35278 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 

• 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copies of the draft guidance to the 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. Send one self-addressed 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access to the draft guidance document.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: 

Mamta Gautam-Basak, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 21, Rm. 2508, 

Silver Spring, MD 20993, 301–796– 

0712. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Use of Liquids and/or Soft Foods as 

Vehicles for Drug Administration: 

General Considerations for Selection 

and In Vitro Methods for Product 

Quality Assessments.’’ In the absence of 

availability of a dosage form that is 

appropriate for the targeted patient 

population (e.g., pediatric, geriatric), 

small amounts of liquids and/or soft 

foods can be used as described in the 

FDA-approved product labeling for 

immediate ingestion as the suitable 

vehicle(s) for oral administration of the 

specific drug product. 

Generally, drug products mixed in 

small amounts of liquids (5 to 15 

milliliters) or soft foods are used in 

pediatric and other patient populations 

who are unable to swallow solid oral 

dosage forms. Liquids and/or soft foods 

that are shown not to alter performance 

of the drug product, and are deemed 

compatible and suitable for use in the 

targeted patient populations, are 

considered suitable for use as vehicles 

with the specific drug product. 

This draft guidance addresses the 

approaches recommended for suitability 

determination of vehicles intended for 

use with specific drug products by 

providing the following: 

• Considerations for selection of 

liquids and/or soft foods as vehicles. 

• Standardized in vitro methodology 

and data recommendations for drug 

product quality assessments to qualify 

vehicle(s) for drug product 

administration. 

• Recommendations to communicate 

acceptable (qualified) vehicles in drug 

product labeling. If certain foods are 

found unacceptable, they should also be 

included in the labeling. 

This draft guidance and the methods 

it describes do not replace existing 

guidance documents that address foodeffect assessments on the drug product 

or dosage form, or stability testing 

conducted to support a shelf-life 

determination. For those drug products 

marketed with a vehicle for 

administration (i.e., the vehicle is 

copackaged with the drug product), the 

recommendations regarding selection 

and methods provided in this draft 

guidance are applicable, but additional 

considerations and recommendations 

may also apply. 

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 ‘‘Use of Liquids and/or Soft Foods as 

Vehicles for Drug Administration: 

General Considerations for Selection 

and In Vitro Methods for Product 

Quality Assessments.’’ 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 draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 312 (INDs) have been approved 

under 0910–0014, the collections of 

information in 21 CFR part 314 (NDAs 

and ANDAs) have been approved under 

0910–0001, and the collections of 

information in 21 CFR 201.56 and 

201.57 (Prescription Drug Product 

Labeling) have been approved under 

0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: July 19, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15870 Filed 7–24–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Scholarly and Journalistic Activities 

Deemed Not To Be Research: 2018 

Requirements; Draft Guidance; When 

Continuing Review Is Not Required 

During the 6-Month Delay Period of 

July 19, 2018 Through January 20, 

2019: 2018 Requirements; Draft 

Guidance Elimination of Institutional 

Review Board (IRB) Review of 

Research Applications and Proposals: 

2018 Requirements; Draft Guidance 

AGENCY: The Office for Human Research 

Protections, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, HHS. 

ACTION: Notice of availability. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35279 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

the Assistant Secretary for Health is 

announcing the availability of three 

draft guidance documents titled, 

‘‘Scholarly and Journalistic Activities 

Deemed Not to be Research: 2018 

Requirements,’’ ‘‘When Continuing 

Review Is Not Required During the 6- 

Month Delay Period of July 19, 2018 

through January 20, 2019: 2018 

Requirements,’’ and ‘‘Elimination of 

Institutional Review Board (IRB) Review 

of Research Applications and Proposals: 

2018 Requirements,’’ respectively. 

DATES: Submit written comments by 

August 24, 2018. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

documents titled ‘‘Scholarly and 

Journalistic Activities Deemed Not to be 

Research: 2018 Requirements,’’ ‘‘When 

Continuing Review Is Not Required 

During the 6-Month Delay Period of July 

19, 2018 through January 20, 2019: 2018 

Requirements,’’ and ‘‘Elimination of 

Institutional Review Board (IRB) Review 

of Research Applications and Proposals: 

2018 Requirements,’’ respectively, to the 

Division of Policy and Assurances, 

Office for Human Research Protections, 

1101 Wootton Parkway, Suite 200, 

Rockville, MD 20852. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–453–6909. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

draft guidance documents. 

You may submit comments identified 

by docket ID number HHS–OS–OPHS– 

2018–0012 (Scholarly and Journalistic 

Activities Deemed Not to be Research: 

2018 Requirements), docket ID number 

HHS–OS–OPHS–2018–0013 (When 

Continuing Review Is Not Required 

During the 6-Month Delay Period of July 

19, 2018 through January 20, 2019: 2018 

Requirements), and docket ID number 

HHS–OS–OPHS–2018–0014 

(Elimination of Institutional Review 

Board (IRB) Review of Research 

Applications and Proposals: 2018 

Requirements), respectively, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Enter the docket 

ID number and click on ‘‘Search.’’ On 

the next page, click the ‘‘Comment 

Now’’ action and follow the 

instructions. 

• Mail/Hand Delivery/Courier [For 

Paper, Disk, or CD–ROM Submissions]: 

Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852. 

Comments received, including any 

personal information, will be posted 

without change to http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852, 240–453–6900; email 

Irene.Stith-Coleman@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Overview 

OHRP, Office of the Assistant 

Secretary for Health, is announcing the 

availability of three draft guidance 

documents entitled ‘‘Scholarly and 

Journalistic Activities Deemed Not to be 

Research: 2018 Requirements,’’ ‘‘When 

Continuing Review Is Not Required 

During the 6-Month Delay Period of July 

19, 2018 through January 20, 2019: 2018 

Requirements,’’ and ‘‘Elimination of 

Institutional Review Board (IRB) Review 

of Research Applications and Proposals: 

2018 Requirements.’’ The draft guidance 

documents, when finalized, will 

represent OHRP’s current thinking on 

these topics. OHRP obtained input from 

HHS agencies and the Common Rule 

departments and agencies in developing 

the draft guidance documents. 

The ‘‘Scholarly and Journalistic 

Activities Deemed Not to be Research: 

2018 Requirements’’ draft guidance 

explains how certain scholarly and 

journalistic activities that focus directly 

on the specific individuals about whom 

the information is collected are deemed 

not to be research under the 2018 

Requirements of the regulations for the 

protection of human subjects (45 CFR 

part 46), and consequently do not have 

to satisfy the requirements of those 

regulations. It is intended for IRB 

administrators, IRB chairpersons, 

relevant institutional officials, and 

investigators who may be concerned 

about whether scholarly or journalistic 

activities need to satisfy the 2018 

Requirements of the regulations. 

The ‘‘When Continuing Review Is Not 

Required During the 6-Month Delay 

Period of July 19, 2018 through January 

20, 2019: 2018 Requirements’’ draft 

guidance provides information on the 

HHS regulations for the protection of 

human research subjects at 45 CFR part 

46 related to the circumstances in which 

continuing review of research is not 

required. In particular, this guidance 

applies to research that transitions to 

comply with the 2018 Requirements 

during the 6-month delay period from 

July 19, 2018 through January 20, 2019. 

This guidance only applies during the 6- 

month delay period. It is intended for 

Institutional Review Boards (IRBs), 

investigators, HHS funding agencies, 

and others that may be responsible for 

the review, conduct, or oversight of 

human subjects research conducted or 

supported by HHS. 

The ‘‘Elimination of Institutional 

Review Board (IRB) Review of Research 

Applications and Proposals: 2018 

Requirements’’ draft guidance provides 

guidance on the elimination of the 

requirement in the pre-2018 

Requirements (45 CFR 46.103(f)) that 

each application or proposal for 

research undergo IRB review and 

approval as part of the certification 

process. It is intended for Institutions, 

IRBs, investigators, HHS funding 

agencies, and others that may be 

responsible for the review, conduct, or 

oversight of nonexempt research 

involving human subjects conducted or 

supported by HHS. 

II. Electronic Access 

Persons with access may obtain the 

draft guidance documents on OHRP’s 

website at https://www.hhs.gov/ohrp/ 

regulations-and-policy/requests-forcomments/index.html. 

Dated: July 19, 2018. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2018–15908 Filed 7–24–18; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

jointly owned by an agency of the U.S. 

Government with Vanderbilt University, 

University of Alabama and University of 

Pennsylvania and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

U.S. patent application listed below 

may be obtained by communicating 

with Sury Vepa, Ph.D., J.D., Senior 

Licensing and Patenting Manager, 


daltland on DSKBBV9HB2PROD with NOTICES