Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39449 

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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Richard Lostritto, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 51, Rm. 4132, 

Silver Spring, MD 20993, 301–796– 

1697. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Dissolution Testing and Acceptance 

Criteria for Immediate-Release Solid 

Oral Dosage Form Drug Products 

Containing High Solubility Drug 

Substances.’’ This guidance finalizes the 

draft guidance for industry entitled 

‘‘Dissolution Testing and Specification 

Criteria for Immediate-Release Solid 

Oral Dosage Forms Containing 

Biopharmaceutics Classification System 

Class 1 and 3 Drugs’’ (August 2015) (FR 

80 46019), and the recommendations in 

this guidance clarify the 

recommendations in the guidance for 

industry entitled ‘‘Dissolution Testing of 

Immediate Release Solid Oral Dosage 

Forms’’ (August 1997) (FR 62 44974) for 

high solubility drug substances in IR 

drug products that meet the conditions 

described in section III of this guidance. 

For drug substances that do not meet the 

conditions in this guidance, sponsors/ 

applicants should follow the 

recommendations provided in the 

August 1997 guidance. 

The title of this guidance has been 

revised to better reflect its focus on the 

solubility of the drug substance in the 

drug product. Therefore, a direct 

reference to biopharmaceutics 

classification system class 1 and class 3 

is not necessary because permeability 

requirements are not within the focus of 

this guidance. 

Drug absorption from a solid dosage 

form after oral administration depends 

on the release of the drug substance 

from the drug product, the dissolution 

or solubilization of the drug under 

physiological conditions, and the 

permeation across the gastrointestinal 

membrane. NDAs and ANDAs 

submitted to FDA contain 

bioavailability (BA) or bioequivalence 

(BE) data and in vitro dissolution data 

that, together with chemistry, 

manufacturing, and controls data, 

characterize the quality and 

performance of the drug product. In 

vitro dissolution data are generally 

obtained from: (1) Batches used in 

pivotal clinical and/or BA/BE studies, 

(2) batches used as stability registration 

batches, and (3) batches used in other 

human studies conducted during 

product development. In general, 

knowledge about the solubility, 

permeability, dissolution, and 

pharmacokinetics of a drug product is 

considered when defining dissolution 

acceptance criteria for the drug approval 

process. 

Immediate-release solid oral dosage 

form drug products containing high 

solubility drug substances are 

considered to be relatively low risk 

regarding the impact of dissolution on 

in vivo performance, provided the in 

vitro performance meets or exceeds the 

recommendations discussed within this 

guidance. This guidance establishes 

standard dissolution methodology and 

acceptance criteria that are appropriate 

for highly soluble drug substances that 

are formulated in IR dosage form. The 

availability of these standards will 

facilitate the rapid development of 

dissolution methodology and related 

acceptance criteria with no requirement 

to show discriminatory ability of the 

dissolution method for these products 

during drug product development. In 

addition, these standards will facilitate 

FDA’s evaluation of the data submitted 

in the application. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Dissolution Testing 

and Acceptance Criteria for ImmediateRelease Solid Oral Dosage Form Drug 

Products Containing High Solubility 

Drug Substances.’’ 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 guidance refers to previously 

approved collections of information that 

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 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17025 Filed 8–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0180] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for the Collection of Quantitative Data 

on Tobacco Products and 

Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

10, 2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0810. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 


sradovich on DSK3GMQ082PROD with NOTICES
39450 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 

Generic Clearance for the Collection of 

Quantitative Data on Tobacco Products 

and Communications; OMB Control 

Number 0910–0810—Extension 

In order to conduct educational and 

public information programs relating to 

tobacco use as authorized by section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)), FDA’s Center for Tobacco 

Products will create and use a variety of 

media to inform and educate the public, 

tobacco retailers, and health 

professionals about the risks of tobacco 

use, how to quit using tobacco products, 

and FDA’s role in regulating tobacco. 

To ensure that these health 

communication messages have the 

highest potential to be received, 

understood, and accepted by those for 

whom they are intended, the Center for 

Tobacco Products will conduct research 

and studies relating to the control and 

prevention of disease. In conducting 

such research, FDA will employ 

formative pretests. Formative pretests 

are conducted on a small scale, and 

their focus is on developing and 

assessing the likely effectiveness of 

communications with specific target 

audiences. This type of research 

involves: (1) Assessing audience 

knowledge, attitudes, behaviors, and 

other characteristics for the purpose of 

determining the need for and 

developing health messages, 

communication strategies, and public 

information programs and (2) pretesting 

these health messages, strategies, and 

program components while they are in 

developmental form to assess audience 

comprehension, reactions, and 

perceptions. 

Formative pretesting is a staple of best 

practices in communications research. 

Obtaining voluntary feedback from 

intended audiences during the 

development of messages and materials 

is crucial for the success of every 

communication program. The purpose 

of obtaining information from formative 

pretesting is that it allows FDA to 

improve materials and strategies while 

revisions are still affordable and 

possible. Formative pretesting can also 

avoid potentially expensive and 

dangerous unintended outcomes caused 

by audiences’ interpreting messages in a 

way that was not intended by the 

drafters. By maximizing the 

effectiveness of messages and strategies 

for reaching targeted audiences, the 

frequency with which tobacco 

communication messages need to be 

modified should be greatly reduced. 

The voluntary information collected 

will serve the primary purpose of 

providing FDA information about the 

perceived effectiveness of messages, 

advertisements, and materials in 

reaching and successfully 

communicating with their intended 

audiences. Quantitative testing 

messages and other materials with a 

sample of the target audience will allow 

FDA to refine messages, advertisements, 

and materials, including questionnaires 

or images, directed at consumers while 

the materials are still in the 

developmental stage. 

In the Federal Register of February 

13, 2018 (83 FR 6190), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. One PRA-related comment 

was received. 

Comment: The comment recommends 

that FDA should research and develop 

communications about educating adults 

about the continuum of risk, and 

educating adults to not provide tobacco 

products to youth. 

Response: FDA appreciates the 

comment. The content and focus on 

studies submitted through this generic 

clearance will depend on Agency 

priorities and needs, and is not yet 

determined at this time. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Screener ............................................................................... 130,500 1 130,500 0.083 (5 

minutes) 

10,831 

Self-Administered Surveys ................................................... 27,000 1 27,000 0.33 (20 

minutes) 

8,910 

Total .............................................................................. ........................ ........................ ........................ ........................ 19,741 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The number of respondents to be 

included in each new survey will vary, 

depending on the nature of the material 

or message being tested and the target 

audience. The burden for this 

information collection extension is 

proposed to increase by 12,613 hours 

since the last OMB approval. The 

burden increase is due to an increase in 

the number of respondents and the 

categories of respondents. 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17044 Filed 8–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2495] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Voluntary Labeling 

Indicating Whether Foods Have or 

Have Not Been Derived From 

Genetically Engineered Plants 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection associated with the guidance 

to assist manufacturers who wish to 

voluntarily label their foods (human and 

animal) as being made with or without 

bioengineering, or the use of 

bioengineered ingredients, to ensure 

that labeling is truthful and not 

misleading. 


sradovich on DSK3GMQ082PROD with NOTICES