Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 27140-27143 [2016-10559]
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27140
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0065]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration of
Food Facilities Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the 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 Agency’s
regulations that require registration for
domestic and foreign facilities that
manufacture, process, pack, or hold
food for human or animal consumption
in the United States.
DATES: Submit either electronic or
written comments on the collection of
information by July 5, 2016.
ADDRESSES: You may submit comments
as follows:
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
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• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0065 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Registration of Food Facilities Under the
Public Health Security and Bioterrorism
Preparedness and Response Act of
2002.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
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accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
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,
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
when appropriate, and other forms of
information technology.
Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.230 to
1.235 OMB Control Number 0910–
0502—Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 415 to the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 350d), which
requires domestic and foreign facilities
that manufacture, process, pack, or hold
food for human or animal consumption
in the United States to register with
FDA. Sections 1.230 to 1.235 of FDA’s
regulations (21 CFR 1.230 to 1.235) set
forth the procedures for registration of
food facilities. Information provided to
FDA under these regulations helps the
agency to notify quickly the facilities
that might be affected by a deliberate or
accidental contamination of the food
supply. In addition, data collected
through registration is used to support
FDA enforcement activities and to
screen imported food shipments.
Advance notice of imported food allows
FDA, with the support of the Bureau of
Customs and Border Protection, to target
import inspections more effectively and
help protect the nation’s food supply
against terrorist acts and other public
health emergencies. If a facility is not
registered or the registration for a
facility is not updated when necessary,
FDA may not be able to contact the
facility and may not be able to target
import inspections effectively in case of
a known or potential threat to the food
supply or other food-related emergency,
putting consumers at risk of consuming
hazardous food products that could
cause serious adverse health
consequences or death.
FDA’s regulations require that each
facility that manufactures, processes,
packs, or holds food for human or
animal consumption in the United
States register with FDA using Form
FDA 3537 (§ 1.231), unless exempt
under 21 CFR 1.226 from the
requirement to register. The term ‘‘Form
FDA 3537’’ refers to both the paper
version of the form and the electronic
system known as the Food Facility
Registration Module, which is available
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at https://www.access.fda.gov. Domestic
facilities are required to register whether
or not food from the facility enters
interstate commerce. Foreign facilities
that manufacture/process, pack, or hold
food also are required to register unless
food from that facility undergoes further
processing (including packaging) by
another foreign facility outside the
United States. However, if the further
manufacturing/processing conducted by
the subsequent facility consists of
adding labeling or any similar activity of
a de minimis nature, the former facility
is required to register.
Information FDA requires on the
registration form includes the name and
full address of the facility; emergency
contact information; all trade names the
facility uses; applicable food product
categories; and a certification statement
that includes the name of the individual
authorized to submit the registration
form. Additionally, facilities are
encouraged to submit their preferred
mailing address; type of activity
conducted at the facility; type of storage,
if the facility is primarily a holding
facility; and approximate dates of
operation if the facility’s business is
seasonal.
In addition to registering, a facility is
required to submit timely updates
within 60 days of a change to any
required information on its registration
form, using Form FDA 3537 (§ 1.234),
and to cancel its registration when the
facility ceases to operate or is sold to
new owners or ceases to manufacture/
process, pack, or hold food for
consumption in the United States, using
Form FDA 3537a (§ 1.235).
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) amended
section 415 of the FD&C Act in relevant
part to require registrants for food
facilities to submit additional
registration information to FDA, and to
require facilities required to register
with FDA to renew such registrations
biennially. Section 415(a)(2) of the
FD&C Act, as amended by FSMA, also
provides that, when determined
necessary by FDA ‘‘through guidance,’’
a food facility is required to submit to
FDA information about the general food
category of a food manufactured,
processed, packed or held at such
facility, as determined appropriate by
FDA, including by guidance. The
modified food facility registration forms
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includes the following mandatory fields:
(1) The email address for the contact
person of a domestic facility and the
email address of the United States agent
for a foreign facility; (2) an assurance
that FDA will be permitted to inspect
the facility; and (3) specific food
categories as identified in the guidance
document entitled, ‘‘Guidance for
Industry: Necessity of the Use of Food
Product Categories in Food Facility
Registrations and Updates to Food
Product Categories’’ (section 415(a)(2) of
the FD&C Act 21 U.S.C. 350d(a)(2)).
Food Facility Registration, in
conjunction with advance notice of
imported food, helps FDA act quickly in
responding to a threatened or actual
bioterrorist attack on the U.S. food
supply or to other food-related
emergencies. Food Facility Registration
provides FDA with information about
facilities that manufacture/process,
pack, or hold food for consumption in
the United States. In the event of an
outbreak of foodborne illness, such
information helps FDA and other
authorities determine the source and
cause of the event. In addition, the
registration information enables FDA to
notify more quickly the facilities that
might be affected by the outbreak. See
Interim Final Rule entitled,
‘‘Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002’’ (68 FR 58894, at
58895; October 10, 2003).
Implementation of the FSMA
requirements described previously
helps enable FDA to quickly identify
and remove from commerce an article of
food for which there is a reasonable
probability that the use of, or exposure
to, such article of food will cause
serious adverse health consequences or
death to humans or animals. FDA uses
the information collected under these
provisions to help ensure that such food
products are quickly and efficiently
removed from the market.
Description of Respondents:
Respondents to this collection of
information are owners, operators, or
agents in charge of domestic or foreign
facilities that manufacture, process,
pack, or hold food for human or animal
consumption in the United States.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section and/or section of FD&C
Act
FDA form
number
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
New Facilities
Domestic
FDA 3537 2
§§ 1.230 to 1.233 and section 415 of the
FD&C Act.
11,080
1
11,080
2.7 ..................
29,916
Foreign
§§ 1.230 to 1.233 and section 415 of the
FD&C Act.
FDA 3537
19,900
1
19,900
8.9 ..................
177,110
New Facility Registration Subtotal ...
........................
........................
........................
........................
........................
207,026
Previously Registered Facilities
Updates under § 1.234 and section 415
of the FD&C Act.
Cancellations under § 1.235 ....................
Biennial renewal of registration required
by section 415 of the FD&C Act.
FDA 3537
118,530
1
118,530
1.2 ..................
142,236
FDA 3537a
FDA 3537
6,390
104,786
1
1
6,390
104,786
1 .....................
0.50 (30 mins.)
6,390
52,393
Updates, Cancellations, or Biennial
Renewals Subtotal.
........................
........................
........................
........................
........................
201,019
Total Hours Annually .................
........................
........................
........................
........................
........................
408,045
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
term ‘‘Form FDA 3537’’ refers to both the paper version of the form and the electronic system known as the Food Facility Registration
Module, which is available at https://www.access.fda.gov.
mstockstill on DSK3G9T082PROD with NOTICES
2 The
This estimate is based on FDA’s
experience and the average number of
new facility registrations, updates and
cancellations received in the past 3
years. Based on this experience, we
estimate the annual number of new
domestic facility registrations will be
11,080. We estimate that listing the
information required by the
Bioterrorism Act and presenting it in a
format that will meet the Agency’s
registration regulations will require a
burden of approximately 2.5 hours per
average domestic facility registration.
We estimate that the FSMA-required
additional information for new facility
registrations will require an additional
12 minutes (0.2 hour) per response for
domestic facilities. The average
domestic facility burden hour estimate
of 2.7 hours takes into account that
some respondents completing the
registration may not have readily
available Internet access. Thus, the total
annual burden for new domestic facility
registrations is calculated to be 29,916
hours (11,080 × 2.7 hours).
Based on FDA’s experience, we
estimate the annual number of new
foreign facility registrations will be
19,900. We estimate that listing the
information required by the
Bioterrorism Act and presenting it in a
format that will meet the Agency’s
registration regulations will require a
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burden of approximately 8.5 hours per
average foreign facility registration. We
estimate that the FSMA-required
additional information for new facility
registrations will require an additional
24 minutes (0.4 hour) per response for
foreign facilities. The average foreign
facility burden hour estimate of 8.9
hours includes an estimate of the
additional burden on a foreign facility to
obtain a U.S. agent, and takes into
account that for some foreign facilities
the respondent completing the
registration may not be fluent in English
and/or not have readily available
Internet access. Thus, the total annual
burden for new foreign facility
registrations is calculated to be 177,110
hours (19,900 × 8.9 hours).
