Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China, 57282-57284 [2017-26042]

Download as PDF 57282 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices https://www.fda.gov/downloads/ MedicalDevices/DeviceRegulation andGuidance/GuidanceDocuments/ ucm077295.pdf. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency’s standards program is available at https://www.fda.gov/ MedicalDevices/DeviceRegulation andGuidance/Standards/default.htm. II. Listing of New Entries, Recognition List Number: 048 In table 1, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 048. FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. TABLE 1—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Title of standard 1 Recognition No. Reference No. and date A. Radiology 12–307 ................. Radiation therapy readiness check ................................................................. AAMI RT2:2017. B. Software/Informatics 13–98 ................... 13–99 ................... 13–100 ................. 13–101 ................. 13–102 ................. 13–103 ................. 1 All Information technology—IS0 7-bit coded character set for information interchange. Information technology—Automatic identification and data capture techniques—Unique identification—Part 2: Registration procedures. Information technology—Automatic identification and data capture techniques—Unique identification—Part 4: Individual products and product packages. Information technology—Automatic identification and data capture techniques—Unique identification—Part 6: Groupings. Application of risk management for IT-networks incorporating medical devices—Part 2–8: Application guidance—Guidance on standards for establishing the security capabilities identified in IEC TR 80001–2–2. Application of risk management for IT-networks incorporating medical devices—Part 2–9: Application guidance—Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001–2–2 security capabilities. ISO/IEC 15459–2 Third edition 2015–03–01. ISO/IEC 15459–4 Third edition 2014–11–15 Corrected version 2016–09–01. ISO/IEC 15459–6 Second edition 2014–11– 15 Corrected version 2016–09–01. IEC TR 80001–2–8 Edition 1.0 2016–05. IEC TR 80001–2–9 Edition 1.0 2017–01. standard titles in this table conform to the style requirements of the respective organizations. III. List of Recognized Standards FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. FDA will be incorporating the modifications described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will be announcing additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary. sradovich on DSK3GMQ082PROD with NOTICES ISO/IEC 646 Third edition 1991–12–15. following information: (1) Title of the standard, (2) any reference number and date, (3) name and electronic or mailing address of the requestor, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. Dated: November 29, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26043 Filed 12–1–17; 8:45 am] 18:22 Dec 01, 2017 Jkt 244001 Food and Drug Administration [Docket No. FDA–2014–N–0192] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China BILLING CODE 4164–01–P AGENCY: IV. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations should contain, at a minimum, the VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 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. SUMMARY: Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices Fax written comments on the collection of information by January 3, 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 0910–0839. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, 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. sradovich on DSK3GMQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: Establishing and Maintaining Lists of U.S. Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products to China—21 U.S.C. 371 OMB Control Number 0910–0839—Extension The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food product that the manufacturer/processor of the food product is in compliance with applicable country of origin regulatory requirements. Some foreign governments establish additional requirements with which exporters are required to comply. In August 2011, China’s State General Administration of the People’s Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ) published the Administrative Measures for Registration of Overseas Manufacturers, known as AQSIQ Decree 145 (https://gain.fas.usda.gov/ Recent%20GAIN%20Publications/ Registration%20of%20Overseas%20 Food%20Manufacturing%20 Facilities%20_Beijing_China%20%20Peoples%20Republic%20of_6-272012.pdf), which became effective May 1, 2012. AQSIQ Decree 145, among other requirements, mandates that VerDate Sep<11>2014 18:22 Dec 01, 2017 Jkt 244001 foreign competent authorities provide the Certification and Accreditation Administration of China (CNCA) with a ‘‘name list of overseas manufacturers of imported food applying for registration’’ with CNCA for each commodity that CNCA has deemed to require registration. As of June 2017, milk and milk products, seafood, infant formula, and formula for young children are among the commodities for which CNCA requires registration of overseas manufacturers under AQSIQ Decree 145. CNCA has recognized FDA/CFSAN (Center for Food Safety and Applied Nutrition) as the competent food safety authority in the United States to establish and maintain lists of U.S. establishments that intend to export U.S. milk and milk products, seafood, infant formula, and/or formula for young children to China, including the corresponding products manufactured by each establishment and intended for export to China. To implement AQSIQ Decree 145, FDA and CNCA entered into a Memorandum of Understanding (China MOU) on June 15, 2017, which sets out the two Agencies’ intent to facilitate the conditions under which U.S. manufacturers/processors can export to China milk and milk products, seafood, infant formula, and/or formula for young children. Under the China MOU, FDA intends to establish and maintain lists that identify U.S. manufacturers/processors that have expressed interest to FDA in exporting milk and milk products, seafood, infant formula, and/or formula for young children to China; are subject to our jurisdiction; and have been found by FDA to be in good regulatory standing with FDA, including a finding by FDA that, during the most recent facility inspection, the manufacturers/ processors have been found to be in substantial compliance with all applicable FDA regulations, including, but not limited to, current good manufacturing practice requirements for the identified products for export to China. Further, the China MOU provides for FDA to receive evidence that the manufacturer/processor has been certified by a third-party certification body—as acknowledged by CNCA—to meet the relevant standards, laws, and regulations of China for the identified food products for export to China. On June 28, 2017, FDA issued a guidance document entitled ‘‘Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 57283 Children Manufacturers/Processors with Interest in Exporting to China’’ which can be found at https://www.fda.gov/ Food/GuidanceRegulation/default.htm. The guidance informs industry of information that FDA and CNCA will collect to manage the listing of these manufacturers/processors and foods for export to China pursuant to AQSIQ Decree 145 and the China MOU. In accordance with 5 CFR 1320.13, FDA requested emergency review and approval of the collections of information found in the guidance document. The routine course of approval would have delayed our ability to collect the information from firms and, thus, would have been disruptive in our efforts to facilitate exports of food in compliance with requirements established by China in AQSIQ Decree 145. OMB granted the approval under emergency clearance procedures on June 27, 2017. FDA uses the information submitted by manufacturers/processors to consider them for inclusion on FDA’s lists of eligible manufacturers/processors who may ship food products to China, which we maintain. Updates to the FDA lists are sent to CNCA, which publishes its version of the information in the FDA lists on China’s Web site (http:// english.cnca.gov.cn/) on a quarterly basis. The purpose of the lists is to assist China in its determination of which U.S. milk and milk product, seafood, infant formula, or formula for young children manufacturers/processors are eligible to import these products into China under applicable Chinese law. Currently FDA maintains lists for milk and milk product, seafood, infant formula, and formula for young children but FDA wants to be prepared if CNCA requires listing of manufacturers/processors of other CFSAN-regulated products in the future. As such, the information collection request is not limited to milk and milk product, seafood, infant formula, and formula for young children but also may include other CFSANregulated products. In the Federal Register of September 19, 2017 (82 FR 43761), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. One comment was received but was not responsive to the four information collection topics solicited in the notice and therefore is not addressed. FDA estimates the burden of this collection of information as follows: E:\FR\FM\04DEN1.SGM 04DEN1 57284 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Guidance recommendations Number of responses per respondent Total annual responses Average burden per response Total hours New written requests to be placed on the lists ................... Third-party certification ........................................................ Biennial update .................................................................... Third-party certification biennial update ............................... Occasional updates ............................................................. 370 370 555 555 100 1 1 1 1 1 370 370 555 555 100 1 21 1 21 0.5 370 7,770 555 11,655 50 Total .............................................................................. ........................ ........................ ........................ ........................ 20,400 sradovich on DSK3GMQ082PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This is a newly established information collection. Based on our experience maintaining other export lists, we estimate that, annually, an average of 370 new manufacturers/ processors will submit written requests to be placed on the China lists. The estimate of the number of hours that it will take a manufacturer/processor to gather the information needed to be placed on a list or update its information is based on FDA’s experience with manufacturers/ processors submitting similar requests. FDA believes that the information to be submitted will be readily available to manufacturers/processors. We estimate that a firm will require 1 hour to read the guidance, to gather the information needed, and to prepare a communication to FDA that contains the information needed to request that the manufacturer/processor be placed on a list. To be placed on a list, manufacturers/ processors should provide FDA with evidence that they have obtained thirdparty certification from a CNCAacknowledged certifier that the manufacturer/processor complies with the standards, laws and regulations of China according to relevant requirements specified in AQSIQ Decree 145. Based on our experience with other certification programs, FDA estimates that it will take each new manufacturer/ processor about 21 hours to complete the third-party certification process for a total of 7,770 burden hours (370 manufacturers/processors × 21 hours). Under the guidance, every 2 years each manufacturer/processor on the lists must provide updated information to remain on the lists. FDA estimates that each year approximately half of the manufacturers/processors on the lists, or 555 manufacturers/processors (1110 manufacturers/processors × 0.5 = 555), will resubmit the information to remain on the lists. We estimate that a manufacturer/processor already on the lists will require 1 hour to biennially update and resubmit the information to VerDate Sep<11>2014 18:22 Dec 01, 2017 Jkt 244001 FDA, including time reviewing the information and corresponding with FDA, for a total of 555 hours. During the biennial update, manufacturers/processors also need to be recertified by a third-party certifier to remain on the lists. FDA estimates that each year approximately half of the manufacturers/processors on the lists, 555 manufacturers/processors (1110 manufacturers/processors × 0.5 = 555), will get recertified. We estimate that it will take each manufacturer/processor about 21 hours to complete the certification process for a total of 11,655 burden hours (555 manufacturers/ processors × 21 hours). FDA expects that, each year, approximately 100 manufacturers/ processors will need to submit an occasional update and each manufacturer/processor will require 0.5 hours to prepare a communication to FDA reporting the change, for a total of 50 hours. Dated: November 29, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26042 Filed 12–1–17; 8:45 am] BILLING CODE 4164–01–P individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; CTSA. Date: February 21, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, Independence Ballrooms 1 & 2, 6711 Democracy Blvd., Bethesda, MD 20817. Contact Person: Carol Lambert, Ph.D., Acting Director, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1076, Bethesda, MD 20892, 301–435– 0814, lambert@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: November 28, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–25982 Filed 12–1–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57282-57284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26042]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0192]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Establishing and 
Maintaining Lists of United States Manufacturers/Processors With 
Interest in Exporting Center for Food Safety and Applied Nutrition-
Regulated Products to China

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

[[Page 57283]]


DATES: Fax written comments on the collection of information by January 
3, 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 0910-0839. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Establishing and Maintaining Lists of U.S. Manufacturers/Processors 
With Interest in Exporting CFSAN-Regulated Products to China--21 U.S.C. 
371 OMB Control Number 0910-0839--Extension

    The United States exports a large volume and variety of foods in 
international trade. For certain food products, foreign governments may 
require assurances from the responsible authority of the country of 
origin of an imported food product that the manufacturer/processor of 
the food product is in compliance with applicable country of origin 
regulatory requirements. Some foreign governments establish additional 
requirements with which exporters are required to comply.
    In August 2011, China's State General Administration of the 
People's Republic of China for Quality Supervision and Inspection and 
Quarantine (AQSIQ) published the Administrative Measures for 
Registration of Overseas Manufacturers, known as AQSIQ Decree 145 
(https://gain.fas.usda.gov/Recent%20GAIN%20Publications/Registration%20of%20Overseas%20Food%20Manufacturing%20Facilities%20_Beijing_China%20-%20Peoples%20Republic%20of_6-27-2012.pdf), which became 
effective May 1, 2012. AQSIQ Decree 145, among other requirements, 
mandates that foreign competent authorities provide the Certification 
and Accreditation Administration of China (CNCA) with a ``name list of 
overseas manufacturers of imported food applying for registration'' 
with CNCA for each commodity that CNCA has deemed to require 
registration. As of June 2017, milk and milk products, seafood, infant 
formula, and formula for young children are among the commodities for 
which CNCA requires registration of overseas manufacturers under AQSIQ 
Decree 145. CNCA has recognized FDA/CFSAN (Center for Food Safety and 
Applied Nutrition) as the competent food safety authority in the United 
States to establish and maintain lists of U.S. establishments that 
intend to export U.S. milk and milk products, seafood, infant formula, 
and/or formula for young children to China, including the corresponding 
products manufactured by each establishment and intended for export to 
China. To implement AQSIQ Decree 145, FDA and CNCA entered into a 
Memorandum of Understanding (China MOU) on June 15, 2017, which sets 
out the two Agencies' intent to facilitate the conditions under which 
U.S. manufacturers/processors can export to China milk and milk 
products, seafood, infant formula, and/or formula for young children.
    Under the China MOU, FDA intends to establish and maintain lists 
that identify U.S. manufacturers/processors that have expressed 
interest to FDA in exporting milk and milk products, seafood, infant 
formula, and/or formula for young children to China; are subject to our 
jurisdiction; and have been found by FDA to be in good regulatory 
standing with FDA, including a finding by FDA that, during the most 
recent facility inspection, the manufacturers/processors have been 
found to be in substantial compliance with all applicable FDA 
regulations, including, but not limited to, current good manufacturing 
practice requirements for the identified products for export to China. 
Further, the China MOU provides for FDA to receive evidence that the 
manufacturer/processor has been certified by a third-party 
certification body--as acknowledged by CNCA--to meet the relevant 
standards, laws, and regulations of China for the identified food 
products for export to China. On June 28, 2017, FDA issued a guidance 
document entitled ``Establishing and Maintaining a List of U.S. Milk 
and Milk Product, Seafood, Infant Formula, and Formula for Young 
Children Manufacturers/Processors with Interest in Exporting to China'' 
which can be found at https://www.fda.gov/Food/GuidanceRegulation/default.htm. The guidance informs industry of information that FDA and 
CNCA will collect to manage the listing of these manufacturers/
processors and foods for export to China pursuant to AQSIQ Decree 145 
and the China MOU.
    In accordance with 5 CFR 1320.13, FDA requested emergency review 
and approval of the collections of information found in the guidance 
document. The routine course of approval would have delayed our ability 
to collect the information from firms and, thus, would have been 
disruptive in our efforts to facilitate exports of food in compliance 
with requirements established by China in AQSIQ Decree 145. OMB granted 
the approval under emergency clearance procedures on June 27, 2017.
    FDA uses the information submitted by manufacturers/processors to 
consider them for inclusion on FDA's lists of eligible manufacturers/
processors who may ship food products to China, which we maintain. 
Updates to the FDA lists are sent to CNCA, which publishes its version 
of the information in the FDA lists on China's Web site (http://english.cnca.gov.cn/) on a quarterly basis. The purpose of the lists is 
to assist China in its determination of which U.S. milk and milk 
product, seafood, infant formula, or formula for young children 
manufacturers/processors are eligible to import these products into 
China under applicable Chinese law. Currently FDA maintains lists for 
milk and milk product, seafood, infant formula, and formula for young 
children but FDA wants to be prepared if CNCA requires listing of 
manufacturers/processors of other CFSAN-regulated products in the 
future. As such, the information collection request is not limited to 
milk and milk product, seafood, infant formula, and formula for young 
children but also may include other CFSAN-regulated products.
    In the Federal Register of September 19, 2017 (82 FR 43761), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. One comment was received 
but was not responsive to the four information collection topics 
solicited in the notice and therefore is not addressed.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 57284]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Guidance recommendations         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
New written requests to be                   370               1             370               1             370
 placed on the lists............
Third-party certification.......             370               1             370              21           7,770
Biennial update.................             555               1             555               1             555
Third-party certification                    555               1             555              21          11,655
 biennial update................
Occasional updates..............             100               1             100             0.5              50
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          20,400
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This is a newly established information collection. Based on our 
experience maintaining other export lists, we estimate that, annually, 
an average of 370 new manufacturers/processors will submit written 
requests to be placed on the China lists. The estimate of the number of 
hours that it will take a manufacturer/processor to gather the 
information needed to be placed on a list or update its information is 
based on FDA's experience with manufacturers/processors submitting 
similar requests. FDA believes that the information to be submitted 
will be readily available to manufacturers/processors. We estimate that 
a firm will require 1 hour to read the guidance, to gather the 
information needed, and to prepare a communication to FDA that contains 
the information needed to request that the manufacturer/processor be 
placed on a list.
    To be placed on a list, manufacturers/processors should provide FDA 
with evidence that they have obtained third-party certification from a 
CNCA-acknowledged certifier that the manufacturer/processor complies 
with the standards, laws and regulations of China according to relevant 
requirements specified in AQSIQ Decree 145. Based on our experience 
with other certification programs, FDA estimates that it will take each 
new manufacturer/processor about 21 hours to complete the third-party 
certification process for a total of 7,770 burden hours (370 
manufacturers/processors x 21 hours).
    Under the guidance, every 2 years each manufacturer/processor on 
the lists must provide updated information to remain on the lists. FDA 
estimates that each year approximately half of the manufacturers/
processors on the lists, or 555 manufacturers/processors (1110 
manufacturers/processors x 0.5 = 555), will resubmit the information to 
remain on the lists. We estimate that a manufacturer/processor already 
on the lists will require 1 hour to biennially update and resubmit the 
information to FDA, including time reviewing the information and 
corresponding with FDA, for a total of 555 hours.
    During the biennial update, manufacturers/processors also need to 
be recertified by a third-party certifier to remain on the lists. FDA 
estimates that each year approximately half of the manufacturers/
processors on the lists, 555 manufacturers/processors (1110 
manufacturers/processors x 0.5 = 555), will get recertified. We 
estimate that it will take each manufacturer/processor about 21 hours 
to complete the certification process for a total of 11,655 burden 
hours (555 manufacturers/processors x 21 hours).
    FDA expects that, each year, approximately 100 manufacturers/
processors will need to submit an occasional update and each 
manufacturer/processor will require 0.5 hours to prepare a 
communication to FDA reporting the change, for a total of 50 hours.

    Dated: November 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26042 Filed 12-1-17; 8:45 am]
BILLING CODE 4164-01-P