39448 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 

3. Mason, M.J., D.L. Scammon, and X. Feng. 

‘‘The Impact of Warnings, Disclaimers 

and Product Experience on Consumers’ 

Perceptions of Dietary Supplements.’’ 

Journal of Consumer Affairs, 41(1), 74– 

99. (2007). 

4. France, K.R. and P.F. Bone. ‘‘Policy 

Makers’ Paradigms and Evidence from 

Consumer Interpretations of Dietary 

Supplement Labels.’’ Journal of 

Consumer Affairs, 39(1), 27–51. (2005). 

5. FTC. ‘‘Full Disclosure.’’ Accessed at: 

https://www.ftc.gov/news-events/blogs/ 

business-blog/2014/09/full-disclosure 

(September 23, 2014) Last accessed on 

June 22, 2018. 

6. Higgins, E., M. Leinenger, and K. Rayner. 

‘‘Eye Movements When Viewing 

Advertisements.’’ Frontiers in 

Psychology, 5, 210. (2014). 

7. Pieters, R., M. Wedel, and R. Batra. ‘‘The 

Stopping Power of Advertising: 

Measures and Effects of Visual 

Complexity.’’ Journal of Marketing, 

74(5), 48–60. (2010). 

8. Thomsen, S. and K. Fulton. ‘‘Adolescents’ 

Attention to Responsibility Messages in 

Magazine Alcohol Advertisements: An 

Eye-Tracking Approach.’’ Journal of 

Adolescent Health, 41, 27–34. (2007). 

9. Simola, J., J. Kuisma, A. O ̈ o ̈rni, L. Uusitalo, 

et al. ‘‘The Impact of Salient 

Advertisements on Reading and 

Attention on Web pages.’’ Journal of 

Experimental Psychology: Applied, 

17(2), 174–190. (2011). 

10. Wedel, M. and R. Pieters. ‘‘A Review of 

Eye-Tracking Research in Marketing.’’ In 

Review of Marketing Research, vol. 4 (pp. 

123–147), N. K. Malhotra (Ed.). Armonk, 

New York: M. E. Sharpe. (2008). 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17045 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–D–2614] 

Dissolution Testing and Acceptance 

Criteria for Immediate-Release Solid 

Oral Dosage Form Drug Products 

Containing High Solubility Drug 

Substances; 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 

‘‘Dissolution Testing and Acceptance 

Criteria for Immediate-Release Solid 

Oral Dosage Form Drug Products 

Containing High Solubility Drug 

Substances.’’ This guidance has been 

developed to provide manufacturers 

with recommendations for submission 

of new drug applications (NDAs), 

investigational new drug applications 

(INDs), or abbreviated new drug 

applications (ANDAs), as appropriate, 

for orally administered immediaterelease (IR) drug products that contain 

highly soluble drug substances. The 

guidance is intended to describe when 

a standard release test and criteria may 

be used in lieu of extensive method 

development and acceptance criteriasetting exercises. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 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, 

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–2614 for ‘‘Dissolution Testing 

and Acceptance Criteria for ImmediateRelease Solid Oral Dosage Form Drug 

Products Containing High Solubility 

Drug Substances.’’ 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 this guidance to the Division 

of Drug Information, Center for Drug 


sradovich on DSK3GMQ082PROD with NOTICES
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