Based on FDA’s experience, we
estimate that the average annual number
of updates to facility registrations will
remain unchanged at 118,530 updates
annually over the next 3 years. We also
estimate that updating a registration
will, on average, require a burden of
approximately 1 hour, taking into
account fluency in English and Internet
access. We estimate that the FSMArequired additional information for
updates will require an additional 12
minutes (0.2 hour) per response. Thus,
the total annual burden of submitting
updates to facility registrations is
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calculated to be 142,236 hours (118,530
× 1.2 hours).
Based on FDA’s experience, we
estimate that the average annual number
of cancellations of facility registrations
will remain unchanged at 6,390
cancellations annually over the next 3
years. We also estimate that cancelling
a registration will, on average, require a
burden of approximately 1 hour, taking
into account fluency in English and
Internet access. FSMA did not change
the required information for
cancellations. Thus, the total annual
burden for cancelling registrations is
estimated to be 6,390 hours.
We estimate that the new biennial
registration required by FSMA, which
will require the submission of certain
new data elements and the verification
and possible updating of other
information rather than re-entering all
information, will require 30 minutes
(0.5 hour) per response, including time
for the new FSMA-required information.
We estimate that, on an annualized
basis, the number of biennial
registrations submitted over the next 3
years will be 104,786. This estimate is
based on the number of currently
registered firms (209,573) divided by
two. Thus, the total annual burden for
biennial registration is calculated to be
52,393 hours (104,786 × 0.5 hours).
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Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices
Dated: May 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Period of Performance: July 1, 2016, to
June 30, 2017.
Intended Recipient of the Award:
National Alliance of State and
Territorial AIDS Directors.
Amount of Non-Competitive Award:
$900,000.
[FR Doc. 2016–10559 Filed 5–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
CFDA Number: 93.145.
Health Resources and Services
Administration
Ryan White HIV/AIDS Program
Resource and Technical Assistance
Center for HIV Prevention and Care for
Black MSM
Health Resources and Services
Administration, HHS.
ACTION: Notice of deviation from
competition requirements for Ryan
White HIV/AIDS Program (RWHAP)
Resource and Technical Assistance
Center for HIV Prevention and Care for
Black men who have sex with men
(MSM) (Grant#U69HA27173).
AGENCY:
The HIV/AIDS Bureau (HAB)
is requesting a deviation from the
competition requirements in order to
provide a 1 year extension with funds
to the Resource and Technical
Assistance Center for HIV Prevention
and Care for Black MSM cooperative
agreement recipient, the National
Alliance of State and Territorial AIDS
Directors. The purpose of the program is
to develop a Resource and Technical
Assistance Center for HIV prevention
and care of models and interventions
that increase the capacity, quality, and
effectiveness of HIV/AIDS service
providers to screen, diagnose, link, and
retain, the adult and young Black MSM
community in HIV clinical care. The 2year project period ends June 30, 2016.
The extension through June 30, 2017,
for this project provides necessary
funding and time to complete
previously approved project activities,
an orderly phase out, and transition to
the next stage of evaluation for the
models of HIV clinical care and best
practices needed for HIV viral
suppression. The next stage of planning
by HAB is to use the models, tools, and
best practices developed for improved
health outcomes by this recipient for
fiscal year 2017 competitive funding
under the HAB Special Projects of
National Significance Program.
FOR FURTHER INFORMATION CONTACT:
Antigone Dempsey, Director, Division of
Policy and Data, HRSA/HAB/DPD, 5600
Fishers Lane, Rockville, MD 20857,
email: adempsey@hrsa.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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18:06 May 04, 2016
Jkt 238001
Authority: Sections 2606, 2654, 2671, and
2692 of Title XXVI of the Public Health
Service Act, as amended by the Ryan White
HIV/AIDS Treatment Extension Act of 2009
(Pub. L. 111–87)
Justification: The National Alliance of
State and Territorial AIDS Directors has
been very successful at collecting,
developing, and analyzing clinical
models of care and best practices for
HIV care and treatment. Additional time
is needed to complete analyses and
disseminate them across the country to
grant recipients, health centers, and HIV
stakeholder communities. This funding
reflects the amount needed to complete
the final phase of program activities,
which is the dissemination of models
and best practices for HIV treatment and
care through Ryan White Part C and D
grant recipients, AIDS Education and
Training Centers, and HRSA Bureau of
Primary Health Care Health Centers to
improve engagement of and retention in
care for young Black MSM, one of the
highest risk populations identified in
the National HIV/AIDS Strategy for HIV
transmission. The aim and purpose of
dissemination of these interventions is
to increase the capacity, quality, and
effectiveness of HIV/AIDS service
providers to screen, diagnose, link, and
retain the adult and young Black MSM
community in HIV clinical care.
Dated: April 29, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016–10533 Filed 5–4–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Recruitment of Sites for Assignment of
Corps Personnel Obligated Under the
National Health Service Corps
Scholarship Program
Health Resources and Services
Administration (HRSA), HHS.
ACTION: General notice.
AGENCY:
HRSA announces that the
listing of entities, and associated Health
Professional Shortage Area (HPSA)
scores, that will receive priority for the
SUMMARY:
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27143
assignment of National Health Service
Corps (NHSC) scholarship recipients
available for service during the period
October 1, 2016, through September 30,
2017, is posted on the NHSC Jobs Center
Web site at https://nhscjobs.hrsa.gov.
The NHSC Jobs Center includes sites
that are approved for performance of
service by NHSC scholars; however,
note that entities on this list may or may
not have current job vacancies.
Eligible HPSAs and Entities
To be eligible to receive assignment of
Corps members, entities must: (1) Have
a current HPSA status of ‘‘designated’’
by the Division of Policy and Shortage
Designation, Bureau of Health
Workforce, HRSA, as of January 1, 2016,
for placements October 1, 2016, through
December 31, 2016, or as of January 1,
2017, for placements January 1, 2017,
through September 30, 2017; (2) not
deny requested health care services or
discriminate in the provision of services
to an individual because the individual
is unable to pay for the services, because
payment for the services would be made
under Medicare, Medicaid, or the
Children’s Health Insurance Program
(CHIP), or based upon the individual’s
race, color, sex, national origin,
disability, religion, age, or sexual
orientation; (3) enter into an agreement
with the state agency that administers
Medicaid and CHIP, accept assignment
under Medicare, see all patients
regardless of their ability to pay and
post such policy, and use and post a
discounted fee plan; and (4) be
determined by the Secretary to have (a)
a need and demand for health
manpower in the area; (b) appropriately
and efficiently used Corps members
assigned to the entity in the past; (c)
general community support for the
assignment of Corps members; (d) made
unsuccessful efforts to recruit health
professionals; (e) a reasonable prospect
for sound fiscal management by the
entity with respect to Corps members
assigned there; and (f) demonstrated a
willingness to support and facilitate
mentorship, professional development,
and training opportunities for Corps
members.
Priority in approving applications for
assignment of Corps members goes to
sites that (1) provide primary medical
care, mental health, and/or oral health
services that matches the discipline to a
primary medical care, mental health, or
dental HPSA of greatest shortage,
respectively; (2) are part of a system of
care that provides a continuum of
services, including comprehensive
primary health care and appropriate
referrals (e.g., ancillary, inpatient, and
specialty referrals) or arrangements for
E:\FR\FM\05MYN1.SGM
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Agencies
[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Notices]
[Pages 27140-27143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10559]
[[Page 27140]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0065]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Food Facilities Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
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 the 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 Agency's regulations that require registration for
domestic and foreign facilities that manufacture, process, pack, or
hold food for human or animal consumption in the United States.
DATES: Submit either electronic or written comments on the collection
of information by July 5, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0065 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Food Facilities
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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: 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, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites 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,
[[Page 27141]]
when appropriate, and other forms of information technology.
Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.230 to
1.235 OMB Control Number 0910-0502--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) added section 415 to the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d),
which requires domestic and foreign facilities that manufacture,
process, pack, or hold food for human or animal consumption in the
United States to register with FDA. Sections 1.230 to 1.235 of FDA's
regulations (21 CFR 1.230 to 1.235) set forth the procedures for
registration of food facilities. Information provided to FDA under
these regulations helps the agency to notify quickly the facilities
that might be affected by a deliberate or accidental contamination of
the food supply. In addition, data collected through registration is
used to support FDA enforcement activities and to screen imported food
shipments. Advance notice of imported food allows FDA, with the support
of the Bureau of Customs and Border Protection, to target import
inspections more effectively and help protect the nation's food supply
against terrorist acts and other public health emergencies. If a
facility is not registered or the registration for a facility is not
updated when necessary, FDA may not be able to contact the facility and
may not be able to target import inspections effectively in case of a
known or potential threat to the food supply or other food-related
emergency, putting consumers at risk of consuming hazardous food
products that could cause serious adverse health consequences or death.
