83 FR 13132 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 59 (March 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 59 (March 27, 2018)
| Page Range | 13132-13133 | |
| FR Document | 2018-06069 |
[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)] [Notices] [Pages 13132-13133] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06069] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0073] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties 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 (PRA). DATES: Fax written comments on the collection of information by April 26, 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 0910-0704. 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. Guidance on Consultation Procedures: Foods Derived From New Plant Varieties OMB Control Number 0910-0704--Extension This information collection supports the above captioned Agency guidance document. FDA recommends that producers who use biotechnology in the manufacture or development of foods and food ingredients work cooperatively with FDA to ensure that products derived through biotechnology are safe and comply with all applicable legal requirements and has instituted a voluntary consultation process with industry. To facilitate this process the Agency has issued a guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' which is available on our website at https://www.fda.gov/FoodGuidances. The guidance describes FDA's consultation process for the evaluation of information on new plant varieties provided by developers. The Agency believes this consultation process will help ensure that human food and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution. Additionally, such communication will help to ensure that any potential food safety issues regarding a new plant variety are resolved during development, and will help to ensure that all market entry decisions by the industry are made consistently and in full compliance with the standards of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In the Federal Register of December 13, 2017 (82 FR 58619), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. Two comments were received in response to the notice. Overall, the comments supported FDA's need for the information collection and neither comment suggested revising our estimate of the associated burden. However, both comments reminded us that significant resources were invested into developing data upon which respondents rely to bring information to FDA regarding the development of foods derived from new plant varieties. All the more reason, the comments said, FDA should identify mechanisms by which it can better incorporate its experience over time and, where possible, implement more efficient, streamlined review processes for those products similar to those the Agency has reviewed in the past. The comments recommended FDA compare efficiencies with a process at the U.S. Department of Agriculture regarding the review of agricultural biotechnology products. We appreciate this suggestion. FDA strives to allocate its limited resources in ways that maximize protection to the public health and facilitate compliance with existing regulatory requirements implemented to do so. We also look for ways in which we might coordinate our efforts with those by other agencies who share these objectives. Both comments also included the suggestion that FDA develop a less redundant review process (such as reciprocity if no material differences are identified) that better coordinates expertise across the Center for Food Safety and Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM) into a single, efficient review. We appreciate this suggestion as well and, as discussed in the guidance, note the following: [FDA's] Office of Premarket Approval of the CFSAN and the Office of Surveillance and Compliance of the CVM have established a Biotechnology Evaluation Team (BET) to facilitate, and to ensure consistency in the process by which firms consult under the 1992 policy and inform FDA regarding the marketing of bioengineered foods and food ingredients derived from new plant varieties including those developed using rDNA techniques. The BET oversees the consultation process, identifies regulatory and scientific issues that need to be addressed, and once all relevant issues have been adequately addressed, brings the consultation to closure. At the same time, we have shared the comments received in response to this notice under the PRA with the BET. Consistent with our Good Guidance Practice regulations (21 CFR 10.115), FDA welcomes comments on our guidance documents at any time. In consideration of these comments, we have retained the currently approved burden estimated associated with the information collection, which is as follows: [[Page 13133]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average Activity FDA form No. Number of responses per Total annual burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- Initial consultation.................................... None 20 2 40 4 160 Final consultation...................................... 3665 12 1 12 150 1,800 ----------------------------------------------------------------------------------------------- Total............................................... .............. .............. .............. .............. .............. 1,960 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimate is based on the information collection activities discussed below. Initial Consultations Initial consultations are generally a one-time burden, although a developer might return more than once to discuss additional issues before submitting a final consultation. As noted in the guidance, FDA encourages developers to consult early in the development phase of their products, and as often as necessary. Historically, firms developing a new bioengineered plant variety intended for food use have generally initiated consultation with FDA early in the process of developing such a variety, even though there is no legal obligation for such consultation. These consultations have served to make FDA aware of foods and food ingredients before these products are distributed commercially, and have provided FDA with the information necessary to address any potential questions regarding the safety, labeling, or regulatory status of the food or food ingredient. As such, these consultations have provided assistance to both industry and the Agency in exercising their mutual responsibilities under the FD&C Act. FDA estimates that CVM and CFSAN jointly received an average of 40 initial consultations per year in the last 3 years via telephone, email, or written letter. Based on this information, we expect to receive no more than 40 annually in the next 3 years. Final Consultations Final consultations are a one-time burden. At some stage in the process of research and development, a developer will have accumulated the information that the developer believes is adequate to ensure that food derived from the new plant variety is safe and that it demonstrates compliance with the relevant provisions of the FD&C Act. The developer will then be in a position to conclude any ongoing consultation with FDA. The developer submits to FDA a summary of the safety and nutritional assessment that has been conducted about the bioengineered food that is intended to be introduced into commercial distribution. FDA evaluates the submission to ensure that all potential safety and regulatory questions have been addressed. FDA has developed a form that prompts a developer to include certain elements in the final consultation in a standard format: Form FDA 3665 entitled, ``Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation).'' The form, and elements that would be prepared as attachments to the form, can be submitted in electronic format. We base our estimate of the average time to prepare a submission on informal contact with firms that made one or more biotechnology consultation submission under the voluntary biotechnology consultation process. As such, we estimate the average time to prepare a submission for final consultation to be 150 hours. Dated: March 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06069 Filed 3-26-18; 8:45 am] BILLING CODE 4164-01-P
![13132 Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
enumerated through their CMS FOR FURTHER INFORMATION CONTACT: respondents rely to bring information to
Certification Number (CCN). State Domini Bean, Office of Operations, FDA regarding the development of foods
Medicaid agencies and CMS use the Food and Drug Administration, Three derived from new plant varieties. All
provider’s tax identification number and White Flint North, 10A–12M, 11601 the more reason, the comments said,
NPI or CCN combination in order to Landsdown St., North Bethesda, MD FDA should identify mechanisms by
make payment, validate payment 20852, 301–796–5733, PRAStaff@ which it can better incorporate its
eligibility and detect and prevent fda.hhs.gov. experience over time and, where
duplicate payments for EPs, eligible SUPPLEMENTARY INFORMATION: In possible, implement more efficient,
hospitals and CAHs. Form Number: compliance with 44 U.S.C. 3507, FDA streamlined review processes for those
CMS–10336 (OMB Control Number: has submitted the following proposed products similar to those the Agency
0938–1158); Frequency: Occasionally; collection of information to OMB for has reviewed in the past. The comments
Affected Public: Private sector; Number review and clearance. recommended FDA compare efficiencies
of Respondents: 214,694; Total Annual with a process at the U.S. Department of
Responses: 214,694; Total Annual Guidance on Consultation Procedures:
Foods Derived From New Plant Agriculture regarding the review of
Hours: 2,034,740. (For policy questions agricultural biotechnology products. We
regarding this collection contact Steven Varieties
appreciate this suggestion. FDA strives
Johnson at (410) 786–3332). OMB Control Number 0910–0704— to allocate its limited resources in ways
Dated: March 22, 2018. Extension that maximize protection to the public
William N. Parham, III, This information collection supports health and facilitate compliance with
Director, Paperwork Reduction Staff, Office the above captioned Agency guidance existing regulatory requirements
of Strategic Operations and Regulatory document. FDA recommends that implemented to do so. We also look for
Affairs. producers who use biotechnology in the ways in which we might coordinate our
[FR Doc. 2018–06081 Filed 3–26–18; 8:45 am] manufacture or development of foods efforts with those by other agencies who
BILLING CODE 4120–01–P and food ingredients work cooperatively share these objectives.
with FDA to ensure that products Both comments also included the
derived through biotechnology are safe suggestion that FDA develop a less
DEPARTMENT OF HEALTH AND and comply with all applicable legal redundant review process (such as
HUMAN SERVICES requirements and has instituted a reciprocity if no material differences are
voluntary consultation process with
Food and Drug Administration identified) that better coordinates
industry. To facilitate this process the
expertise across the Center for Food
Agency has issued a guidance entitled,
[Docket No. FDA–2010–D–0073] Safety and Nutrition (CFSAN) and the
‘‘Guidance on Consultation Procedures:
Foods Derived From New Plant Center for Veterinary Medicine (CVM)
Agency Information Collection Varieties,’’ which is available on our into a single, efficient review. We
Activities; Submission for Office of website at https://www.fda.gov/ appreciate this suggestion as well and,
Management and Budget Review; FoodGuidances. The guidance describes as discussed in the guidance, note the
Comment Request; Guidance on FDA’s consultation process for the following:
Consultation Procedures: Foods evaluation of information on new plant [FDA’s] Office of Premarket Approval
Derived From New Plant Varieties varieties provided by developers. The of the CFSAN and the Office of
AGENCY: Food and Drug Administration, Agency believes this consultation Surveillance and Compliance of the
HHS. process will help ensure that human CVM have established a Biotechnology
ACTION: Notice. food and animal feed safety issues or Evaluation Team (BET) to facilitate, and
other regulatory issues (e.g., labeling) to ensure consistency in the process by
SUMMARY: The Food and Drug are resolved prior to commercial which firms consult under the 1992
Administration (FDA) is announcing distribution. Additionally, such policy and inform FDA regarding the
that a proposed collection of communication will help to ensure that marketing of bioengineered foods and
information has been submitted to the any potential food safety issues food ingredients derived from new plant
Office of Management and Budget regarding a new plant variety are varieties including those developed
(OMB) for review and clearance under resolved during development, and will using rDNA techniques. The BET
the Paperwork Reduction Act of 1995 help to ensure that all market entry oversees the consultation process,
(PRA). decisions by the industry are made identifies regulatory and scientific
consistently and in full compliance with issues that need to be addressed, and
DATES: Fax written comments on the
the standards of the Federal Food, Drug, once all relevant issues have been
collection of information by April 26,
and Cosmetic Act (FD&C Act). adequately addressed, brings the
2018. In the Federal Register of December consultation to closure.
ADDRESSES: To ensure that comments on 13, 2017 (82 FR 58619), we published a
the information collection are received, 60-day notice requesting public At the same time, we have shared the
OMB recommends that written comment on the proposed extension of comments received in response to this
comments be faxed to the Office of this collection of information. Two notice under the PRA with the BET.
Information and Regulatory Affairs, comments were received in response to Consistent with our Good Guidance
OMB, Attn: FDA Desk Officer, Fax: 202– the notice. Overall, the comments Practice regulations (21 CFR 10.115),
FDA welcomes comments on our
amozie on DSK30RV082PROD with NOTICES
395–7285, or emailed to oira_ supported FDA’s need for the
submission@omb.eop.gov. All information collection and neither guidance documents at any time.
comments should be identified with the comment suggested revising our In consideration of these comments,
OMB control number 0910–0704. Also estimate of the associated burden. we have retained the currently approved
include the FDA docket number found However, both comments reminded us burden estimated associated with the
in brackets in the heading of this that significant resources were invested information collection, which is as
document. into developing data upon which follows:
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![Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices 13133
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of responses Total
Activity FDA form No. annual burden per
respondents per hours
responses response
respondent
Initial consultation .................................... None 20 2 40 4 160
Final consultation ..................................... 3665 12 1 12 150 1,800
Total .................................................. ........................ ........................ ........................ ........................ ........................ 1,960
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate is based on the conducted about the bioengineered food Committee provides advice on
information collection activities that is intended to be introduced into scientific, technical, and medical issues
discussed below. commercial distribution. FDA evaluates concerning human drug compounding
the submission to ensure that all under the Federal Food, Drug, and
Initial Consultations
potential safety and regulatory questions Cosmetic Act (FD&C Act), and, as
Initial consultations are generally a have been addressed. FDA has required, any other product for which
one-time burden, although a developer developed a form that prompts a FDA has regulatory responsibility, and
might return more than once to discuss developer to include certain elements in makes appropriate recommendations to
additional issues before submitting a the final consultation in a standard the Commissioner of Food and Drugs.
final consultation. As noted in the format: Form FDA 3665 entitled, ‘‘Final FDA seeks to include the views of
guidance, FDA encourages developers to Consultation for Food Derived From a women and men, members of all racial
consult early in the development phase New Plant Variety (Biotechnology Final and ethnic groups, and individuals with
of their products, and as often as Consultation).’’ The form, and elements and without disabilities on its advisory
necessary. Historically, firms that would be prepared as attachments committees and, therefore, encourages
developing a new bioengineered plant to the form, can be submitted in nominations of appropriately qualified
variety intended for food use have electronic format. candidates from these groups.
generally initiated consultation with We base our estimate of the average DATES: Nominations received on or
FDA early in the process of developing time to prepare a submission on before May 29, 2018, will be given first
such a variety, even though there is no informal contact with firms that made consideration for membership on the
legal obligation for such consultation. one or more biotechnology consultation Pharmacy Compounding Advisory
These consultations have served to submission under the voluntary Committee. Nominations received after
make FDA aware of foods and food biotechnology consultation process. As May 29, 2018, will be considered for
ingredients before these products are such, we estimate the average time to nominations to the Committee as later
distributed commercially, and have prepare a submission for final vacancies occur.
provided FDA with the information consultation to be 150 hours. ADDRESSES: All nominations for
necessary to address any potential
Dated: March 21, 2018. membership should be sent
questions regarding the safety, labeling,
Leslie Kux, electronically by logging into the FDA
or regulatory status of the food or food
Advisory Nomination Portal: https://
ingredient. As such, these consultations Associate Commissioner for Policy.
www.accessdata.fda.gov/scripts/
have provided assistance to both [FR Doc. 2018–06069 Filed 3–26–18; 8:45 am]
FACTRSPortal/FACTRS/index.cfm or by
industry and the Agency in exercising BILLING CODE 4164–01–P
mail to Advisory Committee Oversight
their mutual responsibilities under the
and Management Staff, Food and Drug
FD&C Act.
FDA estimates that CVM and CFSAN Administration, 10903 New Hampshire
DEPARTMENT OF HEALTH AND
jointly received an average of 40 initial Ave., Bldg. 32, Rm. 5103, Silver Spring,
HUMAN SERVICES
consultations per year in the last 3 years MD 20993–0002.
via telephone, email, or written letter. Food and Drug Administration FOR FURTHER INFORMATION CONTACT:
Based on this information, we expect to Regarding all nomination questions for
[Docket No. FDA–2018–N–0965] membership, the primary contact is:
receive no more than 40 annually in the
next 3 years. Cindy Chee, Center for Drug Evaluation
Request for Nominations for Voting
and Research, Food and Drug
Final Consultations Members on a Public Advisory
Administration, 10903 New Hampshire
Committee; Pharmacy Compounding
Final consultations are a one-time Ave., Bldg. 31, Rm. 2417, Silver Spring,
Advisory Committee
burden. At some stage in the process of MD 20993–0002; 301–796–9001, Fax:
research and development, a developer AGENCY: Food and Drug Administration, 301–847–8533, email: PCAC@
will have accumulated the information HHS. fda.hhs.gov.
that the developer believes is adequate ACTION: Notice. Information about becoming a
to ensure that food derived from the member on an FDA advisory committee
new plant variety is safe and that it SUMMARY: The Food and Drug can also be obtained by visiting FDA’s
amozie on DSK30RV082PROD with NOTICES
demonstrates compliance with the Administration (FDA) is requesting website by using the following link:
relevant provisions of the FD&C Act. nominations for members to serve on https://www.fda.gov/
The developer will then be in a position the Pharmacy Compounding Advisory AdvisoryCommittees/default.htm.
to conclude any ongoing consultation Committee (Committee), Division of SUPPLEMENTARY INFORMATION: FDA is
with FDA. The developer submits to Advisory Committee Consultant requesting nominations for voting
FDA a summary of the safety and Management, Center for Drug members on the Pharmacy
nutritional assessment that has been Evaluation and Research. The Compounding Advisory Committee.
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Document Created: 2018-03-27 01:26:43
Document Modified: 2018-03-27 01:26:43
| 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 April 26, 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 | 83 FR 13132 |
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