Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Draft Guidance for Industry; Availability, 58410-58411 [2017-26692]
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
Based on our experience with the
collection thus far, we retain the
currently approved burden estimate.
Accordingly, we estimate that we will
receive an average of five petitions and
five notifications annually over the next
3 years. Assuming an association of one
respondent to each petition or
notification, we estimate that five
respondents will each submit one
petition and five respondents will each
submit one notification. We estimate a
petition takes, on average, 100 hours to
develop and submit (Ref. 2). Therefore,
we estimate the total burden associated
with petitions will be 500 hours
annually (5 petitions × 100 hours per
petition).
The burden of a notification involves
collecting documentation that a food
ingredient does not pose an allergen
risk. Either we can make a
determination that the ingredient does
not cause an allergic response that poses
a risk to human health under a
premarket approval or notification
program under section 409 of the FD&C
Act, or the respondent submits scientific
evidence demonstrating that the
ingredient when manufactured as
described does not contain allergenic
protein. We estimate it takes a
respondent 20 hours to prepare and
submit a notification based on our
determination under a process under
section 409 of the FD&C Act that the
ingredient does not cause an allergic
response. We estimate respondents may
spend 100 hours to prepare a
notification submitting scientific
evidence (including the analytical
method used) that demonstrates that the
food ingredient (as derived by the
method specified in the notification,
where applicable) does not contain
allergenic protein. We have no data on
how many notifications would be based
on our determination that the ingredient
does not cause an allergic response or
based on scientific evidence that
demonstrates that the food ingredient
does not contain allergenic protein.
Therefore, we estimate that three of the
five notifications would be based on
scientific evidence, and two of the five
notifications would be based on our
determination. The average time per
notification is then estimated to be 68
hours (2 × 20 hours + 3 × 100 hours)/
5). Therefore, we estimate that the
burden associated with notifications
will be 340 hours annually (5
notifications × 68 hours per
notification), as reflected in table 2.
II. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
VerDate Sep<11>2014
20:03 Dec 11, 2017
Jkt 244001
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. RTI International, ‘‘Model to Estimate
Costs of Using Labeling as a Risk
Reduction Strategy for Consumer
Products Regulated by the Food and
Drug Administration, Final Report.’’
Prepared for Andrew Stivers, FDA/
CFSAN. Prepared by Muth, M., M. Ball,
M. Coglaiti, and S. Karns. RTI Project
Number 0211460.005. March 2011.
2. Gendel, S.M., ‘‘Food Allergen Petitions
and Notifications.’’ Memorandum to
File. August 8, 2011.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26690 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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
[Docket No. FDA–2017–D–6528]
Refusal of Inspection by a Foreign
Food Establishment or Foreign
Government; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled ‘‘Refusal
of Inspection by a Foreign Food
Establishment or Foreign Government.’’
This draft guidance, when finalized,
will provide information for foreign
food establishments subject to our
inspection, as well as foreign
governments, on when we may consider
that a foreign food establishment or a
government of a foreign country has
refused to permit an inspection by us as
provided in the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the draft guidance
by February 26, 2018 to ensure that the
Agency considers your comment on the
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–D–6528 for ‘‘Refusal of Inspection
by a Foreign Food Establishment or
Foreign Government.’’ 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 Dockets Management Staff
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
E:\FR\FM\12DEN1.SGM
12DEN1
ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
‘‘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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Compliance Policy Staff/Office of
Compliance, Center for Food Safety and
Applied Nutrition (HFS–605), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT:
Mischelle B. Ledet, Center for Food
Safety and Applied Nutrition (HFS–
605), Food and Drug Administration,
5001 Campus Dr., College Park, MD
20740, 240–701–5986, or Eric Nelson,
Center for Veterinary Medicine (HFV–
230), Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855,
240–402–5642, or Tyler Scandalios,
Office of Regulatory Affairs, Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857, 240–402–4552.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
20:03 Dec 11, 2017
Jkt 244001
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Refusal of Inspection by a Foreign
Food Establishment or Foreign
Government.’’ We are issuing the draft
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of the FDA on this topic. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternate
approach if it satisfies the requirements
of the applicable statutes and
regulations. The guidance is not subject
to Executive Order 12866.
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353), enacted
on January 4, 2011, amended the FD&C
Act to expand and enhance our ability
to ensure that imported food products
meet U.S. standards and are safe for
consumers. Among the FSMA changes
to the FD&C Act, we now must refuse
admission of a food into the United
States if it is from a foreign factory,
warehouse, or other establishment of
which the owner, operator, or agent in
charge, or the government of the foreign
country, refuses to permit entry of
United States inspectors or other
individuals duly designated by the
Secretary of Health and Human
Services, upon request, to inspect such
factory, warehouse, or other
establishment (section 807(b) of the
FD&C Act (21 U.S.C. 384c(b))). In
addition, the FD&C Act, at section
807(b), states that an owner, operator, or
agent in charge is considered to have
refused an inspection if the owner,
operator, or agent in charge does not
permit an inspection of a factory,
warehouse, or other establishment
during the 24-hour period after we
submit an inspection request, or after
such other time period, as agreed upon
by FDA and the foreign factory,
warehouse, or other establishment.
This draft guidance, when finalized,
will provide information for foreign
food establishments subject to our
inspection, as well as foreign
governments, on when we may consider
that a foreign food establishment or a
government of a foreign country has
refused to permit an inspection by us as
provided in section 807(b) of the FD&C
Act.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
58411
sentence to find the most current
version of the guidance.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26692 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4487]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Consumer and
Healthcare Professional Identification
of and Responses to Deceptive
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by January 11,
2018.
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—New and
title ‘‘Consumer and Healthcare
Professional Identification of and
Responses to Deceptive Prescription
Drug Promotion.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
DATES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58410-58411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26692]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6528]
Refusal of Inspection by a Foreign Food Establishment or Foreign
Government; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Refusal of
Inspection by a Foreign Food Establishment or Foreign Government.''
This draft guidance, when finalized, will provide information for
foreign food establishments subject to our inspection, as well as
foreign governments, on when we may consider that a foreign food
establishment or a government of a foreign country has refused to
permit an inspection by us as provided in the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the draft
guidance by February 26, 2018 to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-D-6528 for ``Refusal of Inspection by a Foreign Food
Establishment or Foreign Government.'' 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 Dockets Management Staff 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
[[Page 58411]]
``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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Compliance Policy Staff/Office of Compliance, Center for Food
Safety and Applied Nutrition (HFS-605), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740. Send two self-addressed
adhesive labels to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance.
FOR FURTHER INFORMATION CONTACT: Mischelle B. Ledet, Center for Food
Safety and Applied Nutrition (HFS-605), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-701-5986, or Eric Nelson,
Center for Veterinary Medicine (HFV-230), Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855, 240-402-5642, or Tyler
Scandalios, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 240-402-4552.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Refusal of Inspection by a Foreign Food Establishment or
Foreign Government.'' We are issuing the draft guidance consistent with
our good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent the current thinking of the
FDA on this topic. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternate approach
if it satisfies the requirements of the applicable statutes and
regulations. The guidance is not subject to Executive Order 12866.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
enacted on January 4, 2011, amended the FD&C Act to expand and enhance
our ability to ensure that imported food products meet U.S. standards
and are safe for consumers. Among the FSMA changes to the FD&C Act, we
now must refuse admission of a food into the United States if it is
from a foreign factory, warehouse, or other establishment of which the
owner, operator, or agent in charge, or the government of the foreign
country, refuses to permit entry of United States inspectors or other
individuals duly designated by the Secretary of Health and Human
Services, upon request, to inspect such factory, warehouse, or other
establishment (section 807(b) of the FD&C Act (21 U.S.C. 384c(b))). In
addition, the FD&C Act, at section 807(b), states that an owner,
operator, or agent in charge is considered to have refused an
inspection if the owner, operator, or agent in charge does not permit
an inspection of a factory, warehouse, or other establishment during
the 24-hour period after we submit an inspection request, or after such
other time period, as agreed upon by FDA and the foreign factory,
warehouse, or other establishment.
This draft guidance, when finalized, will provide information for
foreign food establishments subject to our inspection, as well as
foreign governments, on when we may consider that a foreign food
establishment or a government of a foreign country has refused to
permit an inspection by us as provided in section 807(b) of the FD&C
Act.
II. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26692 Filed 12-11-17; 8:45 am]
BILLING CODE 4164-01-P