FDA's regulations require that each facility that manufactures,
processes, packs, or holds food for human or animal consumption in the
United States register with FDA using Form FDA 3537 (Sec. 1.231),
unless exempt under 21 CFR 1.226 from the requirement to register. The
term ``Form FDA 3537'' refers to both the paper version of the form and
the electronic system known as the Food Facility Registration Module,
which is available at https://www.access.fda.gov. Domestic facilities
are required to register whether or not food from the facility enters
interstate commerce. Foreign facilities that manufacture/process, pack,
or hold food also are required to register unless food from that
facility undergoes further processing (including packaging) by another
foreign facility outside the United States. However, if the further
manufacturing/processing conducted by the subsequent facility consists
of adding labeling or any similar activity of a de minimis nature, the
former facility is required to register.
Information FDA requires on the registration form includes the name
and full address of the facility; emergency contact information; all
trade names the facility uses; applicable food product categories; and
a certification statement that includes the name of the individual
authorized to submit the registration form. Additionally, facilities
are encouraged to submit their preferred mailing address; type of
activity conducted at the facility; type of storage, if the facility is
primarily a holding facility; and approximate dates of operation if the
facility's business is seasonal.
In addition to registering, a facility is required to submit timely
updates within 60 days of a change to any required information on its
registration form, using Form FDA 3537 (Sec. 1.234), and to cancel its
registration when the facility ceases to operate or is sold to new
owners or ceases to manufacture/process, pack, or hold food for
consumption in the United States, using Form FDA 3537a (Sec. 1.235).
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
amended section 415 of the FD&C Act in relevant part to require
registrants for food facilities to submit additional registration
information to FDA, and to require facilities required to register with
FDA to renew such registrations biennially. Section 415(a)(2) of the
FD&C Act, as amended by FSMA, also provides that, when determined
necessary by FDA ``through guidance,'' a food facility is required to
submit to FDA information about the general food category of a food
manufactured, processed, packed or held at such facility, as determined
appropriate by FDA, including by guidance. The modified food facility
registration forms includes the following mandatory fields: (1) The
email address for the contact person of a domestic facility and the
email address of the United States agent for a foreign facility; (2) an
assurance that FDA will be permitted to inspect the facility; and (3)
specific food categories as identified in the guidance document
entitled, ``Guidance for Industry: Necessity of the Use of Food Product
Categories in Food Facility Registrations and Updates to Food Product
Categories'' (section 415(a)(2) of the FD&C Act 21 U.S.C. 350d(a)(2)).
Food Facility Registration, in conjunction with advance notice of
imported food, helps FDA act quickly in responding to a threatened or
actual bioterrorist attack on the U.S. food supply or to other food-
related emergencies. Food Facility Registration provides FDA with
information about facilities that manufacture/process, pack, or hold
food for consumption in the United States. In the event of an outbreak
of foodborne illness, such information helps FDA and other authorities
determine the source and cause of the event. In addition, the
registration information enables FDA to notify more quickly the
facilities that might be affected by the outbreak. See Interim Final
Rule entitled, ``Registration of Food Facilities Under the Public
Health Security and Bioterrorism Preparedness and Response Act of
2002'' (68 FR 58894, at 58895; October 10, 2003).
Implementation of the FSMA requirements described previously helps
enable FDA to quickly identify and remove from commerce an article of
food for which there is a reasonable probability that the use of, or
exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals. FDA uses the information
collected under these provisions to help ensure that such food products
are quickly and efficiently removed from the market.
Description of Respondents: Respondents to this collection of
information are owners, operators, or agents in charge of domestic or
foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States.
FDA estimates the burden of this collection of information as
follows:
[[Page 27142]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section and/or section of FD&C FDA form Number of responses per Total annual Average burden per response Total hours
Act number respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 1.230 to 1.233 and section FDA 3537 \2\ 11,080 1 11,080 2.7........................... 29,916
415 of the FD&C Act.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 1.230 to 1.233 and section FDA 3537 19,900 1 19,900 8.9........................... 177,110
415 of the FD&C Act.
---------------------------------------------------------------------------------------------------------------
New Facility Registration Subtotal.. .............. .............. .............. .............. .............................. 207,026
--------------------------------------------------------------------------------------------------------------------------------------------------------
Previously Registered Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updates under Sec. 1.234 and section FDA 3537 118,530 1 118,530 1.2........................... 142,236
415 of the FD&C Act.
Cancellations under Sec. 1.235........ FDA 3537a 6,390 1 6,390 1............................. 6,390
Biennial renewal of registration FDA 3537 104,786 1 104,786 0.50 (30 mins.)............... 52,393
required by section 415 of the FD&C Act.
---------------------------------------------------------------------------------------------------------------
Updates, Cancellations, or Biennial .............. .............. .............. .............. .............................. 201,019
Renewals Subtotal.
---------------------------------------------------------------------------------------------------------------
Total Hours Annually............ .............. .............. .............. .............. .............................. 408,045
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3537'' refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module,
which is available at https://www.access.fda.gov.
This estimate is based on FDA's experience and the average number
of new facility registrations, updates and cancellations received in
the past 3 years. Based on this experience, we estimate the annual
number of new domestic facility registrations will be 11,080. We
estimate that listing the information required by the Bioterrorism Act
and presenting it in a format that will meet the Agency's registration
regulations will require a burden of approximately 2.5 hours per
average domestic facility registration. We estimate that the FSMA-
required additional information for new facility registrations will
require an additional 12 minutes (0.2 hour) per response for domestic
facilities. The average domestic facility burden hour estimate of 2.7
hours takes into account that some respondents completing the
registration may not have readily available Internet access. Thus, the
total annual burden for new domestic facility registrations is
calculated to be 29,916 hours (11,080 x 2.7 hours).
Based on FDA's experience, we estimate the annual number of new
foreign facility registrations will be 19,900. We estimate that listing
the information required by the Bioterrorism Act and presenting it in a
format that will meet the Agency's registration regulations will
require a burden of approximately 8.5 hours per average foreign
facility registration. We estimate that the FSMA-required additional
information for new facility registrations will require an additional
24 minutes (0.4 hour) per response for foreign facilities. The average
foreign facility burden hour estimate of 8.9 hours includes an estimate
of the additional burden on a foreign facility to obtain a U.S. agent,
and takes into account that for some foreign facilities the respondent
completing the registration may not be fluent in English and/or not
have readily available Internet access. Thus, the total annual burden
for new foreign facility registrations is calculated to be 177,110
hours (19,900 x 8.9 hours).
Based on FDA's experience, we estimate that the average annual
number of updates to facility registrations will remain unchanged at
118,530 updates annually over the next 3 years. We also estimate that
updating a registration will, on average, require a burden of
approximately 1 hour, taking into account fluency in English and
Internet access. We estimate that the FSMA-required additional
information for updates will require an additional 12 minutes (0.2
hour) per response. Thus, the total annual burden of submitting updates
to facility registrations is calculated to be 142,236 hours (118,530 x
1.2 hours).
Based on FDA's experience, we estimate that the average annual
number of cancellations of facility registrations will remain unchanged
at 6,390 cancellations annually over the next 3 years. We also estimate
that cancelling a registration will, on average, require a burden of
approximately 1 hour, taking into account fluency in English and
Internet access. FSMA did not change the required information for
cancellations. Thus, the total annual burden for cancelling
registrations is estimated to be 6,390 hours.
We estimate that the new biennial registration required by FSMA,
which will require the submission of certain new data elements and the
verification and possible updating of other information rather than re-
entering all information, will require 30 minutes (0.5 hour) per
response, including time for the new FSMA-required information. We
estimate that, on an annualized basis, the number of biennial
registrations submitted over the next 3 years will be 104,786. This
estimate is based on the number of currently registered firms (209,573)
divided by two. Thus, the total annual burden for biennial registration
is calculated to be 52,393 hours (104,786 x 0.5 hours).
[[Page 27143]]
Dated: May 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10559 Filed 5-4-16; 8:45 am]
BILLING CODE 4164-01-P