81 FR 74453 - The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 207 (October 26, 2016)

Page Range		74453-74453
FR Document		2016-25853

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.

Federal Register, Volume 81 Issue 207 (Wednesday, October 26, 2016)

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Page 74453]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25853]


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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.

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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

Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices 74453

year. We estimated that these SKUs are of OTC sunscreen drug products would equal to 0.1. In the 1999 labeling final
marketed by 300 manufacturers. We be marketed each year (77 FR 27230 at rule, we estimated that a request for
estimated that the preparation of 27234). We estimate that these 60 SKUs deferral or exemption would require 24
labeling for new OTC drug products would be marketed by 20 hours to complete (64 FR 13254 at
would require 12 hours to prepare, manufacturers. We estimate that 13276). We continue to estimate that
complete, and review prior to approximately 12 hours would be spent this type of response will require
submitting the new labeling to us. Based on each label, based on the most recent approximately 24 hours. Multiplying
on this estimate, the annual reporting estimate used for other OTC drug the annual frequency of response (0.1)
burden for this type of labeling is products to comply with the 1999 Drug by the number of hours per response
approximately 10,800 hours. Facts labeling final rule, including
(24) gives a total response time for
All currently marketed sunscreen public comments received on this
products are required to be in requesting exemption of deferral equal
estimate in 2010 that addressed
compliance with the Drug Facts labeling sunscreens. to 3 hours.
requirements in § 201.66, and thus will In determining the burden for In the Federal Register of April 1,
incur no further burden under the § 201.66, it is also important to consider 2016 (81 FR 18861), we published a 60-
information collection provisions in the exemptions or deferrals of the regulation day notice requesting public comment
1999 labeling final rule. However, a new allowed products under § 201.66(e). on the proposed extension of this
OTC sunscreen drug product, like any Since publication of the 1999 labeling collection of information. No comments
new OTC drug product, will be subject final rule, we have received only one were received.
to a one-time burden to comply with request for exemption or deferral. One
FDA estimates the burden of this
Drug Facts labeling requirements in response over a 10-year period equates
collection of information as follows:
§ 201.66. We estimate that 60 new SKUs to an annual frequency of response

TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent

201.66(c) and (d) for new OTC drug products .................... 300 3 900 12 10,800
201.66(c) and (d) for new OTC sunscreen products .......... 20 3 60 12 720
201.66(e) .............................................................................. 1 0.125 .125 24 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. after the publication of the notice of the DEPARTMENT OF HEALTH AND
Leslie Kux, workshop. This document corrects that HUMAN SERVICES
Associate Commissioner for Policy. error.
[FR Doc. 2016–25854 Filed 10–25–16; 8:45 am] Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P Chris Nguyen, Center for Biologics [Docket No. FDA–2013–N–0730]
Evaluation and Research, Food and
Drug Administration, 10903 New Agency Information Collection
DEPARTMENT OF HEALTH AND Hampshire Ave., Bldg. 71, Rm. 4124, Activities; Submission for Office of
HUMAN SERVICES Silver Spring, MD 20993–0002; or Management and Budget Review;
Cynthia Whitmarsh, Center for Biologics Comment Request; Threshold of
Food and Drug Administration Regulation for Substances Used in
Evaluation and Research, Food and
[Docket No. FDA–2016–N–0001] Drug Administration, 10903 New Food-Contact Articles
Hampshire Ave., Bldg. 71, Rm. 4122, AGENCY: Food and Drug Administration,
The Sentinel Post-Licensure Rapid Silver Spring, MD 20993–0002. HHS.
Immunization Safety Monitoring
Program; Public Workshop; Correction SUPPLEMENTARY INFORMATION: In the ACTION: Notice.
Federal Register of September 1, 2016,
AGENCY: Food and Drug Administration, in FR Doc. 2016–21046, on page 60357, SUMMARY: The Food and Drug
HHS. the following correction is made: Administration (FDA) is announcing
that a proposed collection of
ACTION: Notice of public workshop; On page 60357, in the third column information has been submitted to the
correction. under the SUPPLEMENTARY INFORMATION Office of Management and Budget
caption, the fifth sentence in the second (OMB) for review and clearance under
SUMMARY: The Food and Drug paragraph is corrected to read ‘‘More
Administration (FDA) is correcting a the Paperwork Reduction Act of 1995.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

information can be found at: https://
notice that appeared in the Federal DATES: Fax written comments on the
www.sentinelsystem.org/vaccines-blood-
Register of Thursday, September 1, 2016 biologics.’’ collection of information by November
(81 FR 60357). The document 25, 2016.
announced a public workshop entitled Dated: October 20, 2016. ADDRESSES: To ensure that comments on
‘‘The Sentinel Post-Licensure Rapid Leslie Kux, the information collection are received,
Immunization Safety Monitoring Associate Commissioner for Policy. OMB recommends that written
(PRISM) Program.’’ The document was [FR Doc. 2016–25853 Filed 10–25–16; 8:45 am] comments be faxed to the Office of
published with a Web site that changed BILLING CODE 4164–01–P Information and Regulatory Affairs,

VerDate Sep<11>2014 18:25 Oct 25, 2016 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1

Document Created: 2016-10-26 02:18:19
Document Modified: 2016-10-26 02:18:19

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 of public workshop; correction.
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.
FR Citation		81 FR 74453

81 FR 74453 - The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 207 (October 26, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration