83 FR 39449 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 154 (August 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 154 (August 9, 2018)
| Page Range | 39449-39450 | |
| FR Document | 2018-17044 |
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)] [Notices] [Pages 39449-39450] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17044] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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. [[Page 39450]] 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 ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Screener........................ 130,500 1 130,500 0.083 (5 10,831 minutes) Self-Administered Surveys....... 27,000 1 27,000 0.33 (20 8,910 minutes) ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 19,741 ---------------------------------------------------------------------------------------------------------------- \1\ There 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
![Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39449
Evaluation and Research, Food and characterize the quality and https://www.fda.gov/Drugs/Guidance
Drug Administration, 10001 New performance of the drug product. In ComplianceRegulatoryInformation/
Hampshire Ave., Hillandale Building, vitro dissolution data are generally Guidances/default.htm or https://
4th Floor, Silver Spring, MD 20993– obtained from: (1) Batches used in www.regulations.gov.
0002. Send one self-addressed adhesive pivotal clinical and/or BA/BE studies, Dated: August 3, 2018.
label to assist that office in processing (2) batches used as stability registration
Leslie Kux,
your requests. See the SUPPLEMENTARY batches, and (3) batches used in other
Associate Commissioner for Policy.
INFORMATION section for electronic human studies conducted during
product development. In general, [FR Doc. 2018–17025 Filed 8–8–18; 8:45 am]
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: knowledge about the solubility, BILLING CODE 4164–01–P
Richard Lostritto, Center for Drug permeability, dissolution, and
Evaluation and Research, Food and pharmacokinetics of a drug product is
considered when defining dissolution DEPARTMENT OF HEALTH AND
Drug Administration, 10903 New HUMAN SERVICES
Hampshire Avenue, Bldg. 51, Rm. 4132, acceptance criteria for the drug approval
Silver Spring, MD 20993, 301–796– process.
Immediate-release solid oral dosage Food and Drug Administration
1697.
form drug products containing high
SUPPLEMENTARY INFORMATION: solubility drug substances are [Docket No. FDA–2018–N–0180]
I. Background considered to be relatively low risk
regarding the impact of dissolution on Agency Information Collection
FDA is announcing the availability of in vivo performance, provided the in Activities; Submission for Office of
a guidance for industry entitled vitro performance meets or exceeds the Management and Budget Review;
‘‘Dissolution Testing and Acceptance recommendations discussed within this Comment Request; Generic Clearance
Criteria for Immediate-Release Solid guidance. This guidance establishes for the Collection of Quantitative Data
Oral Dosage Form Drug Products standard dissolution methodology and on Tobacco Products and
Containing High Solubility Drug acceptance criteria that are appropriate Communications
Substances.’’ This guidance finalizes the for highly soluble drug substances that
draft guidance for industry entitled are formulated in IR dosage form. The AGENCY: Food and Drug Administration,
‘‘Dissolution Testing and Specification availability of these standards will HHS.
Criteria for Immediate-Release Solid facilitate the rapid development of ACTION: Notice.
Oral Dosage Forms Containing dissolution methodology and related
Biopharmaceutics Classification System acceptance criteria with no requirement SUMMARY: The Food and Drug
Class 1 and 3 Drugs’’ (August 2015) (FR to show discriminatory ability of the Administration (FDA) is announcing
80 46019), and the recommendations in dissolution method for these products that a proposed collection of
this guidance clarify the during drug product development. In information has been submitted to the
recommendations in the guidance for addition, these standards will facilitate Office of Management and Budget
industry entitled ‘‘Dissolution Testing of FDA’s evaluation of the data submitted (OMB) for review and clearance under
Immediate Release Solid Oral Dosage in the application. the Paperwork Reduction Act of 1995.
Forms’’ (August 1997) (FR 62 44974) for This guidance is being issued
high solubility drug substances in IR consistent with FDA’s good guidance DATES: Fax written comments on the
drug products that meet the conditions practices regulation (21 CFR 10.115). collection of information by September
described in section III of this guidance. The guidance represents the current 10, 2018.
For drug substances that do not meet the thinking of FDA on ‘‘Dissolution Testing ADDRESSES: To ensure that comments on
conditions in this guidance, sponsors/ and Acceptance Criteria for Immediate- the information collection are received,
applicants should follow the Release Solid Oral Dosage Form Drug OMB recommends that written
recommendations provided in the Products Containing High Solubility comments be faxed to the Office of
August 1997 guidance. Drug Substances.’’ It does not establish Information and Regulatory Affairs,
The title of this guidance has been any rights for any person and is not OMB, Attn: FDA Desk Officer, Fax: 202–
revised to better reflect its focus on the binding on FDA or the public. You can 395–7285, or emailed to oira_
solubility of the drug substance in the use an alternative approach if it satisfies submission@omb.eop.gov. All
drug product. Therefore, a direct the requirements of the applicable comments should be identified with the
reference to biopharmaceutics statutes and regulations. This guidance OMB control number 0910–0810. Also
classification system class 1 and class 3 is not subject to Executive Order 12866. include the FDA docket number found
is not necessary because permeability
II. Paperwork Reduction Act of 1995 in brackets in the heading of this
requirements are not within the focus of
document.
this guidance. This guidance refers to previously
Drug absorption from a solid dosage approved collections of information that FOR FURTHER INFORMATION CONTACT:
form after oral administration depends are subject to review by the Office of Amber Sanford, Office of Operations,
on the release of the drug substance Management and Budget (OMB) under Food and Drug Administration, Three
from the drug product, the dissolution the Paperwork Reduction Act of 1995 White Flint North, 10A–12M, 11601
or solubilization of the drug under (44 U.S.C. 3501–3520). The collections Landsdown St., North Bethesda, MD
physiological conditions, and the
sradovich on DSK3GMQ082PROD with NOTICES
of information in 21 CFR parts 312 and 20852, 301–796–8867, PRAStaff@
permeation across the gastrointestinal 314 have been approved under OMB fda.hhs.gov.
membrane. NDAs and ANDAs control numbers 0910–0014 and 0910–
submitted to FDA contain 0001, respectively. SUPPLEMENTARY INFORMATION: In
bioavailability (BA) or bioequivalence compliance with 44 U.S.C. 3507, FDA
(BE) data and in vitro dissolution data III. Electronic Access has submitted the following proposed
that, together with chemistry, Persons with access to the internet collection of information to OMB for
manufacturing, and controls data, may obtain the guidance at either review and clearance.
