80 FR 50640 - Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealers Certificate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 161 (August 20, 2015)

Page Range		50640-50641
FR Document		2015-20562

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Interstate Shellfish Dealers Certificate.

Federal Register, Volume 80 Issue 161 (Thursday, August 20, 2015)

[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50640-50641]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20562]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Comment Request; Interstate Shellfish Dealers 
Certificate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of the Interstate Shellfish Dealers Certificate.

DATES: Submit either electronic or written comments on the collection 
of information by October 19, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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.
    We estimate the burden of this collection of information as 
follows:

[[Page 50641]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Number of
                Activity                   FDA Form No.      Number of      responses per     Total annual       Average burden per        Total hours
                                                            respondents       respondent       responses              response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Interstate Shellfish                 3038               40               57            2,280   0.10......................             228
 Dealer's Certificate.                                                                                       (6 minutes)...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20562 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P

50640 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices

hearing session. The contact person will including each proposed extension of an collection of information, including the
notify interested persons regarding their existing collection of information, and validity of the methodology and
request to speak by October 13, 2015. to allow 60 days for public comment in assumptions used; (3) ways to enhance
Persons attending FDA’s advisory response to the notice. This notice the quality, utility, and clarity of the
committee meetings are advised that the solicits comments on the information information to be collected; and (4)
Agency is not responsible for providing collection provisions of the Interstate ways to minimize the burden of the
access to electrical outlets. Shellfish Dealers Certificate. collection of information on
FDA welcomes the attendance of the DATES: Submit either electronic or respondents, including through the use
public at its advisory committee written comments on the collection of of automated collection techniques,
meetings and will make every effort to information by October 19, 2015. when appropriate, and other forms of
accommodate persons with physical ADDRESSES: Submit electronic information technology.
disabilities or special needs. If you comments on the collection of Interstate Shellfish Dealer’s Certificate
require special accommodations due to information to http://
a disability, please contact Kalyani www.regulations.gov. Submit written OMB Control Number 0910–0021—
Bhatt at least 7 days in advance of the comments on the collection of Extension
meeting. information to the Division of Dockets
FDA is committed to the orderly Under 42 U.S.C. 243, we are required
Management (HFA–305), Food and Drug
conduct of its advisory committee to cooperate with and aid State and
Administration, 5630 Fishers Lane, Rm.
meetings. Please visit our Web site at local authorities in the enforcement of
1061, Rockville, MD 20852. All
http://www.fda.gov/ their health regulations and are
comments should be identified with the
AdvisoryCommittees/ docket number found in brackets in the authorized to assist States in the
AboutAdvisoryCommittees/ heading of this document. prevention and suppression of
ucm111462.htm for procedures on communicable diseases. Under this
FOR FURTHER INFORMATION CONTACT: FDA
public conduct during advisory authority, we participate with State
PRA Staff, Office of Operations, Food
committee meetings. regulatory agencies, some foreign
and Drug Administration, 8455
Notice of this meeting is given under nations, and the molluscan shellfish
Colesville Rd., COLE–14526, Silver
the Federal Advisory Committee Act (5 industry in the National Shellfish
Spring, MD 20993–0002, PRAStaff@
U.S.C. app. 2). Sanitation Program (NSSP).
fda.hhs.gov.
NSSP is a voluntary, cooperative
Dated: August 14, 2015. SUPPLEMENTARY INFORMATION: Under the
program to promote the safety of
Jill Hartzler Warner, PRA (44 U.S.C. 3501–3520), Federal molluscan shellfish by providing for the
Associate Commissioner for Special Medical Agencies must obtain approval from the classification and patrol of shellfish
Programs. Office of Management and Budget growing waters and for the inspection
[FR Doc. 2015–20540 Filed 8–19–15; 8:45 am] (OMB) for each collection of and certification of shellfish processors.
BILLING CODE 4164–01–P information they conduct or sponsor. Each participating State and foreign
‘‘Collection of information’’ is defined
nation monitors its molluscan shellfish
in 44 U.S.C. 3502(3) and 5 CFR
processors and issues certificates for
DEPARTMENT OF HEALTH AND 1320.3(c) and includes Agency requests
those that meet the State or foreign
HUMAN SERVICES or requirements that members of the
shellfish control authority’s criteria.
public submit reports, keep records, or
Food and Drug Administration Each participating State and nation
provide information to a third party.
provides a certificate of its certified
[Docket No. FDA–2009–N–0232] Section 3506(c)(2)(A) of the PRA (44
shellfish processors to FDA on Form
U.S.C. 3506(c)(2)(A)) requires Federal
FDA 3038, ‘‘Interstate Shellfish Dealer’s
Agency Information Collection Agencies to provide a 60-day notice in
Certificate.’’ We use this information to
Activities; Proposed Collection; the Federal Register concerning each
proposed collection of information, publish the ‘‘Interstate Certified
Comment Request; Comment Request; Shellfish Shippers List,’’ a monthly
Interstate Shellfish Dealers Certificate including each proposed extension of an
existing collection of information, comprehensive listing of all molluscan
AGENCY: Food and Drug Administration, before submitting the collection to OMB shellfish processors certified under the
HHS. for approval. To comply with this cooperative program. If we did not
requirement, we are publishing notice of collect the information necessary to
ACTION: Notice.
the proposed collection of information compile this list, participating States
SUMMARY: The Food and Drug set forth in this document. would not be able to identify and keep
Administration (FDA or we) is With respect to the following out shellfish processed by uncertified
announcing an opportunity for public collection of information, we invite processors in other States and foreign
comment on our proposed collection of comments on these topics: (1) Whether nations. Consequently, NSSP would not
certain information by the Agency. the proposed collection of information be able to control the distribution of
Under the Paperwork Reduction Act of is necessary for the proper performance uncertified and possibly unsafe shellfish
1995 (the PRA), Federal Agencies are of FDA’s functions, including whether in interstate commerce, and its
required to publish notice in the the information will have practical effectiveness would be nullified.
Federal Register concerning each utility; (2) the accuracy of FDA’s We estimate the burden of this
proposed collection of information, estimate of the burden of the proposed collection of information as follows:
tkelley on DSK3SPTVN1PROD with NOTICES

