Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealer's Certificate, 16512-16513 [2013-05970]
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Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices
this list could be delayed or prevented
by Chilean authorities from entering
commerce in Chile. The guidance
explains what information firms should
submit to FDA in order to be considered
for inclusion on the list and what
criteria FDA intends to use to determine
eligibility for placement on the list. The
document also explains how FDA
intends to update the list and how FDA
intends to communicate any new
information to Chile. Finally, the
guidance notes that FDA considers the
information on this list, which is
provided voluntarily with the
understanding that it will be posted on
FDA’s Web site and communicated to,
and possibly further disseminated by,
Chile, to be information that is not
protected from disclosure under 5
U.S.C. 552(b)(4). Under the guidance,
FDA recommends that U.S. firms that
want to be placed on the list send the
following information to FDA: Name
and address of the firm and the
manufacturing plant; name, telephone
number, and email address (if available)
of the contact person; a list of products
presently shipped and expected to be
shipped in the next 3 years; identities of
Agencies that inspect the plant and the
date of last inspection; plant number
and copy of last inspection notice; and,
if other than an FDA inspection, copy of
last inspection report. FDA requests that
this information be updated every 2
years.
In the Federal Register of November
15, 2012 (77 FR 68128), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
New written requests to be placed on the list .....................
Biannual update ...................................................................
Occasional updates .............................................................
25
88
25
1
1
1
25
88
25
1.5
1.0
0.5
38
88
13
Total ..............................................................................
........................
........................
........................
........................
139
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biannual updates
and occasional updates is based on the
FDA’s experience maintaining the list
over the past 7 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
On average, over the last 3 years, the
list contained approximately 176 firms.
FDA estimates that, each year,
approximately 25 new firms will apply
to be added to the list. In any given year,
some firms choose not to resubmit their
information. These firms are removed
from the list quarterly. This occurrence
results in the number of firms to remain
at approximately 176. We estimate that
a firm will require 1.5 hours to read the
guidance, gather the information
needed, and to prepare a
communication to FDA that contains
the information and requests that the
firm be placed on the list for a total of
37.5 hours, rounded to 38. Under the
guidance, every 2 years each producer
on the list must provide updated
information in order to remain on the
list. FDA estimates that each year
approximately half of the firms on the
list, 88 firms (176 × 0.5 = 88), will
resubmit the information to remain on
the list. We estimate that a firm already
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17:37 Mar 14, 2013
Jkt 229001
on the list will require 1.0 hours to
biannually update and resubmit the
information to FDA, including time
reviewing the information and
corresponding with FDA, for a total of
88 hours. In addition, FDA expects that,
each year, approximately 25 firms will
need to submit an occasional update
and each firm will require 0.5 hours to
prepare a communication to FDA
reporting the change, for a total of 12.5
hours, rounded to 13.
Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06017 Filed 3–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1108]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Interstate Shellfish
Dealer’s 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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 April 15,
2013.
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. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400, Rockville, MD 20850, 301–796–
5733, domini.bean@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 section 243 of the Public
Health Service Act (42 U.S.C. 243), FDA
is required to cooperate with and aid
State and local authorities in the
enforcement of their health regulations
E:\FR\FM\15MRN1.SGM
15MRN1
16513
Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices
and is authorized to assist States in the
prevention and suppression of
communicable diseases. Under this
authority, FDA participates 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.’’ FDA uses 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 FDA 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 November
15, 2012 (77 FR 68129), FDA published
a 60-day notice requesting public
comment on the proposed extension of
this collection of information. FDA
received one letter in response to the
notice, containing multiple comments
on the testing methods used by certified
shellfish processors in the NSSP. These
comments were outside the scope of the
four collection-of-information topics on
which the notice requested comments,
and will not be discussed in this
document. FDA estimates the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submission of Interstate Shellfish Dealer’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.
FDA estimates that 40 respondents
will submit 2,280 Interstate Shellfish
Dealer’s Certificates annually, for a total
burden of 228 hours (2,280 submissions
× 0.10 hours = 228 hours). This estimate
is based on FDA’s experience and the
number of certificates received in the
past 3 years.
