83 FR 44888 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 171 (September 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 171 (September 4, 2018)
| Page Range | 44888-44890 | |
| FR Document | 2018-19088 |
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)] [Notices] [Pages 44888-44890] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19088] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3037] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the creation of a new collection of information entitled ``Generic Clearance for Quantitative Testing for the Development of FDA Communications.'' DATES: Submit either electronic or written comments on the collection of information by November 5, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 5, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the [[Page 44889]] 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-3037 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications.'' Received comments, those filed in a timely manner (see ADDRESSES), 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.thefederalregister.org/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. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Generic Clearance for Quantitative Testing for the Development of FDA Communications OMB Control Number 0910--New This notice announces the FDA information collection request from OMB for a generic clearance that will allow FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers' reactions to FDA communications or educational messaging about FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed. To ensure that communications activities and educational campaigns have the highest potential to be received, understood, and accepted by those for whom they are intended, it is important to assess communications while they are under development. Understanding consumers' attitudes, motivations, and behaviors in response to potential communications and education messaging plays an important role in improving FDA's communications. If the following conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process: The collections are voluntary; The collections are low burden for participants (based on considerations of total burden hours, total number of participants, or burden hours per participant) and are low cost for both the participants and the Federal Government; The collections are noncontroversial; Personally identifiable information (PII) is collected only to the extent necessary \1\ and is not retained; --------------------------------------------------------------------------- \1\ For example, collections that collect PII to provide remuneration for participants of focus groups and cognitive laboratory studies will be submitted under this request. All Privacy Act requirements will be met. --------------------------------------------------------------------------- [[Page 44890]] Information gathered will not be used for the purpose of substantially informing influential policy decisions; \2\ and --------------------------------------------------------------------------- \2\ As defined in OMB and agency Information Quality Guidelines, ``influential'' means that ``an agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important public policies or important private sector decisions.'' --------------------------------------------------------------------------- Information gathered will yield qualitative findings; the collections will not be designed or expected to yield statistical data or used as though the results are generalizable to the population of study. To obtain approval for a collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB along with supporting documentation (e.g., a copy of the survey or experimental design and stimuli for testing). FDA will submit individual quantitative collections under this generic clearance to OMB. Individual quantitative collections will also undergo review by FDA's Research Involving Human Subjects Committee, senior leadership in the Center for Food Safety and Applied Nutrition, and PRA specialists. Respondents to this collection of information may include a wide range of consumers and other FDA stakeholders such as producers and manufacturers who are regulated under FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden by Anticipated Data Collection Methods \1\ ---------------------------------------------------------------------------------------------------------------- Number of Survey type Number of responses per Total annual Total hours respondents respondent responses ---------------------------------------------------------------------------------------------------------------- Cognitive Interviews Screener................... 720 1 720 60 Cognitive Interviews............................ 144 1 144 144 Pre-test Study Screener......................... 2,400 1 2,400 199 Pre-testing Study............................... 480 1 480 120 Self-administered Surveys/Experimental Studies 75,000 1 75,000 6,225 Screener....................................... Self-Administered Surveys/Experimental Studies.. 15,000 1 15,000 3,750 --------------------------------------------------------------- Total....................................... .............. .............. .............. 10,498 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The total estimated annual burden is 10,498 hours. Current estimates are based on both historical numbers of participants from past projects as well as estimates for projects to be conducted in the next 3 years. The number of participants to be included in each new survey will vary, depending on the nature of the compliance efforts and the target audience. Dated: August 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19088 Filed 8-31-18; 8:45 am] BILLING CODE 4164-01-P
![44888 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
one non-voting member who is Silver Spring, MD 20993–0002, 301– U.S.C. app.). For general information
identified with industry interests. 796–9001, email: EMDAC@fda.hhs.gov. related to FDA advisory committees,
Further information regarding the SUPPLEMENTARY INFORMATION: Pursuant please check https://www.fda.gov/
most recent charter and other to 41 CFR 102–3.65 and approval by the AdvisoryCommittees/default.htm.
information can be found at https:// Department of Health and Human Dated: August 28, 2018.
www.fda.gov/AdvisoryCommittees/ Services pursuant to 45 CFR part 11 and Leslie Kux,
CommitteesMeetingMaterials/;Drugs/ by the General Services Administration, Associate Commissioner for Policy.
CardiovascularandRenalDrugsAdvisory FDA is announcing the renewal of the
Committee/ucm094743.htm or by [FR Doc. 2018–19066 Filed 8–31–18; 8:45 am]
Endocrinologic and Metabolic Drugs
contacting the Designated Federal BILLING CODE 4164–01–P
Advisory Committee (the Committee).