VerDate Sep<11>2014 18:11 Aug 08, 2018 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1](https://thefederalregister.org/doc/83_FR_39603/page/1.svg)
![39450 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
Generic Clearance for the Collection of other characteristics for the purpose of providing FDA information about the
Quantitative Data on Tobacco Products determining the need for and perceived effectiveness of messages,
and Communications; OMB Control developing health messages, advertisements, and materials in
Number 0910–0810—Extension communication strategies, and public reaching and successfully
information programs and (2) pretesting communicating with their intended
In order to conduct educational and these health messages, strategies, and audiences. Quantitative testing
public information programs relating to program components while they are in messages and other materials with a
tobacco use as authorized by section developmental form to assess audience sample of the target audience will allow
1003(d)(2)(D) of the Federal Food, Drug, comprehension, reactions, and FDA to refine messages, advertisements,
and Cosmetic Act (21 U.S.C. perceptions. and materials, including questionnaires
393(d)(2)(D)), FDA’s Center for Tobacco Formative pretesting is a staple of best or images, directed at consumers while
Products will create and use a variety of practices in communications research. the materials are still in the
media to inform and educate the public, Obtaining voluntary feedback from developmental stage.
tobacco retailers, and health intended audiences during the
professionals about the risks of tobacco In the Federal Register of February
development of messages and materials 13, 2018 (83 FR 6190), FDA published
use, how to quit using tobacco products, is crucial for the success of every
and FDA’s role in regulating tobacco. a 60-day notice requesting public
communication program. The purpose comment on the proposed collection of
To ensure that these health of obtaining information from formative information. One PRA-related comment
communication messages have the pretesting is that it allows FDA to was received.
highest potential to be received, improve materials and strategies while
understood, and accepted by those for revisions are still affordable and Comment: The comment recommends
whom they are intended, the Center for possible. Formative pretesting can also that FDA should research and develop
Tobacco Products will conduct research avoid potentially expensive and communications about educating adults
and studies relating to the control and dangerous unintended outcomes caused about the continuum of risk, and
prevention of disease. In conducting by audiences’ interpreting messages in a educating adults to not provide tobacco
such research, FDA will employ way that was not intended by the products to youth.
formative pretests. Formative pretests drafters. By maximizing the Response: FDA appreciates the
are conducted on a small scale, and effectiveness of messages and strategies comment. The content and focus on
their focus is on developing and for reaching targeted audiences, the studies submitted through this generic
assessing the likely effectiveness of frequency with which tobacco clearance will depend on Agency
communications with specific target communication messages need to be priorities and needs, and is not yet
audiences. This type of research modified should be greatly reduced. determined at this time.
involves: (1) Assessing audience The voluntary information collected FDA estimates the burden of this
knowledge, attitudes, behaviors, and will serve the primary purpose of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Screener ............................................................................... 130,500 1 130,500 0.083 (5 10,831
minutes)
Self-Administered Surveys ................................................... 27,000 1 27,000 0.33 (20 8,910
minutes)
Total .............................................................................. ........................ ........................ ........................ ........................ 19,741
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be DEPARTMENT OF HEALTH AND comment on the proposed collection of
included in each new survey will vary, HUMAN SERVICES certain information by the Agency.
depending on the nature of the material Under the Paperwork Reduction Act of
or message being tested and the target Food and Drug Administration 1995 (PRA), Federal Agencies are
audience. The burden for this required to publish notice in the
[Docket No. FDA–2018–N–2495] Federal Register concerning each
information collection extension is
proposed to increase by 12,613 hours proposed collection of information,
Agency Information Collection
since the last OMB approval. The including each proposed extension of an
Activities; Proposed Collection;
burden increase is due to an increase in existing collection of information, and
Comment Request; Voluntary Labeling
the number of respondents and the to allow 60 days for public comment in
Indicating Whether Foods Have or
response to the notice. This notice
categories of respondents. Have Not Been Derived From
solicits comments on the information
Dated: August 3, 2018. Genetically Engineered Plants
collection associated with the guidance
sradovich on DSK3GMQ082PROD with NOTICES
Leslie Kux, AGENCY: Food and Drug Administration, to assist manufacturers who wish to
Associate Commissioner for Policy. HHS. voluntarily label their foods (human and
[FR Doc. 2018–17044 Filed 8–8–18; 8:45 am] ACTION: Notice. animal) as being made with or without
bioengineering, or the use of
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug bioengineered ingredients, to ensure
Administration (FDA or Agency) is that labeling is truthful and not
announcing an opportunity for public misleading.
VerDate Sep<11>2014 18:11 Aug 08, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1](https://thefederalregister.org/doc/83_FR_39603/page/2.svg)
Document Created: 2018-08-09 01:10:43
Document Modified: 2018-08-09 01:10:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by September 10, 2018. | |
| 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, [email protected] | |
| FR Citation | 83 FR 39449 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR