

guox@extra.niddk.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 


sradovich on DSK3GMQ082PROD with NOTICES