Compliance With and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations; Draft Guidance for Industry; Availability, 7751-7753 [2017-01128]

Download as PDF Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules this chapter, the exchange determines that a person has violated exchange rules relating to decorum or attire, or timely submission of accurate records required for clearing or verifying each day’s transactions or other similar activities; or (4) The person against whom the action is taken has consented to the penalty to be imposed and to the timing of its effectiveness. (b) Notice of early effective date. If the exchange determines in accordance with paragraph (a)(1) of this section that a disciplinary action will become effective prior to the expiration of fifteen days after written notice thereof, it must notify the person disciplined in writing, either personally or by email to the person’s last known email address, stating the reasons for the determination. The exchange must also immediately notify the Commission by email to secretary@cftc.gov. Where notice is delivered by email, the time within which the person so notified may file a petition for stay pursuant to § 9.24(a)(2) will be increased by one day. ■ 12. Revise § 9.13 to read as follows: § 9.13 Publication of notice. Whenever an exchange suspends, expels or otherwise disciplines, or denies any person access to the exchange, it must make public its findings by disclosing at least the information contained in the notice required by § 9.11(b). An exchange must make such findings public as soon as the disciplinary action or access denial action becomes effective in accordance with the provisions of § 9.12 by posting a notice on its Web site to which its members and the public regularly have access. Such notice must be maintained and readily available on the exchange’s Web site. ■ 13. In § 9.24, revise paragraph (a)(2) to read as follows: mstockstill on DSK3G9T082PROD with PROPOSALS § 9.24 Petition for stay pending review. (a) * * * (2) Within ten days after a notice of summary action has been delivered in accordance with § 9.12(b) to a person who is the subject of a summary action permitted by part 37, appendix B, Core Principle 2, paragraph (a)(14) or part 38, appendix B, Core Principle 13, paragraph (a)(7) (emergency disciplinary actions) of this chapter, that person may petition the Commission to stay the effectiveness of the summary action pending completion of the exchange proceeding. * * * * * ■ 14. Revise § 9.31 to read as follows: VerDate Sep<11>2014 18:58 Jan 19, 2017 Jkt 241001 § 9.31 Commission review of disciplinary or access denial action on its own motion. 7751 Appendix to Amendments to Parts 3 and 9 of the Commodity Futures (a) Request for additional information. Trading Commission’s Rules— Commission Voting Summary Where a person disciplined or denied On this matter, Chairman Massad and access has not appealed the exchange Commissioners Bowen and Giancarlo decision to the Commission, upon voted in the affirmative. No review of the notice specified in § 9.11, Commissioner voted in the negative. the Division of Market Oversight or the [FR Doc. 2017–01232 Filed 1–19–17; 8:45 am] Division of Swap Dealer and Intermediary Oversight may request that BILLING CODE 6351–01–P the exchange file with the Division the record of the exchange proceeding, or designated portions of the record, a brief DEPARTMENT OF HEALTH AND statement of the evidence and testimony HUMAN SERVICES adduced to support the exchange’s Food and Drug Administration findings that a rule or rules of the exchange were violated and such 21 CFR Parts 11, 16, and 112 recordings, transcripts and other [Docket No. FDA–2017–D–0175] documents applicable to the particular exchange proceeding as the Division Compliance With and may specify. The exchange must Recommendations for Implementation promptly advise the person who is the of the Standards for the Growing, subject of the disciplinary or access Harvesting, Packing, and Holding of denial action of the Division’s request. Produce for Human Consumption for Within thirty days after service of the Sprout Operations; Draft Guidance for Division’s request, the exchange must Industry; Availability file the information requested with the Division in the manner requested by the AGENCY: Food and Drug Administration, Division and, upon request, deliver that HHS. ACTION: Notification of availability. information to the person who is the subject of the disciplinary or access SUMMARY: The Food and Drug denial action. Delivery to the person Administration (FDA or we) is who is the subject of the disciplinary or announcing the availability of a draft access denial action must be in the guidance for industry entitled manner prescribed by § 9.11(c). A ‘‘Compliance with and person subject to the disciplinary action Recommendations for Implementation or access denial action requesting a of the Standards for the Growing, copy of the information furnished to the Harvesting, Packing, and Holding of Division must, if the exchange rules so Produce for Human Consumption for provide, agree to pay the exchange Sprout Operations.’’ The draft guidance, reasonable fees for printing the copy. when finalized, will help sprout operations subject to FDA’s final rule (b) Review on motion of the entitled ‘‘Standards for the Growing, Commission. The Commission may Harvesting, Packing, and Holding of institute review of an exchange Produce for Human Consumption’’ (the disciplinary or access denial action on Produce Safety Rule), and primarily its own motion. Other than in focuses on assisting such operations in extraordinary circumstances, such review will be initiated within 180 days complying with the sprout-specific after the NFA has received the notice of requirements in Subpart M (Sprouts) of the Produce Safety Rule. The draft exchange action provided for in § 9.11. guidance also includes limited If the Commission should institute discussion on certain other applicable review on its own motion, it will issue requirements of the Produce Safety an order permitting the person who is Rule. This draft guidance may also be the subject of the disciplinary or access useful to sprout operations that are not denial action an opportunity to file an subject to the Produce Safety Rule that appropriate submission, and the voluntarily choose to follow the exchange an opportunity to file a reply standards established by the rule. thereto. DATES: Although you can comment on any guidance at any time (see 21 CFR Issued in Washington, DC, on January 13, 10.115(g)(5)), to ensure that the Agency 2017, by the Commission. considers your comment on this draft Christopher J. Kirkpatrick, guidance before it begins work on the Secretary of the Commission. final version of the guidance, submit Note: The following appendix will not either electronic or written comments appear in the Code of Federal Regulations. on the draft guidance by July 24, 2017. PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 E:\FR\FM\23JAP1.SGM 23JAP1 7752 ADDRESSES: Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules You may submit comments as follows: mstockstill on DSK3G9T082PROD with PROPOSALS 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 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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–D–0175 for ‘‘Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 VerDate Sep<11>2014 18:58 Jan 19, 2017 Jkt 241001 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.’’ We will review this copy, including the claimed confidential information, in our 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 Division of Dockets Management. 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Division of Produce Safety, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1600. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740–3835, 240– 402–1636. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 ‘‘Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. The draft guidance for industry is intended to explain our current thinking on how to comply with the requirements for the safe growing, harvesting, packing and holding of produce under 21 CFR part 112, focusing on subparts impacting sprout operations covered by Subpart M. Topics discussed in the draft guidance include: • General Sprout Production; • Buildings, Tools, and Equipment; • Cleaning and Sanitizing; • Agricultural Water in Sprouting Operations; • Seeds for Sprouting; • Sampling and Testing of Spent Sprout Irrigation Water or Sprouts; • Environmental Monitoring; and • Recordkeeping. FDA welcomes comments on any aspect of this draft guidance. We are particularly interested in receiving information about the types of seed or bean treatments that have been used by sprout operations and/or seed suppliers, as well as their feasibility of use, cost, impact on germination; scientific information related to the effectiveness in reducing or eliminating microorganisms of public health significance; and any variability in treatment effectiveness based on seed type. FDA has developed a risk assessment model to evaluate the public health impact of seed treatment and testing of spent irrigation water in a sprout production system and anticipates making it available in the near future, following peer review. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (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 E:\FR\FM\23JAP1.SGM 23JAP1 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules 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 publish notice in the Federal Register soliciting public comment on each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, we will publish a 60-day notice on the proposed collection of information in a future issue of the Federal Register. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: January 12, 2017. Leslie Kux, Associate Commissioner for Policy. reference to temporary regulation at 81 FR 89022, December 9, 2016, are still being accepted and must be received by March 9, 2017. Send submissions to CC:PA:LPD:PR (REG–133353–16), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG–133353– 16), Courier’s desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224, or sent electronically, via the Federal eRulemaking Portal at www.regulations.gov (IRS REG–133353– 16). ADDRESSES: SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P Background Need for Correction DEPARTMENT OF THE TREASURY [REG–133353–16] As published, the notice of proposed rulemaking by cross-reference to temporary regulation (REG–133353–16) contains errors that are misleading and are in need of clarification. RIN 1545–BN63 Correction to Publication Disclosures of Return Information Reflected on Returns to Officers and Employees of the Department of Commerce for Certain Statistical Purposes and Related Activities; Correction Accordingly, the notice of proposed rulemaking by cross-reference to temporary regulation, that is the subject of FR Doc. 2016–29490, is corrected as follows: 1. On page 89022, in the preamble, second column, second line from the top of column, the language ‘‘CC:PA:LPD:PR (REG–133533–16), Room’’ is corrected to read ‘‘CC:PA:LPD:PR (REG–133353–16), Room’’. 2. On page 89022, in the preamble, second column, eighth line from the top of column, the language ‘‘4 p.m. to CC:PA:LPD:PR (REG–133533–’’ is corrected to read ‘‘4 p.m. to CC:PA:LPD:PR (REG–133353–’’. 3. On page 89022, in the preamble, second column, sixth line from the bottom of ADDRESSES caption, the language ‘‘Service, 1111 Constitutional Avenue’’ is corrected to read ‘‘Service, 1111 Constitution Avenue’’. Internal Revenue Service 26 CFR Part 1 Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking by cross-reference to temporary regulation; correction. AGENCY: This document contains corrections to a notice of proposed rulemaking by cross-reference to temporary regulation (REG–133353–16) that was published in the Federal Register on Friday, December 9, 2016. The proposed regulations authorize the disclosure of specified return information to the Census Bureau (Bureau) for purposes of structuring the censuses and national economic accounts and conducting related statistical activities authorized by title 13. mstockstill on DSK3G9T082PROD with PROPOSALS SUMMARY: Written or electronic comments and request for public hearing for the notice of proposed rulemaking by cross- DATES: VerDate Sep<11>2014 18:58 Jan 19, 2017 Jkt 241001 § 301.6103(j)(1)–1 [Corrected] 4. On page 89023, first column, third line of paragraph (e), the language ‘‘(b)(3)(v), (b)(3)(xxv), (b)(3)(xxv) PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 through’’ is corrected to read ‘‘(b)(3)(v), (b)(3)(xxv) through’’. Martin V. Franks, Branch Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administrative). [FR Doc. 2017–00946 Filed 1–19–17; 8:45 am] BILLING CODE 4830–01–P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Parts 24 and 27 [Docket No. TTB–2016–0014; Notice No. 168; Re: T.D. TTB–147] RIN 1513–AC31 The notice of proposed rulemaking by cross-reference to temporary regulation that is the subject of this document is under section 6103(j)(1)(A) of the Internal Revenue Code. [FR Doc. 2017–01128 Filed 1–19–17; 8:45 am] 7753 Implementation of Statutory Amendments Requiring the Modification of the Definition of Hard Cider Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Notice of proposed rulemaking; cross-reference to temporary rule. AGENCY: Elsewhere in this issue of the Federal Register, by means of a temporary rule, the Alcohol and Tobacco Tax and Trade Bureau (TTB) implements changes made to the definition of ‘‘hard cider’’ in the Internal Revenue Code of 1986 by the Protecting Americans from Tax Hikes Act of 2015. The modified definition broadens the range of wines eligible for the hard cider tax rate. TTB is amending its regulations to reflect the modified definition of hard cider effective for products removed on or after January 1, 2017, and to set forth new labeling requirements to identify products to which the hard cider tax rate applies. The new labeling requirements include both a one-year transitional rule and a new labeling requirement that takes effect for products removed on or after January 1, 2018. The text of the regulations in that temporary rule published elsewhere in this issue of the Federal Register serves as the text of the proposed regulations. DATES: Comments must be received on or before March 24, 2017. ADDRESSES: Please send your comments on this document to one of the following addresses: • Internet: https:// www.regulations.gov (via the online comment form for this document as posted within Docket No. TTB–2016– 0014 at ‘‘Regulations.gov,’’ the Federal e-rulemaking portal); SUMMARY: E:\FR\FM\23JAP1.SGM 23JAP1

Agencies

[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Proposed Rules]
[Pages 7751-7753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01128]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 16, and 112

[Docket No. FDA-2017-D-0175]


Compliance With and Recommendations for Implementation of the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption for Sprout Operations; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Compliance 
with and Recommendations for Implementation of the Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption for Sprout Operations.'' The draft guidance, when 
finalized, will help sprout operations subject to FDA's final rule 
entitled ``Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption'' (the Produce Safety Rule), and 
primarily focuses on assisting such operations in complying with the 
sprout-specific requirements in Subpart M (Sprouts) of the Produce 
Safety Rule. The draft guidance also includes limited discussion on 
certain other applicable requirements of the Produce Safety Rule. This 
draft guidance may also be useful to sprout operations that are not 
subject to the Produce Safety Rule that voluntarily choose to follow 
the standards established by the rule.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 24, 2017.

[[Page 7752]]


ADDRESSES: You may submit comments as follows:

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 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-D-0175 for ``Compliance with and Recommendations for 
Implementation of the Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption for Sprout Operations.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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.'' We will review this copy, 
including the claimed confidential information, in our 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 
Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Produce Safety, Center for Food Safety and Applied 
Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1600. Send one self-addressed adhesive 
label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety 
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740-3835, 240-402-1636.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Compliance with and Recommendations for Implementation of 
the Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption for Sprout Operations.'' We are issuing 
the draft guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent our current thinking on this topic. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.
    The draft guidance for industry is intended to explain our current 
thinking on how to comply with the requirements for the safe growing, 
harvesting, packing and holding of produce under 21 CFR part 112, 
focusing on subparts impacting sprout operations covered by Subpart M. 
Topics discussed in the draft guidance include:
     General Sprout Production;
     Buildings, Tools, and Equipment;
     Cleaning and Sanitizing;
     Agricultural Water in Sprouting Operations;
     Seeds for Sprouting;
     Sampling and Testing of Spent Sprout Irrigation Water or 
Sprouts;
     Environmental Monitoring; and
     Recordkeeping.
    FDA welcomes comments on any aspect of this draft guidance. We are 
particularly interested in receiving information about the types of 
seed or bean treatments that have been used by sprout operations and/or 
seed suppliers, as well as their feasibility of use, cost, impact on 
germination; scientific information related to the effectiveness in 
reducing or eliminating microorganisms of public health significance; 
and any variability in treatment effectiveness based on seed type.
    FDA has developed a risk assessment model to evaluate the public 
health impact of seed treatment and testing of spent irrigation water 
in a sprout production system and anticipates making it available in 
the near future, following peer review.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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

[[Page 7753]]

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 publish notice in the Federal Register 
soliciting public comment on each proposed collection of information 
before submitting the collection to OMB for approval. To comply with 
this requirement, we will publish a 60-day notice on the proposed 
collection of information in a future issue of the Federal Register.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01128 Filed 1-19-17; 8:45 am]
 BILLING CODE 4164-01-P
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