VerDate Sep<11>2014 17:31 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices 50641

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

Submission of Interstate Shellfish Dealer’s 3038 40 57 2,280 0.10 ............. 228
Certificate. (6 minutes) ..
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate that 40 respondents will Direct Comments To OMB: Written programs. ODP collaborates with NIH,
submit 2,280 Interstate Shellfish comments and/or suggestions regarding other Department of Health and Human
Dealer’s Certificates annually, for a total the item(s) contained in this notice, Services (DHHS) agencies, and other
burden of 228 hours (2,280 submissions especially regarding the estimated public and private partners to achieve
× 0.10 hours = 228 hours). This estimate public burden and associated response the Office’s mission and goals. One of
is based on our experience with this time, should be directed to the: Office our priorities is to promote the use of
information collection and the number of Management and Budget, Office of the best available methods in prevention
of certificates received in the past 3 Regulatory Affairs, OIRA_submission@ research and support the development
years, which has remained constant. omb.eop.gov or by fax to 202–395–6974, of better methods. One of our strategies
Dated: August 14, 2015. Attn: NIH Desk Officer. is to help NIH Scientific Review Officers
Leslie Kux, DATES: Comment Due Date: Comments (SROs) identify experts in prevention
regarding this information collection are science methods to include on their
Associate Commissioner for Policy.
best assured of having their full effect if review panels. This will strengthen the
[FR Doc. 2015–20562 Filed 8–19–15; 8:45 am]
received within 30-days of the date of panels and improve the quality of the
BILLING CODE 4164–01–P prevention research supported by NIH.
this publication.
FOR FURTHER INFORMATION CONTACT: To To identify experts in prevention
obtain a copy of the data collection science methods, we worked with our
DEPARTMENT OF HEALTH AND
plans and instruments, or request more contractor, IQ Solutions, Inc., to develop
HUMAN SERVICES
information on the proposed project, online software which will allow us to
National Institutes of Health contact: Paris Watson, Senior Advisor, collect researchers’ names, contact
NIH Office of Disease Prevention, 6100 information, and resumes, as well as to
Submission for OMB Review; 30-Day Executive Blvd., Room 2B03, Bethesda, have those researchers identify their
Comment Request; Identifying Experts MD 20892 or call (301) 496–1508 or level of expertise in a variety of
in Prevention Science Methods To email your request, including your prevention science methods and content
Include on NIH Review Panels (OD) address to prevention@mail.nih.gov. areas. The data collected with this
Formal requests for additional plans and software will be used to support a web-
SUMMARY: Under the provisions of instruments must be requested in based Electronic Directory that SROs
section 3507(a)(1)(D) of the Paperwork writing. can use to identify researchers with
Reduction Act of 1995, the National Proposed Collection: Identifying expertise in specific prevention science
Institutes of Health (NIH), Office of Experts in Prevention Science Methods methods and content areas for invitation
Disease Prevention (ODP) has submitted to Include on NIH Review Panels, to serve on one of the NIH review
to the Office of Management and Budget 0925—New, Office of Disease panels. If the initial rollout with the
(OMB) a request to review and approve Prevention (ODP), National Institutes of Center for Scientific Review (CSR) is
the information collection listed below. Health (NIH). successful, this system will also be
This proposed information collection Need and Use of Information shared with review staff in the other
was previously published in the Federal Collection: The Office of Disease Institutes and Centers at NIH, as well as
Register on April 7, 2015, page 18641 Prevention (ODP) is the lead Office at other DHHS agencies, to use in a similar
and allowed 60 days for public the National Institutes of Health (NIH) same way. Given our plans to create an
comment. No public comments were responsible for assessing, facilitating, automated system for reviewer
received. The purpose of this notice is and stimulating research in disease information collection, we are now
to allow an additional 30 days for public prevention and health promotion, and seeking OMB approval. This PRA
comment. The National Institutes of disseminating the results of this clearance request is for the deployment
Health may not conduct or sponsor, and research to improve public health. of this new online software and the
the respondent is not required to Prevention is preferable to treatment, collection of data.
respond to, an information collection and research on disease prevention is an OMB approval is requested for 3
that has been extended, revised, or important part of the NIH’s mission. The years. There are no costs to respondents
implemented on or after October 1, knowledge gained from this research other than their time. The total
1995, unless it displays a currently valid leads to stronger clinical practice, health estimated annualized burden hours are
OMB control number. policy, and community health 1,040.

ESTIMATED ANNUALIZED BURDEN HOURS
tkelley on DSK3SPTVN1PROD with NOTICES

Number of Average time
Number of Total annual
Type of respondents responses per per response
respondents burden hour
respondent (in hours)

Investigators ..................................................................................................... 3,120 1 20/60 1040

VerDate Sep<11>2014 17:31 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

Document Created: 2015-12-15 11:08:48
Document Modified: 2015-12-15 11:08:48

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		Submit either electronic or written comments on the collection of information by October 19, 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 50640

80 FR 50640 - Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealers Certificate

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 161 (August 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration