Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices 31759 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. American Heartland Bancshares, 

Inc., Sugar Grove, Illinois; to acquire 

100 percent of the voting shares of 

Community Holdings Corporation and 

thereby indirectly acquire First Secure 

Bank and Trust Company, both of Palos 

Hills, Illinois. 

Board of Governors of the Federal Reserve 

System, July 3, 2018. 

Yao-Chin Chao, 

Assistant Secretary of the Board. 

[FR Doc. 2018–14641 Filed 7–6–18; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1895] 

Indications and Usage Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format; Draft Guidance for Industry; 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 draft 

guidance for industry entitled 

‘‘Indications and Usage Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ This guidance is intended to 

assist applicants in writing the 

Indications and Usage section of 

labeling. The recommendations in this 

draft guidance are intended to help 

ensure that the labeling is clear, concise, 

useful, and informative and, to the 

extent possible, consistent in content 

and format within and across drug and 

therapeutic classes. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 7, 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draft guidance before it begins work on 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–1895 for ‘‘Indications and 

Usage Section of Labeling for Human 

Prescription Drug and Biological 

Products—Content and Format; Draft 

Guidance for Industry; Availability.’’ 

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 draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

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. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Iris 

Masucci, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Silver Spring, MD 

20993–0002, 301–796–2500; or 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 


sradovich on DSK3GMQ082PROD with NOTICES
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