82 FR 58619 - Agency Information Collection Activities; Proposed Collection; 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 82, Issue 238 (December 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 238 (December 13, 2017)
| Page Range | 58619-58621 | |
| FR Document | 2017-26794 |
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)] [Notices] [Pages 58619-58621] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26794] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6455] Agency Information Collection Activities; Proposed Collection; 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 or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format. DATES: Submit either electronic or written comments on the collection of information by February 12, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 12, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact [[Page 58620]] information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-6455 for ``Guidance on Consultation Procedures: Foods Derived from New Plant Varieties.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 (the FD&C Act). Since 1992, when FDA issued its ``Statement of Policy: Foods Derived From New Plant Varieties'' (the 1992 policy) (57 FR 22984, May 29, 1992), FDA has encouraged developers of new plant varieties, including those varieties that are developed through biotechnology, to consult with FDA during the plant development process to discuss possible scientific and regulatory issues that might arise. In the 1992 policy, FDA explained that, under the FD&C Act, developers of new foods (in this document food refers to both human food and animal feed) have a responsibility to ensure that the foods they offer to consumers are safe and in compliance with all requirements of the FD&C Act (57 FR 22984 at 22985). Description of Respondents: Respondents to this collection of information include developers of new plant varieties intended for food use. [[Page 58621]] FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- No. of Average Activity FDA Form No. No. 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. We have retained the currently approved burden estimate for this information collection and discuss the information collection activities 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 its Center for Veterinary Medicine and its Center for Food Safety and Applied Nutrition 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: December 5, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26794 Filed 12-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices 58619
Recommendations.’’ This draft guidance the draft guidance have been approved SUMMARY: The Food and Drug
is intended to convey to drug by OMB under the following control Administration (FDA or Agency) is
manufacturers FDA’s recommendations numbers: announcing an opportunity for public
on how certain drug products should be OMB control number 0910–0001: comment on the proposed collection of
labeled regarding gluten, a matter of Submitting to FDA labeling in NDAs certain information by the Agency.
interest to individuals with celiac and ANDAs, including amendments to Under the Paperwork Reduction Act of
disease. Some individuals with celiac pending NDAs and ANDAs, 1995 (PRA), Federal Agencies are
disease have faced difficulty when supplements to approved NDAs and required to publish notice in the
trying to determine whether specific ANDAs, and annual reports; OMB Federal Register concerning each
drug products contain gluten. control number 0910–0572: Designing, proposed collection of information,
Confronted by uncertainty, some testing, and revising prescription drug including each proposed extension of an
patients may forego important product labeling; OMB control number existing collection of information, and
medication rather than risk an adverse 0910–0340: Designing, testing, and to allow 60 days for public comment in
reaction to gluten. Thus, even if gluten revising Drug Facts labeling for OTC response to the notice. This notice
is not present at levels that would harm drugs, including submitting labeling to solicits comments on the information
a typical individual with celiac disease, FDA for OTC monograph drugs; OMB collection provisions of FDA’s
that individual may be harmed through control number 0910–0139: consultation procedures for foods
uncertainty and lack of information. Recordkeeping requirements in CGMPs; derived from new plant varieties,
Celiac disease is an immune-based OMB control number 0910–0393: including the information collection
reaction to dietary gluten that primarily Preparing and revising Medication provisions in the guidance entitled,
affects the small intestine in susceptible Guides; and OMB control number 0910– ‘‘Guidance on Consultation Procedures:
individuals; unmanaged celiac disease 0338: Submitting to FDA labeling in Foods Derived From New Plant
can lead to serious health BLAs, including amendments to Varieties,’’ and in Form FDA 3665
complications. Approximately 1 percent pending BLAs, supplements to entitled, ‘‘Final Consultation For Food
of the U.S. population has celiac disease approved BLAs, and annual reports. Derived From a New Plant Variety
(Binder, 2015, ‘‘Disorders of The recommended labeling statement (Biotechnology Final Consultation),’’
Absorption,’’ in Harrison’s Principles of in this draft guidance, ‘‘Contains no which developers may use to prepare
Internal Medicine, 19th ed.). It is ingredient made from a gluten- the final consultation in a standard
characterized by ongoing inflammation containing grain (wheat, barley, or rye)’’ format.
of part of the lining of the small is information provided by FDA to
intestine that generally heals if foods DATES: Submit either electronic or
applicants and manufacturers for written comments on the collection of
containing gluten are excluded from the disclosure to the public and therefore
diet and returns if they are information by February 12, 2018.
does not constitute a collection of ADDRESSES: You may submit comments
reintroduced. This guidance encourages information under 5 CFR 1320.3(c)(2).
drug manufacturers to have accurate as follows. Please note that late,
information about their products’ gluten III. Electronic Access untimely filed comments will not be
content available so they can respond to considered. Electronic comments must
Persons with access to the internet
questions from consumers and health be submitted on or before February 12,
may obtain the draft guidance at either
care professionals. Manufacturers 2018. The https://www.regulations.gov
https://www.fda.gov/Drugs/Guidance
should pay attention to possible sources electronic filing system will accept
ComplianceRegulatoryInformation/
of gluten in their products, consider comments until midnight Eastern Time
Guidances/default.htm, https://
specifications when appropriate, and at the end of February 12, 2018.
www.fda.gov/BiologicsBloodVaccines/
consider the impact of changes in Comments received by mail/hand
GuidanceComplianceRegulatory
ingredient sources or formulations on delivery/courier (for written/paper
Information/default.htm, or https://
gluten content. submissions) will be considered timely
www.regulations.gov.
This draft guidance is being issued if they are postmarked or the delivery
consistent with FDA’s good guidance Dated: December 7, 2017. service acceptance receipt is on or
practices regulation (21 CFR 10.115). Leslie Kux, before that date.
The draft guidance, when finalized, will Associate Commissioner for Policy.
Electronic Submissions
represent the current thinking of FDA [FR Doc. 2017–26828 Filed 12–12–17; 8:45 am]
on Gluten in Drug Products and BILLING CODE 4164–01–P
Submit electronic comments in the
Associated Labeling Recommendations. following way:
It does not establish any rights for any • Federal eRulemaking Portal:
person and is not binding on FDA or the DEPARTMENT OF HEALTH AND https://www.regulations.gov. Follow the
public. You can use an alternative HUMAN SERVICES instructions for submitting comments.
approach if it satisfies the requirements Comments submitted electronically,
of the applicable statutes and Food and Drug Administration including attachments, to https://
regulations. This guidance is not subject www.regulations.gov will be posted to
to Executive Order 12866. [Docket No. FDA–2017–N–6455] the docket unchanged. Because your
comment will be made public, you are
II. The Paperwork Reduction Act of Agency Information Collection solely responsible for ensuring that your
1995 Activities; Proposed Collection; comment does not include any
sradovich on DSK3GMQ082PROD with NOTICES
This draft guidance refers to Comment Request; Guidance on confidential information that you or a
previously approved collections of Consultation Procedures: Foods third party may not wish to be posted,
information that are subject to review by Derived From New Plant Varieties such as medical information, your or
the Office of Management and Budget AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
(OMB) under the Paperwork Reduction HHS. confidential business information, such
Act of 1995 (44 U.S.C. 3501–3520). The as a manufacturing process. Please note
ACTION: Notice.
collections of information discussed in that if you include your name, contact
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![Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices 58621
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of Average
No. of responses Total annual
Activity FDA Form No. burden per Total hours
respondents per 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.
