Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35277 

informed decisions about the 

deployment of its resource center assets. 

These data are necessary for ACL to 

evaluate contractual compliance with 

established performance indicators. 

These metrics include quantifiable 

increases in uptake by stakeholders of 

training, case consultation and technical 

assistance, and measures of satisfaction 

with and perceived benefit from these 

services. For example, the metrics 

measure successful problem resolution 

as a result of the services provided and 

quantifiable data on fulfillment of 

requests for training, technical 

assistance, and consultation related to 

the contractually designated legal and 

systems development topic areas. 

The information requested by ACL 

from legal and aging/disability 

professionals falls into the following 

areas: (1) Requests for training, case 

consultation, and technical assistance 

through an online, secure Uniform 

Resource Support Request Tool; (2) 

general requests for Legal Training 

(including the volume of Webinar 

registrations); (3) Case Consultation and 

Technical Assistance; and (4) 

information about satisfaction and use 

of the services and support received in 

order to enable ACL to measure 

performance outcomes. 

Comments in Response to the 60-Day 

Federal Register Notice 

As required by 5 CFR 1320.8(d), a 60- 

day notice was published in the Federal 

Register on December 5, 2017 (Volume 

82, Number 232, pp. 57458–57460). One 

email was received expressing support 

for the data collection as proposed. No 

modifications were made to the 

proposed data collection elements and 

associated data collection instruments. 

Estimated Annualized Burden Hours 

The total estimated burden is 460.78 

hours per year for individuals 

requesting and/or receiving resource 

support through NCLER. This figure is 

based on ACL field testing of 8 

providers working within aging/ 

disability/legal networks who measured 

the time required to fully submit 

information by answering the required 

questions using standardized forms: 

Respondent/data collection activity Number of 

respondents 

Minutes per 

response 

Annual burden 

hours 

Resource Support Requests .................................................................................................... 80 1 min 54 sec ..... 2.53 

Legal Training, Case Consultation, Technical Assistance Requests ....................................... 14,000 1 min 42 sec ..... 397 

Outcome Measurement ............................................................................................................ 3,500 1 min 3 sec ....... 61.25 

Total ................................................................................................................................... 17,580 4 min 39 sec ..... 460.78 

Dated: July 12, 2018. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2018–15906 Filed 7–24–18; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2544] 

Use of Liquids and/or Soft Foods as 

Vehicles for Drug Administration: 

General Considerations for Selection 

and In Vitro Methods for Product 

Quality Assessments; 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 ‘‘Use of 

Liquids and/or Soft Foods as Vehicles 

for Drug Administration: General 

Considerations for Selection and In 

Vitro Methods for Product Quality 

Assessments.’’ This draft guidance 

applies to orally administered drug 

products and provides 

recommendations to sponsors who will 

use or recommend use of liquids and/ 

or soft foods as vehicles for drug 

administration in investigational new 

drug applications (INDs), new drug 

applications (NDAs), Biologics License 

Applications (BLAs), as applicable, and 

in supplements to these applications. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 24, 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–N–2544 for ‘‘Use of Liquids and/ 

or Soft Foods as Vehicles for Drug 

Administration: General Considerations 

for Selection and In Vitro Methods for 

Product Quality Assessments.’’ 

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. 


daltland on DSKBBV9HB2PROD with NOTICES
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