Advisory Commission on Childhood Vaccines Meeting; Correction, 19314 [2023-06673]
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Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
that are broadcast through media such
as television, radio, or telephone
communications systems must disclose
the major risks from the product’s
package labeling in either the audio or
audio and visual parts of the
presentation (§ 202.1(e)(1)); this
disclosure is known as the ‘‘major
statement.’’ If a broadcast advertisement
omits the major statement, or if the
major statement minimizes the risks
associated with the use of the drug, the
advertisement could render the drug
misbranded in violation of the FD&C
Act, (21 U.S.C. 352(n) and section 201
of the FD&C Act (21 U.S.C. 321(n))), and
FDA’s implementing regulations at
§ 202.1(e).
We are revising the information
collection to include recommendations
found in Agency guidance. The
guidance document entitled,
‘‘Presenting Quantitative Efficacy and
Risk Information in Direct-to-Consumer
[DTC] Promotional Labeling and
Advertisements,’’ provides content and
format recommendations for DTC
promotional labeling and
advertisements (promotional
communications) that present
quantitative efficacy and risk
information. The guidance document
was developed consistent with Agency
good guidance practices regulations in
21 CFR 10.115, which provide for
comment at any time. The draft
guidance document, issued on October
17, 2018, is available at https://
www.fda.gov/media/117573/download
and in docket FDA–2018–D–2613. FDA
also maintains a searchable guidance
database at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents to facilitate access
to these documents.
The guidance document recommends
specific content elements pertaining to
the presentation of quantitative efficacy
and risk information in DTC
promotional communications. The
guidance also discusses formatting
considerations related to the use of
visual aids that display quantitative
efficacy or risk information in DTC
promotional communications. The
guidance document explains that the
information collection applies to the
third-party disclosure of information
pertaining to FDA-regulated products
that contain quantitative efficacy or risk
information and discusses the Agency’s
current thinking with regard to this
topic.
In the Federal Register of October 17,
2018 (83 FR 52484), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received regarding FDA’s need for the
information, the accuracy of our burden
estimate, or ways to minimize burden.
Although we are preparing to finalize
the guidance document to clarify
considerations for quantitative efficacy
or risk presentations across various
media types and provide additional
explanation regarding specific concepts
and examples that were included in the
draft guidance, none of the revisions
pertain to the information collection
recommendations discussed in our 60day notice.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Guidance document recommendations
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
‘‘Presenting Quantitative Efficacy and Risk Information in
Direct-to-Consumer Promotional Labeling and Advertisements’’ as recommended in Section III of the guidance
465
43
19,995
2
39,990
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
According to available data,
approximately 465 firms prepare 49,000
FDA-regulated DTC promotional
communications annually. Of these
communications, we assume 40 percent
contain a disclosure of quantitative
efficacy or risk information. Based on
this information, we calculate that firms
each disseminate 43 DTC promotional
communications that contain a
disclosure of quantitative efficacy or
risk information annually. Based on our
experience reviewing FDA-regulated
promotional communications for drugs,
we estimate respondents spend an
average of 2 hours to prepare a
disclosure as recommended in the
guidance. We therefore estimate 19,995
disclosures and a burden of 39,990
hours annually.
Dated: March 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06707 Filed 3–30–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines Meeting; Correction
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice; correction.
AGENCY:
HRSA published a notice in
the Federal Register on December 20,
2022, concerning 2023 calendar year
meetings of the Advisory Commission
on Childhood Vaccines (ACCV). The
document contained incorrect dates for
future meetings. The remaining 2023
ACCV meetings will be held on
September 7, 2023, 10:00 a.m. Eastern
time (ET)–4:00 p.m. ET and September
8, 2023, 10:00 a.m. ET–4:00 p.m. ET.
FOR FURTHER INFORMATION CONTACT: Pita
Gomez, Principal Staff Liaison, Division
of Injury Compensation Programs,
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 9990
HRSA, 5600 Fishers Lane, 08N186B,
Rockville, Maryland 20857; (800) 338–
2382; or ACCV@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of December
20, 2022, FR Doc. 2022–27543, page
77852, column 3, correct the Dates
caption to read: ‘‘The ACCV meetings
will be held on:
• March 1, 2023, 10:00 a.m. Eastern
Time (ET)–4:00 p.m. ET;
• March 2, 2023, 10:00 a.m. ET–4:00
p.m. ET;
• September 7, 2023, 10:00 a.m. ET–
4:00 p.m. ET;
• September 8, 2023, 10:00 a.m. ET–
4:00 p.m. ET.’’
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–06673 Filed 3–30–23; 8:45 am]
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[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Page 19314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06673]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Commission on Childhood Vaccines Meeting; Correction
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice; correction.
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SUMMARY: HRSA published a notice in the Federal Register on December
20, 2022, concerning 2023 calendar year meetings of the Advisory
Commission on Childhood Vaccines (ACCV). The document contained
incorrect dates for future meetings. The remaining 2023 ACCV meetings
will be held on September 7, 2023, 10:00 a.m. Eastern time (ET)-4:00
p.m. ET and September 8, 2023, 10:00 a.m. ET-4:00 p.m. ET.
FOR FURTHER INFORMATION CONTACT: Pita Gomez, Principal Staff Liaison,
Division of Injury Compensation Programs, HRSA, 5600 Fishers Lane,
08N186B, Rockville, Maryland 20857; (800) 338-2382; or [email protected].
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of December 20, 2022, FR Doc. 2022-27543,
page 77852, column 3, correct the Dates caption to read: ``The ACCV
meetings will be held on:
March 1, 2023, 10:00 a.m. Eastern Time (ET)-4:00 p.m. ET;
March 2, 2023, 10:00 a.m. ET-4:00 p.m. ET;
September 7, 2023, 10:00 a.m. ET-4:00 p.m. ET;
September 8, 2023, 10:00 a.m. ET-4:00 p.m. ET.''
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-06673 Filed 3-30-23; 8:45 am]
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