81 FR 54809 - Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request; Voluntary Qualified Importer Program Guidance for Industry
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 159 (August 17, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 159 (August 17, 2016)
| Page Range | 54809-54811 | |
| FR Document | 2016-19643 |
[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)] [Notices] [Pages 54809-54811] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19643] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0144] Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request; Voluntary Qualified Importer Program Guidance for Industry 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. DATES: Fax written comments on the collection of information by September 16, 2016. 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-NEW and title, ``Voluntary Qualified Importer Program Guidance for Industry.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A63, North Bethesda, MD 20852, [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. FDA's Voluntary Qualified Importer Program (VQIP); Guidance for Industry OMB Control Number 0910--NEW The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Under FSMA, those that import food have a responsibility to ensure that their suppliers produce food that meets U.S. safety standards. FSMA also requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods by importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified under FDA's accredited third-party audit program, as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public [[Page 54810]] health by allowing FDA to focus its resources on food entries that pose a higher risk to public health. Section 302 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding new section 806, Voluntary Qualified Importer Program (21 U.S.C. 384b). Section 806(a)(1) of the FD&C Act directs FDA to establish this voluntary program for the expedited review and importation of food, and to establish a process for the issuance of a facility certification to accompany food offered for importation by importers participating in VQIP. Section 806(a)(2) directs FDA to issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with VQIP. Accordingly, in the Federal Register of June 5, 2015 (80 FR 32136), FDA published a notice announcing the availability of a draft guidance entitled ``FDA's Voluntary Qualified Importer Program,'' and invited public comment regarding the guidance as well as the information collection provisions associated with the guidance (80 FR 32136 at 32138). In response to the solicitation of comments regarding the information collection provisions, the Agency received multiple comments. Two comments suggested that FDA's recordkeeping and reporting estimates were too low. Because neither comment provided justification for why the burden calculation might be too low or offered alternative calculations, we have retained our original estimates noting that, upon implementation of the program, we will again invite public comment on the information collection burden and make adjustments to our estimates accordingly. One comment attributed costs to the information collection but did not provide a basis for the calculations provided. We therefore have not adopted the comment, but again note that public input will be solicited on the information collection upon implementation of the program. Finally, one comment objected to the provision regarding respondents obtaining a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number and providing it to the Agency. We have determined that the DUNS number is an appropriate unique facility identifier during Foreign Supplier Verification Program (FSVP) rulemaking. We expect that most VQIP importers will also be FSVP importers and will have obtained a DUNS number. Description of Respondents: Respondents to the collection are importers of human or animal food. We estimate the burden for the collection of information as follows: Table 1--Estimated One-Time Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Information collection activity Number of records per Total one-time per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Quality Assurance Program (QAP) preparation........................ 200 1 200 160 32,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We estimate it will take a VQIP applicant no longer than 10 hours to develop its QAP, including compiling its company profile, organizational structure, corporate quality policy statement, procedures for QAP implementation, food safety and food defense policies and procedures, and procedures for record retention. On average, the preparation of a QAP by a VQIP applicant is estimated at approximately 160 hours (110 + 40 + 10). In estimation of the one-time recordkeeping burden to prepare a QAP manual, we assume that VQIP importers do not already have a similar manual in place (e.g., food safety plan under the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117); food defense plan under the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration regulation (IA regulation) (21 CFR part 121)). The one-time recordkeeping burden for 200 VQIP applicants to prepare QAPs is estimated at 32,000 hours (200 applicants x 160 hours/applicant) (see table 1). To the extent that some importers do have QAP manuals in place, the burden would be overestimated. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Information collection activity Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- QAP modification................................................... 200 1 200 16 3,200 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. A VQIP importer is expected to update its QAP on an ongoing basis. We estimate it would take 10 percent of the effort to prepare the QAP, or 16 hours, to update the QAP each year. Therefore, we estimate the annual recordkeeping burden of modification of the QAP for 200 VQIP importers at 3,200 hours (200 importers x 16 hours/importer). The VQIP food defense security criterion is similar to the Food Defense Plan requirement under Sec. 121.126 (21 CFR 121.126) in the IA regulation. Under the IA regulation, the food defense plan must include the written identification of actionable process steps, focused mitigation strategies, procedures for monitoring, corrective action procedures, and verification procedures. Therefore, we estimate that, on average, it would take 40 hours for an applicant to prepare the food defense portion of the VQIP QAP. [[Page 54811]] Table 3--Estimated One-Time Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Information collection activity Number of responses per Total one-time burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Initial VQIP application........ 100 1 100 80 8,000 Initial VQIP application w/ 100 1 100 100 10,000 additional information......... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 18,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital or operating and maintenance costs associated with the collection of information. The guidance will inform food importers of application procedures for VQIP. We estimate that up to 200 qualified importers will be accepted in the first year of VQIP. We estimate that it will take 80 person-hours to compile all the relevant information and complete the application for the VQIP program. For the purpose of this analysis, we assume that 50 percent of all applications received will require additional information and it would take an additional 20 person-hours by the importer to provide that information. Therefore, we estimate that 100 importers will spend 8,000 hours (80 hours/importer x 100 importers) and 100 importers will spend 10,000 hours (100 hours/ importer x 100 importers) to submit their initial VQIP applications for a total one-time reporting burden of 18,000 hours (see table 3). Table 4--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Information collection activity Number of responses per Total annual burden per Total hours responses respondent responses response ---------------------------------------------------------------------------------------------------------------- Subsequent year VQIP application 200 1 200 20 4,000 Request to reinstate 2 1 2 10 20 participation.................. ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 4,020 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital or operating and maintenance costs associated with the collection of information. The guidance states that each VQIP participant will submit to FDA a notice of intent to participate in VQIP on an annual basis. We expect that each of the expected 200 importers in VQIP would apply in the subsequent year to participate in VQIP. We expect that an application to participate in VQIP in a subsequent year will take significantly less time to prepare than the initial application. We use 25 percent of the amount of effort to prepare and submit the initial application for acceptance in VQIP. Therefore, it is expected that, on average, each VQIP importer will spend 20 hours to complete and submit a VQIP application for each subsequent year. The annual burden of completing a subsequent year application to participate in VQIP status by 200 importers is estimated at 4,000 hours (200 applications x 20 hours/ application) (see table 4). Finally, we have added to the VQIP estimated annual reporting burden an estimate of the burden associated with importers' requests to reinstate participation in VQIP after their participation is revoked. We believe most participants will not need to use this provision, and we have included an estimate that reflects this. Upon implementation of the VQIP, we will reevaluate our estimate for future OMB submission and revise it accordingly. Dated: August 12, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016-19643 Filed 8-16-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 54809
Hampshire Ave., Hillandale Building, solid-state forms, the data that should be (OMB) for review and clearance under
4th Floor, Silver Spring, MD 20993– submitted to support the classification, the Paperwork Reduction Act of 1995.
0002. Send one self-addressed adhesive and the regulatory implications of such DATES: Fax written comments on the
label to assist that office in processing a classification. collection of information by September
your requests. See the SUPPLEMENTARY This draft guidance is being issued 16, 2016.
INFORMATION section for electronic consistent with FDA’s good guidance ADDRESSES: To ensure that comments on
access to the draft guidance document. practices regulation (21 CFR 10.115). the information collection are received,
FOR FURTHER INFORMATION CONTACT: The draft guidance, when finalized, will OMB recommends that written
Richard (Rik) Lostritto, Center for Drug represent the current thinking of FDA comments be faxed to the Office of
Evaluation and Research, Food and on regulatory classification of Information and Regulatory Affairs,
Drug Administration, 10903 New pharmaceutical co-crystals. It does not OMB, Attn: FDA Desk Officer, FAX:
Hampshire Ave., Bldg. 51, Rm. 4148, establish any rights for any person and 202–395–7285, or emailed to
Silver Spring, MD 20993–0002, 301– is not binding on FDA or the public. oira_submission@omb.eop.gov. All
796–1697. You can use an alternative approach if comments should be identified with the
SUPPLEMENTARY INFORMATION:
it satisfies the requirements of the OMB control number 0910–NEW and
applicable statutes and regulations. title, ‘‘Voluntary Qualified Importer
I. Background Program Guidance for Industry.’’ Also
II. The Paperwork Reduction Act of
FDA is announcing the availability of 1995 include the FDA docket number found
a draft guidance for industry entitled in brackets in the heading of this
This guidance refers to previously document.
‘‘Regulatory Classification of
approved collections of information
Pharmaceutical Co-Crystals.’’ This FOR FURTHER INFORMATION CONTACT: FDA
found in FDA regulations. This
guidance provides NDA and ANDA PRA Staff, Office of Operations, Food
guidance refers to information
applicants with information on the and Drug Administration, Three White
collection provisions that are subject to
appropriate regulatory classification of Flint North, 11601 Landsdown St.,
review by the Office of Management and
pharmaceutical co-crystal solid-state 10A63, North Bethesda, MD 20852,
Budget (OMB) under the Paperwork
forms. PRAStaff@fda.hhs.gov.
Reduction Act of 1995 (44 U.S.C. 3501–
Co-crystals are crystalline materials SUPPLEMENTARY INFORMATION: In
3520). The collections of information in
composed of two or more different compliance with 44 U.S.C. 3507, FDA
21 CFR 314.50(d)(1) and 314.94(a)(5)
molecules, typically drug and co-crystal has submitted the following proposed
and (a)(9) have been approved under
formers (‘‘coformers’’), in the same collection of information to OMB for
OMB control number 0910–0001.
crystal lattice. Pharmaceutical co- review and clearance.
crystals have opened up opportunities III. Electronic Access
for engineering solid-state forms beyond Persons with access to the Internet FDA’s Voluntary Qualified Importer
conventional solid-state forms of an may obtain the draft guidance at either Program (VQIP); Guidance for Industry
active pharmaceutical ingredient (API), http://www.fda.gov/Drugs/Guidance OMB Control Number 0910—NEW
such as salts and polymorphs. Co- ComplianceRegulatoryInformation/ The FDA Food Safety Modernization
crystals can be tailored to enhance drug Guidances/default.htm or http:// Act (FSMA) (Pub. L. 111–353) enables
product bioavailability and stability and www.regulations.gov. FDA to better protect public health by
to enhance the processability of APIs helping to ensure the safety and security
Dated: August 11, 2016.
during drug product manufacture. of the food supply. It enables FDA to
Another advantage of co-crystals is that Jeremy Sharp,
focus more on preventing food safety
they generate a diverse array of solid- Deputy Commissioner for Policy, Planning, problems rather than relying primarily
state forms for APIs that lack ionizable Legislation, and Analysis.
on reacting to problems after they occur.
functional groups, which is a [FR Doc. 2016–19596 Filed 8–16–16; 8:45 am] FSMA recognizes the important role
prerequisite for salt formation. BILLING CODE 4164–01–P industry plays in ensuring the safety of
This guidance revises the guidance for the food supply, including the adoption
industry ‘‘Regulatory Classification of of modern systems of preventive
Pharmaceutical Co-Crystals’’ issued in DEPARTMENT OF HEALTH AND controls in food production. Under
April 2013, which classifies co-crystals HUMAN SERVICES FSMA, those that import food have a
as a drug product intermediate (or as an responsibility to ensure that their
Food and Drug Administration
in-process material). This classification suppliers produce food that meets U.S.
has contributed to uncertainty regarding [Docket No. FDA–2011–N–0144] safety standards.
the interpretation of the guidance FSMA also requires FDA to establish
because in a commercial setting, co- Agency Information Collection a voluntary, fee-based program for the
crystals are typically manufactured in Activities; Submission for Office of expedited review and importation of
drug substance facilities, yet when Management and Budget Review foods by importers who achieve and
classified as a drug product Comment Request; Voluntary Qualified maintain a high level of control over the
intermediate, additional current good Importer Program Guidance for safety and security of their supply
manufacturing practice requirements Industry chains. This control includes
apply. Therefore, the guidance has not AGENCY: Food and Drug Administration, importation of food from facilities that
been conducive to the development of have been certified under FDA’s
mstockstill on DSK3G9T082PROD with NOTICES
HHS.
co-crystals. In response to this and other ACTION: Notice. accredited third-party audit program, as
feedback from stakeholders, FDA has well as other measures that support a
reconsidered the appropriate SUMMARY: The Food and Drug high level of confidence in the safety
classification of co-crystals. This Administration (FDA) is announcing and security of the food they import.
revision addresses the concern by that a proposed collection of Expedited entry incentivizes importers
providing information on the information has been submitted to the to adopt a robust system of supply chain
appropriate classification of co-crystal Office of Management and Budget management and further benefits public
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![Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 54811
TABLE 3—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of Average
Number of Total one-time
Information collection activity responses per burden per Total hours
respondents responses
respondent response
Initial VQIP application ......................................................... 100 1 100 80 8,000
Initial VQIP application w/additional information ................. 100 1 100 100 10,000
Total .............................................................................. ........................ ........................ ........................ ........................ 18,000
1 There are no capital or operating and maintenance costs associated with the collection of information.
The guidance will inform food program. For the purpose of this (80 hours/importer × 100 importers) and
importers of application procedures for analysis, we assume that 50 percent of 100 importers will spend 10,000 hours
VQIP. We estimate that up to 200 all applications received will require (100 hours/importer × 100 importers) to
qualified importers will be accepted in additional information and it would submit their initial VQIP applications
the first year of VQIP. We estimate that take an additional 20 person-hours by for a total one-time reporting burden of
it will take 80 person-hours to compile the importer to provide that 18,000 hours (see table 3).
all the relevant information and information. Therefore, we estimate that
complete the application for the VQIP 100 importers will spend 8,000 hours
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Information collection activity responses per burden per Total hours
responses responses
respondent response
Subsequent year VQIP application ...................................... 200 1 200 20 4,000
Request to reinstate participation ........................................ 2 1 2 10 20
Total .............................................................................. ........................ ........................ ........................ ........................ 4,020
1 There are no capital or operating and maintenance costs associated with the collection of information.
The guidance states that each VQIP Dated: August 12, 2016. for donors of human cells, tissues, and
participant will submit to FDA a notice Jeremy Sharp, cellular and tissue-based products
of intent to participate in VQIP on an Deputy Commissioner for Policy, Planning, (HCT/Ps), with recommendations
annual basis. We expect that each of the Legislation, and Analysis. concerning the use of FDA-licensed
expected 200 importers in VQIP would [FR Doc. 2016–19643 Filed 8–16–16; 8:45 am] nucleic acid tests (NAT) in donor testing
apply in the subsequent year to BILLING CODE 4164–01–P for hepatitis B virus (HBV)
participate in VQIP. We expect that an deoxyribonucleic acid (DNA). The
application to participate in VQIP in a guidance finalizes the draft guidance of
subsequent year will take significantly DEPARTMENT OF HEALTH AND the same title dated January 2016 and
less time to prepare than the initial HUMAN SERVICES supplements previous FDA
application. We use 25 percent of the recommendations to HCT/P
amount of effort to prepare and submit Food and Drug Administration establishments concerning donor testing
the initial application for acceptance in [Docket No. FDA–2015–D–5073] for hepatitis B surface antigen (HBsAg)
VQIP. Therefore, it is expected that, on and total antibody to hepatitis B core
average, each VQIP importer will spend Use of Nucleic Acid Tests To Reduce antigen (anti-HBc), in the document
20 hours to complete and submit a VQIP the Risk of Transmission of Hepatitis entitled ‘‘Guidance for Industry:
application for each subsequent year. B Virus From Donors of Human Cells, Eligibility Determination for Donors of
The annual burden of completing a Tissues, and Cellular and Tissue- Human Cells, Tissues, and Cellular and
subsequent year application to Based Products; Guidance for Tissue-Based Products (HCT/Ps)’’ dated
participate in VQIP status by 200 Industry; Availability August 2007 (2007 Donor Eligibility
importers is estimated at 4,000 hours AGENCY: Food and Drug Administration, Guidance).
(200 applications × 20 hours/ HHS. DATES: Submit either electronic or
application) (see table 4). written comments on Agency guidances
ACTION: Notice of availability.
Finally, we have added to the VQIP at any time.
estimated annual reporting burden an SUMMARY: The Food and Drug ADDRESSES: You may submit comments
estimate of the burden associated with Administration (FDA or Agency) is as follows:
importers’ requests to reinstate announcing the availability of a
participation in VQIP after their document entitled ‘‘Use of Nucleic Acid Electronic Submissions
mstockstill on DSK3G9T082PROD with NOTICES
participation is revoked. We believe Tests to Reduce the Risk of Submit electronic comments in the
most participants will not need to use Transmission of Hepatitis B Virus from following way:
this provision, and we have included an Donors of Human Cells, Tissues, and • Federal eRulemaking Portal: http://
estimate that reflects this. Upon Cellular and Tissue-Based Products; www.regulations.gov. Follow the
implementation of the VQIP, we will Guidance for Industry.’’ The guidance instructions for submitting comments.
reevaluate our estimate for future OMB document provides establishments that Comments submitted electronically,
submission and revise it accordingly. make donor eligibility determinations including attachments, to
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Document Created: 2018-02-09 11:34:52
Document Modified: 2018-02-09 11:34:52
| 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 September 16, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A63, North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 54809 |
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