82 FR 57282 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 231 (December 4, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 231 (December 4, 2017)
| Page Range | 57282-57284 | |
| FR Document | 2017-26042 |
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)] [Notices] [Pages 57282-57284] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. 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
![57282 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
https://www.fda.gov/downloads/ standards recognized by FDA. The II. Listing of New Entries, Recognition
MedicalDevices/DeviceRegulation Agency maintains hypertext markup List Number: 048
andGuidance/GuidanceDocuments/ language (HTML) and portable
ucm077295.pdf. document format (PDF) versions of the In table 1, FDA provides the listing of
Modifications to the initial list of list of FDA Recognized Consensus new entries and consensus standards
recognized standards, as published in Standards. Additional information on added as modifications to the list of
the Federal Register, can be accessed at the Agency’s standards program is recognized standards under Recognition
https://www.fda.gov/MedicalDevices/ available at https://www.fda.gov/ List Number: 048. FDA lists
DeviceRegulationandGuidance/ MedicalDevices/DeviceRegulation modifications the Agency is making that
Standards/ucm123792.htm. involve the initial addition of standards
andGuidance/Standards/default.htm.
These notices describe the addition, not previously recognized by FDA.
withdrawal, and revision of certain
TABLE 1—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard 1 Reference No. and date
A. Radiology
12–307 ................. Radiation therapy readiness check ................................................................. AAMI RT2:2017.
B. Software/Informatics
13–98 ................... Information technology—IS0 7-bit coded character set for information inter- ISO/IEC 646 Third edition 1991–12–15.
change.
13–99 ................... Information technology—Automatic identification and data capture tech- ISO/IEC 15459–2 Third edition 2015–03–01.
niques—Unique identification—Part 2: Registration procedures.
13–100 ................. Information technology—Automatic identification and data capture tech- ISO/IEC 15459–4 Third edition 2014–11–15
niques—Unique identification—Part 4: Individual products and product Corrected version 2016–09–01.
packages.
13–101 ................. Information technology—Automatic identification and data capture tech- ISO/IEC 15459–6 Second edition 2014–11–
niques—Unique identification—Part 6: Groupings. 15 Corrected version 2016–09–01.
13–102 ................. Application of risk management for IT-networks incorporating medical de- IEC TR 80001–2–8 Edition 1.0 2016–05.
vices—Part 2–8: Application guidance—Guidance on standards for estab-
lishing the security capabilities identified in IEC TR 80001–2–2.
13–103 ................. Application of risk management for IT-networks incorporating medical de- IEC TR 80001–2–9 Edition 1.0 2017–01.
vices—Part 2–9: Application guidance—Guidance for use of security as-
surance cases to demonstrate confidence in IEC TR 80001–2–2 security
capabilities.
1 All standard titles in this table conform to the style requirements of the respective organizations.
III. List of Recognized Standards following information: (1) Title of the DEPARTMENT OF HEALTH AND
FDA maintains the current list of FDA standard, (2) any reference number and HUMAN SERVICES
Recognized Consensus Standards in a date, (3) name and electronic or mailing
searchable database that may be address of the requestor, (4) a proposed Food and Drug Administration
accessed at https:// list of devices for which a declaration of
www.accessdata.fda.gov/scripts/cdrh/ conformity to this standard should [Docket No. FDA–2014–N–0192]
cfdocs/cfStandards/search.cfm. FDA routinely apply, and (5) a brief
will be incorporating the modifications identification of the testing or Agency Information Collection
described in this notice into the performance or other characteristics of Activities; Submission for Office of
database and, upon publication in the the device(s) that would be addressed Management and Budget Review;
Federal Register, this recognition of by a declaration of conformity. Comment Request; Establishing and
consensus standards will be effective. Maintaining Lists of United States
Dated: November 29, 2017.
FDA will be announcing additional Manufacturers/Processors With
modifications and revisions to the list of Leslie Kux, Interest in Exporting Center for Food
recognized consensus standards, as Associate Commissioner for Policy. Safety and Applied Nutrition-Regulated
needed, in the Federal Register once a [FR Doc. 2017–26043 Filed 12–1–17; 8:45 am] Products to China
year, or more often if necessary. BILLING CODE 4164–01–P
AGENCY: Food and Drug Administration,
IV. Recommendation of Standards for
Recognition by FDA HHS.
Any person may recommend ACTION: Notice.
consensus standards as candidates for
sradovich on DSK3GMQ082PROD with NOTICES
recognition under section 514 of the SUMMARY: The Food and Drug
FD&C Act by submitting such Administration (FDA) is announcing
recommendations, with reasons for the that a proposed collection of
recommendation, to information has been submitted to the
CDRHStandardsStaff@fda.hhs.gov. To Office of Management and Budget
be considered, such recommendations (OMB) for review and clearance under
should contain, at a minimum, the the Paperwork Reduction Act of 1995.
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![57284 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Guidance recommendations responses per burden per Total hours
respondents responses
respondent response
New written requests to be placed on the lists ................... 370 1 370 1 370
Third-party certification ........................................................ 370 1 370 21 7,770
Biennial update .................................................................... 555 1 555 1 555
Third-party certification biennial update ............................... 555 1 555 21 11,655
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 FDA, including time reviewing the individuals associated with the grant
information collection. Based on our information and corresponding with applications, the disclosure of which
experience maintaining other export FDA, for a total of 555 hours. would constitute a clearly unwarranted
lists, we estimate that, annually, an During the biennial update, invasion of personal privacy.
average of 370 new manufacturers/ manufacturers/processors also need to Name of Committee: National Center for
processors will submit written requests be recertified by a third-party certifier to Advancing Translational Sciences Special
to be placed on the China lists. The remain on the lists. FDA estimates that Emphasis Panel; CTSA.
estimate of the number of hours that it each year approximately half of the Date: February 21, 2018.
will take a manufacturer/processor to manufacturers/processors on the lists, Time: 8:00 a.m. to 5:00 p.m.
gather the information needed to be 555 manufacturers/processors (1110 Agenda: To review and evaluate grant
manufacturers/processors × 0.5 = 555), applications.
placed on a list or update its
Place: Bethesda Marriott Suites,
information is based on FDA’s will get recertified. We estimate that it
Independence Ballrooms 1 & 2, 6711
experience with manufacturers/ will take each manufacturer/processor Democracy Blvd., Bethesda, MD 20817.
processors submitting similar requests. about 21 hours to complete the Contact Person: Carol Lambert, Ph.D.,
FDA believes that the information to be certification process for a total of 11,655 Acting Director, Office of Scientific Review,
submitted will be readily available to burden hours (555 manufacturers/ National Center for Advancing Translational
manufacturers/processors. We estimate processors × 21 hours). Sciences (NCATS), National Institutes of
that a firm will require 1 hour to read FDA expects that, each year, Health, 6701 Democracy Blvd., Democracy 1,
approximately 100 manufacturers/ Room 1076, Bethesda, MD 20892, 301–435–
the guidance, to gather the information
processors will need to submit an 0814, lambert@mail.nih.gov.
needed, and to prepare a
occasional update and each (Catalogue of Federal Domestic Assistance
communication to FDA that contains
manufacturer/processor will require 0.5 Program Nos. 93.859, Pharmacology,
the information needed to request that Physiology, and Biological Chemistry
the manufacturer/processor be placed hours to prepare a communication to Research; 93.350, B—Cooperative
on a list. FDA reporting the change, for a total of Agreements; 93.859, Biomedical Research
To be placed on a list, manufacturers/ 50 hours. and Research Training, National Institutes of
processors should provide FDA with Dated: November 29, 2017. Health, HHS)
evidence that they have obtained third- Leslie Kux, Dated: November 28, 2017.
party certification from a CNCA- Associate Commissioner for Policy. David Clary,
acknowledged certifier that the [FR Doc. 2017–26042 Filed 12–1–17; 8:45 am] Program Analyst, Office of Federal Advisory
manufacturer/processor complies with BILLING CODE 4164–01–P Committee Policy.
the standards, laws and regulations of [FR Doc. 2017–25982 Filed 12–1–17; 8:45 am]
China according to relevant BILLING CODE 4140–01–P
requirements specified in AQSIQ Decree DEPARTMENT OF HEALTH AND
145. Based on our experience with other HUMAN SERVICES
certification programs, FDA estimates DEPARTMENT OF HEALTH AND
that it will take each new manufacturer/ National Institutes of Health HUMAN SERVICES
processor about 21 hours to complete
the third-party certification process for National Center for Advancing National Institutes of Health
a total of 7,770 burden hours (370 Translational Sciences; Notice of
manufacturers/processors × 21 hours). Closed Meeting National Institute of Diabetes and
Under the guidance, every 2 years Digestive and Kidney Diseases; Notice
Pursuant to section 10(d) of the
each manufacturer/processor on the lists of Closed Meetings
Federal Advisory Committee Act, as
must provide updated information to amended, notice is hereby given of the Pursuant to section 10(d) of the
remain on the lists. FDA estimates that following meeting. Federal Advisory Committee Act, as
each year approximately half of the The meeting will be closed to the amended, notice is hereby given of the
manufacturers/processors on the lists, or public in accordance with the
sradovich on DSK3GMQ082PROD with NOTICES
following meetings.
555 manufacturers/processors (1110 provisions set forth in sections The meetings will be closed to the
manufacturers/processors × 0.5 = 555), 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., public in accordance with the
will resubmit the information to remain as amended. The grant applications and provisions set forth in sections
on the lists. We estimate that a the discussions could disclose 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
manufacturer/processor already on the confidential trade secrets or commercial as amended. The grant applications and
lists will require 1 hour to biennially property such as patentable material, the discussions could disclose
update and resubmit the information to and personal information concerning confidential trade secrets or commercial
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Document Created: 2017-12-02 00:40:30
Document Modified: 2017-12-02 00:40:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by January 3, 2018. | |
| 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, [email protected] | |
| FR Citation | 82 FR 57282 |
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