80 FR 68323 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealers Certificate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 213 (November 4, 2015)

Page Range		68323-68323
FR Document		2015-28109

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.

Federal Register, Volume 80 Issue 213 (Wednesday, November 4, 2015)

[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Notices]
[Page 68323]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-28109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0232]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Interstate Shellfish
Dealers Certificate

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
December 4, 2015.

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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0021 and
title ``Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Interstate Shellfish
Dealers Certificate.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

Interstate Shellfish Dealer's Certificate

OMB Control Number 0910-0021--Extension

Under 42 U.S.C. 243, we are required to cooperate with and aid
State and local authorities in the enforcement of their health
regulations and are authorized to assist States in the prevention and
suppression of communicable diseases. Under this authority, we
participate with State regulatory agencies, some foreign nations, and
the molluscan shellfish industry in the National Shellfish Sanitation
Program (NSSP).
NSSP is a voluntary, cooperative program to promote the safety of
molluscan shellfish by providing for the classification and patrol of
shellfish growing waters and for the inspection and certification of
shellfish processors. Each participating State and foreign nation
monitors its molluscan shellfish processors and issues certificates for
those that meet the State or foreign shellfish control authority's
criteria. Each participating State and nation provides a certificate of
its certified shellfish processors to FDA on Form FDA 3038,
``Interstate Shellfish Dealer's Certificate.'' We use this information
to publish the ``Interstate Certified Shellfish Shippers List,'' a
monthly comprehensive listing of all molluscan shellfish processors
certified under the cooperative program. If we did not collect the
information necessary to compile this list, participating States would
not be able to identify and keep out shellfish processed by uncertified
processors in other States and foreign nations. Consequently, NSSP
would not be able to control the distribution of uncertified and
possibly unsafe shellfish in interstate commerce, and its effectiveness
would be nullified.
In the Federal Register of August 20, 2015 (80 FR 50640), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA Form No. Number of responses per Total annual Avg. burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Interstate Shellfish Dealer's 3038 40 57 2,280 0.10 228
Certificate......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate that 40 respondents will submit 2,280 Interstate
Shellfish Dealer's Certificates annually, for a total burden of 228
hours (2,280 submissions x 0.10 hours = 228 hours). This estimate is
based on our experience with this information collection and the number
of certificates received in the past 3 years, which has remained
constant.

Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28109 Filed 11-3-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Notices 68323

Comments should be received by DATES: Fax written comments on the regulatory agencies, some foreign
December 4, 2015 in order to be collection of information by December nations, and the molluscan shellfish
included in the final report. 4, 2015. industry in the National Shellfish
FOR FURTHER INFORMATION CONTACT: ADDRESSES: To ensure that comments on Sanitation Program (NSSP).
Clare Barnett, Administration for the information collection are received, NSSP is a voluntary, cooperative
Community Living, Administration on OMB recommends that written program to promote the safety of
Intellectual and Developmental comments be faxed to the Office of molluscan shellfish by providing for the
Disabilities, Office of Program Support, Information and Regulatory Affairs, classification and patrol of shellfish
One Massachusetts Avenue NW., Room OMB, Attn: FDA Desk Officer, FAX: growing waters and for the inspection
4204, Washington, DC 20201, 202–357– 202–395–7285, or emailed to oira_ and certification of shellfish processors.
3426. submission@omb.eop.gov. All Each participating State and foreign
comments should be identified with the nation monitors its molluscan shellfish
Dated: October 29, 2015. OMB control number 0910–0021 and processors and issues certificates for
Kathy Greenlee, title ‘‘Agency Information Collection those that meet the State or foreign
Administrator & Assistant Secretary for Activities; Submission for Office of shellfish control authority’s criteria.
Aging. Management and Budget Review; Each participating State and nation
[FR Doc. 2015–28058 Filed 11–3–15; 8:45 am] Comment Request; Interstate Shellfish provides a certificate of its certified
BILLING CODE 4154–01–P Dealers Certificate.’’ Also include the shellfish processors to FDA on Form
FDA docket number found in brackets FDA 3038, ‘‘Interstate Shellfish Dealer’s
in the heading of this document. Certificate.’’ We use this information to
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: FDA publish the ‘‘Interstate Certified
HUMAN SERVICES PRA Staff, Office of Operations, Food Shellfish Shippers List,’’ a monthly
and Drug Administration, 8455 comprehensive listing of all molluscan
Food and Drug Administration
Colesville Rd., COLE–14526, Silver shellfish processors certified under the
Spring, MD 20993–0002, PRAStaff@ cooperative program. If we did not
[Docket No. FDA–2009–N–0232] fda.hhs.gov. collect the information necessary to
Agency Information Collection SUPPLEMENTARY INFORMATION: In compile this list, participating States
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA would not be able to identify and keep
Management and Budget Review; has submitted the following proposed out shellfish processed by uncertified
Comment Request; Interstate Shellfish collection of information to OMB for processors in other States and foreign
Dealers Certificate review and clearance. nations. Consequently, NSSP would not
be able to control the distribution of
Interstate Shellfish Dealer’s Certificate uncertified and possibly unsafe shellfish
AGENCY: Food and Drug Administration,
HHS. OMB Control Number 0910–0021— in interstate commerce, and its
Extension effectiveness would be nullified.
ACTION: Notice.
Under 42 U.S.C. 243, we are required In the Federal Register of August 20,
SUMMARY: The Food and Drug to cooperate with and aid State and 2015 (80 FR 50640), FDA published a
Administration (FDA) is announcing local authorities in the enforcement of 60-day notice requesting public
that a proposed collection of their health regulations and are comment on the proposed collection of
information has been submitted to the authorized to assist States in the information. No comments were
Office of Management and Budget prevention and suppression of received.
(OMB) for review and clearance under communicable diseases. Under this We estimate the burden of this
the Paperwork Reduction Act of 1995. authority, we participate with State collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Avg.
Number of Total annual
Activity FDA Form No. responses per burden per Total hours
respondents responses
respondent response

Submission of Interstate Shellfish Deal-
er’s Certificate ...................................... 3038 40 57 2,280 0.10 228
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate that 40 respondents will Dated: October 30, 2015. DEPARTMENT OF HEALTH AND
submit 2,280 Interstate Shellfish Leslie Kux, HUMAN SERVICES
Dealer’s Certificates annually, for a total Associate Commissioner for Policy.
burden of 228 hours (2,280 submissions [FR Doc. 2015–28109 Filed 11–3–15; 8:45 am] Health Resources and Services
× 0.10 hours = 228 hours). This estimate Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES

BILLING CODE 4164–01–P
is based on our experience with this
information collection and the number National Vaccine Injury Compensation
of certificates received in the past 3 Program; List of Petitions Received
years, which has remained constant.
AGENCY:Health Resources and Services
Administration, HHS.
ACTION: Notice.

VerDate Sep<11>2014 17:00 Nov 03, 2015 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\04NON1.SGM 04NON1

Document Created: 2018-03-01 11:28:17
Document Modified: 2018-03-01 11:28:17

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 December 4, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 68323

80 FR 68323 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealers Certificate

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 213 (November 4, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration