The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop; Correction, 74453 [2016-25853]
Download as PDF
74453
Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices
year. We estimated that these SKUs are
marketed by 300 manufacturers. We
estimated that the preparation of
labeling for new OTC drug products
would require 12 hours to prepare,
complete, and review prior to
submitting the new labeling to us. Based
on this estimate, the annual reporting
burden for this type of labeling is
approximately 10,800 hours.
All currently marketed sunscreen
products are required to be in
compliance with the Drug Facts labeling
requirements in § 201.66, and thus will
incur no further burden under the
information collection provisions in the
1999 labeling final rule. However, a new
OTC sunscreen drug product, like any
new OTC drug product, will be subject
to a one-time burden to comply with
Drug Facts labeling requirements in
§ 201.66. We estimate that 60 new SKUs
of OTC sunscreen drug products would
be marketed each year (77 FR 27230 at
27234). We estimate that these 60 SKUs
would be marketed by 20
manufacturers. We estimate that
approximately 12 hours would be spent
on each label, based on the most recent
estimate used for other OTC drug
products to comply with the 1999 Drug
Facts labeling final rule, including
public comments received on this
estimate in 2010 that addressed
sunscreens.
In determining the burden for
§ 201.66, it is also important to consider
exemptions or deferrals of the regulation
allowed products under § 201.66(e).
Since publication of the 1999 labeling
final rule, we have received only one
request for exemption or deferral. One
response over a 10-year period equates
to an annual frequency of response
equal to 0.1. In the 1999 labeling final
rule, we estimated that a request for
deferral or exemption would require 24
hours to complete (64 FR 13254 at
13276). We continue to estimate that
this type of response will require
approximately 24 hours. Multiplying
the annual frequency of response (0.1)
by the number of hours per response
(24) gives a total response time for
requesting exemption of deferral equal
to 3 hours.
In the Federal Register of April 1,
2016 (81 FR 18861), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
201.66(c) and (d) for new OTC drug products ....................
201.66(c) and (d) for new OTC sunscreen products ..........
201.66(e) ..............................................................................
300
20
1
3
3
0.125
900
60
.125
12
12
24
10,800
720
3
Total ..............................................................................
........................
........................
........................
........................
11,523
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
after the publication of the notice of the
workshop. This document corrects that
error.
[FR Doc. 2016–25854 Filed 10–25–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
Chris Nguyen, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4124,
Silver Spring, MD 20993–0002; or
Cynthia Whitmarsh, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4122,
Silver Spring, MD 20993–0002.
[Docket No. FDA–2013–N–0730]
In the
Federal Register of September 1, 2016,
in FR Doc. 2016–21046, on page 60357,
the following correction is made:
On page 60357, in the third column
under the SUPPLEMENTARY INFORMATION
caption, the fifth sentence in the second
paragraph is corrected to read ‘‘More
information can be found at: https://
www.sentinelsystem.org/vaccines-bloodbiologics.’’
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
Program; Public Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
correction.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Thursday, September 1, 2016
(81 FR 60357). The document
announced a public workshop entitled
‘‘The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
(PRISM) Program.’’ The document was
published with a Web site that changed
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:25 Oct 25, 2016
Jkt 241001
SUPPLEMENTARY INFORMATION:
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25853 Filed 10–25–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
AGENCY:
Food and Drug Administration,
HHS.
Notice.
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 November
25, 2016.
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,
SUMMARY:
E:\FR\FM\26OCN1.SGM
26OCN1
Agencies
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Page 74453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25853]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
The Sentinel Post-Licensure Rapid Immunization Safety Monitoring
Program; Public Workshop; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Thursday, September 1, 2016
(81 FR 60357). The document announced a public workshop entitled ``The
Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM)
Program.'' The document was published with a Web site that changed
after the publication of the notice of the workshop. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT: Chris Nguyen, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4124, Silver Spring, MD 20993-0002; or
Cynthia Whitmarsh, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4122,
Silver Spring, MD 20993-0002.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 1,
2016, in FR Doc. 2016-21046, on page 60357, the following correction is
made:
On page 60357, in the third column under the SUPPLEMENTARY
INFORMATION caption, the fifth sentence in the second paragraph is
corrected to read ``More information can be found at: https://www.sentinelsystem.org/vaccines-blood-biologics.''
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25853 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P