82_FR_58647 82 FR 58410 - Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Draft Guidance for Industry; Availability

82 FR 58410 - Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 237 (December 12, 2017)

Page Range58410-58411
FR Document2017-26692

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Refusal of Inspection by a Foreign Food Establishment or Foreign Government.'' This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider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).

Federal Register, Volume 82 Issue 237 (Tuesday, December 12, 2017) 
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58410-58411]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26692]


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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Government; Draft Guidance for Industry; Availability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.

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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availability of a draft guidance for industry entitled ``Refusal of 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This draft guidance, when finalized, will provide information for 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DATES: Submit either electronic or written comments on the draft 
guidance by February 26, 2018 to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 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.thefederalregister.org/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

58410 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices Based on our experience with the for viewing by interested persons Electronic Submissions collection thus far, we retain the between 9 a.m. and 4 p.m., Monday Submit electronic comments in the currently approved burden estimate. through Friday; they are also available following way: Accordingly, we estimate that we will electronically at https:// • Federal eRulemaking Portal: receive an average of five petitions and www.regulations.gov. FDA has verified https://www.regulations.gov. Follow the five notifications annually over the next the website addresses, as of the date this instructions for submitting comments. 3 years. Assuming an association of one document publishes in the Federal Comments submitted electronically, respondent to each petition or Register, but websites are subject to including attachments, to https:// notification, we estimate that five change over time. www.regulations.gov will be posted to respondents will each submit one 1. RTI International, ‘‘Model to Estimate the docket unchanged. Because your petition and five respondents will each Costs of Using Labeling as a Risk comment will be made public, you are submit one notification. We estimate a Reduction Strategy for Consumer solely responsible for ensuring that your petition takes, on average, 100 hours to Products Regulated by the Food and comment does not include any develop and submit (Ref. 2). Therefore, Drug Administration, Final Report.’’ confidential information that you or a we estimate the total burden associated Prepared for Andrew Stivers, FDA/ CFSAN. Prepared by Muth, M., M. Ball, third party may not wish to be posted, with petitions will be 500 hours such as medical information, your or annually (5 petitions × 100 hours per M. Coglaiti, and S. Karns. RTI Project Number 0211460.005. March 2011. anyone else’s Social Security number, or petition). The burden of a notification involves 2. Gendel, S.M., ‘‘Food Allergen Petitions confidential business information, such collecting documentation that a food and Notifications.’’ Memorandum to as a manufacturing process. Please note File. August 8, 2011. that if you include your name, contact ingredient does not pose an allergen risk. Either we can make a Dated: December 6, 2017. information, or other information that determination that the ingredient does Leslie Kux, identifies you in the body of your not cause an allergic response that poses Associate Commissioner for Policy. comments, that information will be a risk to human health under a [FR Doc. 2017–26690 Filed 12–11–17; 8:45 am] posted on https://www.regulations.gov. premarket approval or notification • If you want to submit a comment BILLING CODE 4164–01–P program under section 409 of the FD&C with confidential information that you Act, or the respondent submits scientific do not wish to be made available to the evidence demonstrating that the DEPARTMENT OF HEALTH AND public, submit the comment as a ingredient when manufactured as HUMAN SERVICES written/paper submission and in the described does not contain allergenic manner detailed (see ‘‘Written/Paper protein. We estimate it takes a Food and Drug Administration Submissions’’ and ‘‘Instructions’’). respondent 20 hours to prepare and Written/Paper Submissions submit a notification based on our [Docket No. FDA–2017–D–6528] determination under a process under Submit written/paper submissions as section 409 of the FD&C Act that the Refusal of Inspection by a Foreign follows: ingredient does not cause an allergic Food Establishment or Foreign • Mail/Hand delivery/Courier (for response. We estimate respondents may Government; Draft Guidance for written/paper submissions): Dockets spend 100 hours to prepare a Industry; Availability Management Staff (HFA–305), Food and notification submitting scientific Drug Administration, 5630 Fishers evidence (including the analytical AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. method used) that demonstrates that the HHS. • For written/paper comments food ingredient (as derived by the ACTION: Notice of availability. submitted to the Dockets Management method specified in the notification, Staff, FDA will post your comment, as where applicable) does not contain SUMMARY: The Food and Drug well as any attachments, except for allergenic protein. We have no data on Administration (FDA or we) is information submitted, marked and how many notifications would be based announcing the availability of a draft identified, as confidential, if submitted on our determination that the ingredient guidance for industry entitled ‘‘Refusal as detailed in ‘‘Instructions.’’ does not cause an allergic response or of Inspection by a Foreign Food Instructions: All submissions received based on scientific evidence that Establishment or Foreign Government.’’ must include the Docket No. FDA– demonstrates that the food ingredient This draft guidance, when finalized, 2017–D–6528 for ‘‘Refusal of Inspection does not contain allergenic protein. will provide information for foreign by a Foreign Food Establishment or Therefore, we estimate that three of the food establishments subject to our Foreign Government.’’ Received five notifications would be based on inspection, as well as foreign comments will be placed in the docket scientific evidence, and two of the five governments, on when we may consider and, except for those submitted as notifications would be based on our that a foreign food establishment or a ‘‘Confidential Submissions,’’ publicly determination. The average time per government of a foreign country has viewable at https://www.regulations.gov notification is then estimated to be 68 refused to permit an inspection by us as or at the Dockets Management Staff hours (2 × 20 hours + 3 × 100 hours)/ provided in the Federal Food, Drug, and between 9 a.m. and 4 p.m., Monday 5). Therefore, we estimate that the Cosmetic Act (FD&C Act). through Friday. burden associated with notifications • Confidential Submissions—To DATES: Submit either electronic or submit a comment with confidential will be 340 hours annually (5 ethrower on DSK3G9T082PROD with NOTICES written comments on the draft guidance notifications × 68 hours per information that you do not wish to be by February 26, 2018 to ensure that the made publicly available, submit your notification), as reflected in table 2. Agency considers your comment on the comments only as a written/paper II. References draft guidance before it begins work on submission. You should submit two The following references are on the final version of the guidance. copies total. One copy will include the display in the Dockets Management ADDRESSES: You may submit comments information you claim to be confidential Staff (see ADDRESSES) and are available on any guidance at any time as follows: with a heading or cover note that states VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58411 ‘‘THIS DOCUMENT CONTAINS I. Background sentence to find the most current CONFIDENTIAL INFORMATION.’’ The We are announcing the availability of version of the guidance. Agency will review this copy, including a draft guidance for industry entitled Dated: December 6, 2017. the claimed confidential information, in ‘‘Refusal of Inspection by a Foreign Leslie Kux, its consideration of comments. The Food Establishment or Foreign Associate Commissioner for Policy. second copy, which will have the Government.’’ We are issuing the draft [FR Doc. 2017–26692 Filed 12–11–17; 8:45 am] claimed confidential information guidance consistent with our good redacted/blacked out, will be available BILLING CODE 4164–01–P guidance practices regulation (21 CFR for public viewing and posted on 10.115). The draft guidance, when https://www.regulations.gov. Submit finalized, will represent the current DEPARTMENT OF HEALTH AND both copies to the Dockets Management thinking of the FDA on this topic. It HUMAN SERVICES Staff. If you do not wish your name and does not establish any rights for any contact information to be made publicly person and is not binding on FDA or the Food and Drug Administration available, you can provide this public. You can use an alternate information on the cover sheet and not approach if it satisfies the requirements [Docket No. FDA–2016–N–4487] in the body of your comments and you of the applicable statutes and must identify this information as regulations. The guidance is not subject Agency Information Collection ‘‘confidential.’’ Any information marked to Executive Order 12866. Activities; Submission for Office of as ‘‘confidential’’ will not be disclosed The FDA Food Safety Modernization Management and Budget Review; except in accordance with 21 CFR 10.20 Act (FSMA) (Pub. L. 111–353), enacted Comment Request; Consumer and and other applicable disclosure law. For on January 4, 2011, amended the FD&C Healthcare Professional Identification more information about FDA’s posting Act to expand and enhance our ability of and Responses to Deceptive of comments to public dockets, see 80 to ensure that imported food products Prescription Drug Promotion FR 56469, September 18, 2015, or access meet U.S. standards and are safe for the information at: https://www.gpo.gov/ consumers. Among the FSMA changes AGENCY: Food and Drug Administration, fdsys/pkg/FR-2015-09-18/pdf/2015- to the FD&C Act, we now must refuse HHS. 23389.pdf. admission of a food into the United ACTION: Notice. Docket: For access to the docket to States if it is from a foreign factory, read background documents or the warehouse, or other establishment of SUMMARY: The Food and Drug electronic and written/paper comments which the owner, operator, or agent in Administration (FDA) is announcing received, go to https:// charge, or the government of the foreign that a proposed collection of www.regulations.gov and insert the country, refuses to permit entry of information has been submitted to the docket number, found in brackets in the United States inspectors or other Office of Management and Budget heading of this document, into the individuals duly designated by the (OMB) for review and clearance under ‘‘Search’’ box and follow the prompts Secretary of Health and Human the Paperwork Reduction Act of 1995 and/or go to the Dockets Management Services, upon request, to inspect such (PRA). Staff, 5630 Fishers Lane, Rm. 1061, factory, warehouse, or other DATES: Fax written comments on the Rockville, MD 20852. establishment (section 807(b) of the collection of information by January 11, You may submit comments on any FD&C Act (21 U.S.C. 384c(b))). In 2018. guidance at any time (see 21 CFR addition, the FD&C Act, at section ADDRESSES: To ensure that comments on 10.115(g)(5)). Submit written requests for single 807(b), states that an owner, operator, or the information collection are received, copies of the draft guidance to the agent in charge is considered to have OMB recommends that written Compliance Policy Staff/Office of refused an inspection if the owner, comments be faxed to the Office of Compliance, Center for Food Safety and operator, or agent in charge does not Information and Regulatory Affairs, Applied Nutrition (HFS–605), Food and permit an inspection of a factory, OMB, Attn: FDA Desk Officer, Fax: 202– Drug Administration, 5001 Campus Dr., warehouse, or other establishment 395–7285, or emailed to oira_ College Park, MD 20740. Send two self- during the 24-hour period after we submission@omb.eop.gov. All addressed adhesive labels to assist that submit an inspection request, or after comments should be identified with the office in processing your request. See such other time period, as agreed upon OMB control number 0910—New and the SUPPLEMENTARY INFORMATION section by FDA and the foreign factory, title ‘‘Consumer and Healthcare for electronic access to the draft warehouse, or other establishment. Professional Identification of and guidance. This draft guidance, when finalized, Responses to Deceptive Prescription will provide information for foreign Drug Promotion.’’ Also include the FDA FOR FURTHER INFORMATION CONTACT: food establishments subject to our docket number found in brackets in the Mischelle B. Ledet, Center for Food inspection, as well as foreign heading of this document. Safety and Applied Nutrition (HFS– governments, on when we may consider 605), Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: Ila that a foreign food establishment or a 5001 Campus Dr., College Park, MD S. Mizrachi, Office of Operations, Food government of a foreign country has 20740, 240–701–5986, or Eric Nelson, and Drug Administration, Three White refused to permit an inspection by us as Center for Veterinary Medicine (HFV– Flint North, 10A–12M, 11601 provided in section 807(b) of the FD&C 230), Food and Drug Administration, Landsdown St., North Bethesda, MD Act. ethrower on DSK3G9T082PROD with NOTICES 7519 Standish Pl., Rockville, MD 20855, 20852, 301–796–7726, PRAStaff@ 240–402–5642, or Tyler Scandalios, II. Electronic Access fda.hhs.gov. Office of Regulatory Affairs, Food and Persons with access to the internet SUPPLEMENTARY INFORMATION: In Drug Administration, 12420 Parklawn may obtain the draft guidance at either compliance with 44 U.S.C. 3507, FDA Dr., Element Bldg., Rockville, MD https://www.fda.gov/FoodGuidances or has submitted the following proposed 20857, 240–402–4552. https://www.regulations.gov. Use the collection of information to OMB for SUPPLEMENTARY INFORMATION: FDA website listed in the previous review and clearance. VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1


Document Created: 2018-10-25 10:49:42
Document Modified: 2018-10-25 10:49:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit 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.
ContactMischelle 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.
FR Citation82 FR 58410 
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