Officer (see FOR FURTHER INFORMATION The Committee is a discretionary
CONTACT). In light of the fact that no Federal advisory committee established
change has been made to the committee DEPARTMENT OF HEALTH AND
to provide advice to the Commissioner.
name or description of duties, no The Committee advises the HUMAN SERVICES
amendment will be made to 21 CFR Commissioner or designee in Food and Drug Administration
14.100. discharging responsibilities as they
This document is issued under the relate to helping to ensure safe and [Docket No. FDA–2018–N–3037]
Federal Advisory Committee Act (5 effective drugs for human use and, as
U.S.C. app.). For general information required, any other product for which Agency Information Collection
related to FDA advisory committees, the Food and Drug Administration has Activities; Proposed Collection;
please check https://www.fda.gov/ regulatory responsibility. Comment Request; Generic Clearance
AdvisoryCommittees/default.htm. The Committee reviews and evaluates for Quantitative Testing for the
data concerning the safety and Development of FDA Communications
Dated: August 28, 2018.
effectiveness of marketed and AGENCY: Food and Drug Administration,
Leslie Kux,
investigational human drug products for HHS.
Associate Commissioner for Policy. use in the treatment of endocrine and
[FR Doc. 2018–19067 Filed 8–31–18; 8:45 am] ACTION: Notice.
metabolic disorders, and makes
BILLING CODE 4164–01–P appropriate recommendations to the SUMMARY: The Food and Drug
Commissioner. Administration (FDA or Agency) is
The Committee shall consist of a core announcing an opportunity for public
DEPARTMENT OF HEALTH AND of 11 voting members including the comment on the proposed collection of
HUMAN SERVICES Chair. Members and the Chair are certain information by the Agency.
selected by the Commissioner or Under the Paperwork Reduction Act of
Food and Drug Administration designee from among authorities 1995 (PRA), Federal Agencies are
[Docket No. FDA–2018–N–3123] knowledgeable in the fields of required to publish notice in the
endocrinology, metabolism, Federal Register concerning each
Advisory Committee; Endocrinologic epidemiology or statistics, and related proposed collection of information and
and Metabolic Drugs Advisory specialties. Members will be invited to to allow 60 days for public comment in
Committee, Renewal serve for overlapping terms of up to 4 response to the notice. This notice
years. Almost all non-Federal members solicits comments on the creation of a
AGENCY: Food and Drug Administration,
of this committee serve as Special new collection of information entitled
HHS.
Government Employees. The core of ‘‘Generic Clearance for Quantitative
ACTION:Notice; renewal of advisory voting members may include one
committee. Testing for the Development of FDA
technically qualified member, selected Communications.’’
SUMMARY: The Food and Drug by the Commissioner or designee, who
is identified with consumer interests DATES: Submit either electronic or
Administration (FDA) is announcing the written comments on the collection of
renewal of the Endocrinologic and and is recommended by either a
consortium of consumer-oriented information by November 5, 2018.
Metabolic Drugs Advisory Committee by
organizations or other interested ADDRESSES: You may submit comments
the Commissioner of Food and Drugs
persons. In addition to the voting as follows. Please note that late,
(the Commissioner). The Commissioner
members, the Committee may include untimely filed comments will not be
has determined that it is in the public
one non-voting member who is considered. Electronic comments must
interest to renew the Endocrinologic
identified with industry interests. be submitted on or before November 5,
and Metabolic Drugs Advisory Further information regarding the 2018. The https://www.regulations.gov
Committee for an additional 2 years most recent charter and other electronic filing system will accept
beyond the charter expiration date. The information can be found at https:// comments until midnight Eastern Time
new charter will be in effect until www.fda.gov/AdvisoryCommittees/ at the end of November 5, 2018.
August 27, 2020. CommitteesMeetingMaterials/Drugs/ Comments received by mail/hand
DATES: Authority for the Endocrinologic EndocrinologicandMetabolicDrugs delivery/courier (for written/paper
and Metabolic Drugs Advisory AdvisoryCommittee/ucm100261.htm or submissions) will be considered timely
Committee will expire on August 27, by contacting the Designated Federal if they are postmarked or the delivery
2020, unless the Commissioner formally
sradovich on DSK3GMQ082PROD with NOTICES
Officer (see FOR FURTHER INFORMATION service acceptance receipt is on or
determines that renewal is in the public CONTACT). In light of the fact that no before that date.
interest. change has been made to the committee
FOR FURTHER INFORMATION CONTACT: name or description of duties, no Electronic Submissions
LaToya Bonner, Center for Drug amendment will be made to 21 CFR Submit electronic comments in the
Evaluation and Research, Food and 14.100. following way:
Drug Administration, 10903 New This document is issued under the • Federal eRulemaking Portal:
Hampshire Ave., Bldg. 31, Rm. 2417, Federal Advisory Committee Act (5 https://www.regulations.gov. Follow the
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![44890 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
• Information gathered will not be statement will be submitted to OMB Safety and Applied Nutrition, and PRA
used for the purpose of substantially along with supporting documentation specialists.