Dated: March 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05970 Filed 3–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Application of Advances in Nucleic
Acid and Protein Based Detection
Methods to Multiplex Detection of
Transfusion-Transmissible Agents and
Blood Cell Antigens in Blood
Donations; Public Workshop
AGENCY:
Food and Drug Administration,
srobinson on DSK4SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Application of Advances in
Nucleic Acid and Protein Based
Detection Methods to Multiplex
Detection of Transfusion-Transmissible
Agents and Blood Cell Antigens in
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17:37 Mar 14, 2013
Jkt 229001
Blood Donations.’’ The purpose of this
public workshop is to discuss research
and development of multiplex assays
and the use of these tests in blood donor
screening and blood cell antigen typing.
The public workshop has been planned
in partnership with the AABB (formerly
known as the American Association of
Blood Banks), Advanced Medical
Technology Association (AdvaMed),
America’s Blood Centers, Department of
Defense, Department of Health and
Human Services Office of the Assistant
Secretary for Health, and the National
Heart, Lung and Blood Institute,
National Institutes of Health. The public
workshop will include presentations
and panel discussions by experts from
academic institutions, blood
establishments, industry, and
government agencies.
Date and Time: The public workshop
will be held on April 10, 2013, from 8
a.m. to 5:30 p.m., and April 11, 2013,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held in the Main Auditorium,
Natcher Conference Center, National
Institutes of Health, Bldg. 45, Bethesda,
MD 20892.
Contact Person: Jennifer Scharpf,
Center for Biologics Evaluation and
Research (HFM–300), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6128, FAX: 301–827–2843,
email:
CBEROBRRWorkshops@fda.hhs.gov.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Registration: Mail, fax, or email your
registration information (including
name, title, firm name, address,
telephone and fax numbers, and email
address) to Jennifer Scharpf (see Contact
Person) by April 1, 2013. There is no
registration fee for the public workshop.
Early registration is recommended
because seating is limited. Registration
on the day of the public workshop will
be provided on a space available basis
beginning at 7:30 a.m. If you need
special accommodations due to a
disability, please contact Jennifer
Scharpf (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION: The
objectives of the workshop are to review
the status of multiplex platforms and
the technological advances in gene
based and protein based pathogen and
blood cell antigen detection methods
and to discuss the scientific pathways to
support the development of multiplex
assays to screen blood donors for bloodborne pathogens and blood cell antigen
typing.
The first day of this workshop will
include presentations and panel
discussions on the following topics: (1)
Blood safety and infectious agents, (2)
advances in blood-borne pathogen
detection, and (3) molecular DNA-based
typing of blood cell antigens.
The second day of the workshop will
include presentations and discussion on
the following topics: (1) Highly
multiplexed technologies in blood
donor screening; (2) bioinformatics, data
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16512-16513]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1108]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Interstate Shellfish
Dealer's 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 April
15, 2013.
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.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400,
Rockville, MD 20850, 301-796-5733, domini.bean@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 section 243 of the Public Health Service Act (42 U.S.C. 243),
FDA is required to cooperate with and aid State and local authorities
in the enforcement of their health regulations
[[Page 16513]]
and is authorized to assist States in the prevention and suppression of
communicable diseases. Under this authority, FDA participates 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.'' FDA uses 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 FDA 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 November 15, 2012 (77 FR 68129), FDA
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. FDA received one letter in
response to the notice, containing multiple comments on the testing
methods used by certified shellfish processors in the NSSP. These
comments were outside the scope of the four collection-of-information
topics on which the notice requested comments, and will not be
discussed in this document. FDA estimates 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 Average burden Total hours
respondents respondent responses per 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.
FDA estimates 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 FDA's experience and the number of certificates received in
the past 3 years.
Dated: March 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05970 Filed 3-14-13; 8:45 am]
BILLING CODE 4160-01-P