We have retained the currently relevant provisions of the FD&C Act. DEPARTMENT OF HEALTH AND
approved burden estimate for this The developer will then be in a position HUMAN SERVICES
information collection and discuss the to conclude any ongoing consultation
information collection activities below. with FDA. The developer submits to Food and Drug Administration
Initial Consultations FDA a summary of the safety and
nutritional assessment that has been [Docket No. FDA–2014–N–0345]
Initial consultations are generally a conducted about the bioengineered food
one-time burden, although a developer Agency Information Collection
that is intended to be introduced into
might return more than once to discuss Activities; Submission for Office of
commercial distribution. FDA evaluates
additional issues before submitting a Management and Budget Review;
final consultation. As noted in the the submission to ensure that all Comment Request; Data To Support
guidance, FDA encourages developers to potential safety and regulatory questions Drug Product Communications as
consult early in the development phase have been addressed. FDA has Used by the Food and Drug
of their products, and as often as developed a form that prompts a Administration
necessary. Historically, firms developer to include certain elements in
developing a new bioengineered plant the final consultation in a standard AGENCY: Food and Drug Administration,
variety intended for food use have format: Form FDA 3665 entitled, ‘‘Final HHS.
generally initiated consultation with Consultation for Food Derived From a ACTION: Notice.
FDA early in the process of developing New Plant Variety (Biotechnology Final
Consultation).’’ The form, and elements SUMMARY: The Food and Drug
such a variety, even though there is no
that would be prepared as attachments Administration (FDA) is announcing
legal obligation for such consultation.
that a proposed collection of
These consultations have served to to the form, can be submitted in
information has been submitted to the
make FDA aware of foods and food electronic format.
Office of Management and Budget
ingredients before these products are We base our estimate of the average (OMB) for review and clearance under
distributed commercially, and have time to prepare a submission on the Paperwork Reduction Act of 1995.
provided FDA with the information informal contact with firms that made
necessary to address any potential DATES: Fax written comments on the
one or more biotechnology consultation collection of information by January 12,
questions regarding the safety, labeling,
submission under the voluntary 2018.
or regulatory status of the food or food
ingredient. As such, these consultations biotechnology consultation process. As ADDRESSES: To ensure that comments on
have provided assistance to both such, we estimate the average time to the information collection are received,
industry and the Agency in exercising prepare a submission for final OMB recommends that written
their mutual responsibilities under the consultation to be 150 hours. comments be faxed to the Office of
FD&C Act. Dated: December 5, 2017. Information and Regulatory Affairs,
FDA estimates that its Center for Leslie Kux, OMB, Attn: FDA Desk Officer, Fax: 202–
Veterinary Medicine and its Center for 395–7285, or emailed to oira_
Associate Commissioner for Policy.
Food Safety and Applied Nutrition submission@omb.eop.gov. All
[FR Doc. 2017–26794 Filed 12–12–17; 8:45 am]
jointly received an average of 40 initial comments should be identified with the
consultations per year in the last 3 years BILLING CODE 4164–01–P OMB control number 0910–0695. Also
via telephone, email, or written letter. include the FDA docket number found
Based on this information, we expect to in brackets in the heading of this
receive no more than 40 annually in the document.
next 3 years. FOR FURTHER INFORMATION CONTACT:
Final Consultations Domini Bean, Office of Operations,
Final consultations are a one-time Food and Drug Administration, Three
sradovich on DSK3GMQ082PROD with NOTICES
burden. At some stage in the process of White Flint North, 10A–12M, 11601
research and development, a developer Landsdown St., North Bethesda, MD
will have accumulated the information 20852, 301–796–7729, PRAStaff@
that the developer believes is adequate fda.hhs.gov.
to ensure that food derived from the SUPPLEMENTARY INFORMATION: In
new plant variety is safe and that it compliance with 44 U.S.C. 3507, FDA
demonstrates compliance with the has submitted the following proposed
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Document Created: 2017-12-13 01:24:04
Document Modified: 2017-12-13 01:24:04
| 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 | Submit either electronic or written comments on the collection of information by February 12, 2018. | |
| Contact | Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 58619 |
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