informing influential policy decisions; 2 (e.g., a copy of the survey or Respondents to this collection of
and experimental design and stimuli for information may include a wide range
• Information gathered will yield testing). of consumers and other FDA
qualitative findings; the collections will
FDA will submit individual stakeholders such as producers and
not be designed or expected to yield
quantitative collections under this manufacturers who are regulated under
statistical data or used as though the
results are generalizable to the generic clearance to OMB. Individual FDA-regulated food and cosmetic
population of study. quantitative collections will also products, dietary supplements, and
To obtain approval for a collection undergo review by FDA’s Research animal food and feed.
that meets the conditions of this generic Involving Human Subjects Committee, FDA estimates the burden of this
clearance, an abbreviated supporting senior leadership in the Center for Food collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1
Number of
Number of Total annual
Survey type responses per Total hours
respondents responses
respondent
Cognitive Interviews Screener ......................................................................... 720 1 720 60
Cognitive Interviews ......................................................................................... 144 1 144 144
Pre-test Study Screener .................................................................................. 2,400 1 2,400 199
Pre-testing Study ............................................................................................. 480 1 480 120
Self-administered Surveys/Experimental Studies Screener ............................ 75,000 1 75,000 6,225
Self-Administered Surveys/Experimental Studies ........................................... 15,000 1 15,000 3,750
Total .......................................................................................................... ........................ ........................ ........................ 10,498
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The total estimated annual burden is announcing the fees we will assess for (Pub. L. 104–134, amended by Pub. L.
10,498 hours. Current estimates are issuing export certificates for food for 104–180) amended sections 801 and 802
based on both historical numbers of human consumption, with the of the Federal Food, Drug, and Cosmetic
participants from past projects as well exception of dietary supplements, Act (the FD&C Act) (21 U.S.C. 381 and
as estimates for projects to be conducted medical foods, and foods for special 382). As a result of the 1996
in the next 3 years. The number of dietary use. The FDA Food Safety amendments, section 801(e)(4) of the
participants to be included in each new Modernization Act (FSMA) of 2011 FD&C Act provides that persons
survey will vary, depending on the authorizes us to charge fees to cover our exporting a drug, animal drug, or device
nature of the compliance efforts and the costs associated with issuing export may request FDA to certify that the
target audience. certificates for food. This notice product meets the requirements of
Dated: August 28, 2018. provides the fee schedule for issuing section 801(e)(1), section 802, or other
Leslie Kux,
these certificates and the basis for the applicable requirements of the FD&C
fees. We have not previously exercised Act. Upon a showing that the product
Associate Commissioner for Policy.
our FSMA authority to collect fees for meets the applicable requirements, the
[FR Doc. 2018–19088 Filed 8–31–18; 8:45 am]
export certificates issued for food for law provides that FDA shall issue
BILLING CODE 4164–01–P human consumption. export certification within 20 days of
DATES: The fees described in this the receipt of a request for such
document for export certificates for food certification. The law also authorizes us
DEPARTMENT OF HEALTH AND
for human consumption, with the to charge up to $175 for each
HUMAN SERVICES
exception of dietary supplements, certification issued within the 20-day
Food and Drug Administration medical foods, and foods for special period.
dietary use, will be effective October 1, In January 2011, section 801(e)(4) of
[Docket No. FDA–2018–N–2700] 2018. the FD&C Act was further amended by
FOR FURTHER INFORMATION CONTACT: Kate FSMA (Pub. L. 111–353) to authorize
Food for Human Consumption; Export FDA to issue, and charge fees for, export
Meck, International Affairs Staff, Center
Certificates; Food and Drug certificates for food. Under section
for Food Safety and Applied Nutrition
Administration Food Safety 801(e)(4)(C) of the FD&C Act, an export
(HFS–550), Food and Drug
Modernization Act of 2011; certification can be made in such form
Administration, 5001 Campus Dr.,
Certification Fees (including a publicly available listing)
College Park, MD 20740, 240–402–2307,
AGENCY: Food and Drug Administration, CFSANExportCertification@fda.hhs.gov. as FDA determines appropriate.
HHS. SUPPLEMENTARY INFORMATION: This notice focuses on the fees to be
sradovich on DSK3GMQ082PROD with NOTICES
ACTION: Notice. assessed with respect to export
I. Background certificates issued by the Center for
SUMMARY: The Food and Drug In April 1996, the ‘‘FDA Export Food Safety and Applied Nutrition
Administration (FDA or we) is Reform and Enhancement Act of 1996’’ (CFSAN) for food for human
2 As defined in OMB and agency Information dissemination of the information will have or does public policies or important private sector
Quality Guidelines, ‘‘influential’’ means that ‘‘an have a clear and substantial impact on important decisions.’’
agency can reasonably determine that
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Document Created: 2018-09-01 03:00:00
Document Modified: 2018-09-01 03:00:00
| 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 | Submit either electronic or written comments on the collection of information by November 5, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 44888 |
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