82 FR 37815 - Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 155 (August 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 155 (August 14, 2017)
| Page Range | 37815-37817 | |
| FR Document | 2017-17118 |
[Federal Register Volume 82, Number 155 (Monday, August 14, 2017)] [Rules and Regulations] [Pages 37815-37817] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17118] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 133 [Docket No. FDA-2017-D-4713] Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: 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 guidance for industry entitled ``Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry.'' The guidance advises manufacturers who wish to use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF nonfat milk) in the production of standardized cheeses and related cheese products that, pending completion of a rulemaking regarding the use of UF milk in the production of these products, we intend to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products. We also intend to exercise enforcement discretion regarding the declaration of ingredients in the labeling of standardized cheeses and related cheese products when fluid UF milk and fluid UF nonfat milk are used as ingredients. DATES: The announcement of the guidance is published in the Federal Register on August 14, 2017. Submit either electronic or written comments on FDA guidance at any time. 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): 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-D-4713 for ``Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry.'' 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 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.'' 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 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 [[Page 37816]] Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Terri Wenger, Center for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2373. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ``Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry.'' We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA 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. Our regulations specify the standards of identity for cheeses and related cheese products in part 133 (21 CFR part 133). The general provisions within part 133, in part, define ``milk'' and ``nonfat milk'' that may be used in the manufacture of cheeses and related cheese products. The definitions for ``milk'' and ``nonfat milk'' in Sec. 133.3(a) and (b), respectively, list different forms of milk and nonfat milk, including concentrated, reconstituted, and dried forms, that may be used in the making of cheeses and related cheese products. However, fluid or dried filtered forms of milk obtained through mechanical filtration of milk or nonfat milk are not included within these definitions. Therefore, while current regulations permit the use of concentrated, reconstituted, and dried forms of milk and nonfat milk as basic dairy ingredients (i.e., the only difference in these ingredients is the amount of water), they do not provide for the use of fluid or dried filtered milk or fluid or dried filtered nonfat milk as basic dairy ingredients in standardized cheeses and related cheese products. Mechanical filtration technologies available for milk processing include ultrafiltration. For purposes of this guidance, we consider filtration to be a process whereby milk is passed over a series of semipermeable membranes with varying pore sizes. Ultrafiltration retains macromolecules and particles larger than about 0.001-0.02 micrometers. In dairy processing, ultrafiltration is typically used to retain all protein components of milk, including casein and whey proteins, while some of the lactose, minerals, and water soluble vitamins present in milk are lost along with water. For purposes of the guidance, UF milk means raw or pasteurized milk that is passed over one or more semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the casein::whey protein ratio of the milk and resulting in a liquid product. UF nonfat milk is defined similarly, except that raw or pasteurized nonfat milk is used. In the Federal Register of October 19, 2005 (70 FR 60751), we issued a proposed rule that would amend our regulations to provide for the use of fluid UF milk in the manufacture of standardized cheeses and related cheese products. We tentatively concluded that the proposed rule, if finalized, would promote honesty and fair dealing in the interest of consumers and, to the extent practicable, achieve consistency with existing international standards of identity for cheeses and related cheese products. While we have not completed the rulemaking as of August 2017, we are aware of issues regarding UF milk in the United States. In brief, due to recent developments in the export market, the United States dairy industry is experiencing an oversupply of and pricing challenges with domestically produced UF milk (Refs. 1 and 2). Additionally, we have received requests to exercise enforcement discretion while the rulemaking is pending, in part to mitigate the impact on U.S. companies producing UF milk (Ref. 3). FDA believes that food standards should provide for flexibility in manufacturing procedures and ingredients, provided that the basic nature and essential characteristics of the food are preserved. Given the oversupply of UF milk and the pending rulemaking, through this guidance we are announcing our intent to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products under part 133, in addition to the other required dairy ingredients, provided that the physical, chemical, and organoleptic properties of the cheese or cheese product are not affected. FDA is also announcing its intent to exercise enforcement discretion with respect to the labeling of standardized cheeses and related cheese products, when, in addition to milk or nonfat milk, fluid UF milk or fluid UF nonfat milk is used as an ingredient, but is not declared in the ingredient statement, provided that milk or nonfat milk is declared in the ingredient statement. We are exercising enforcement discretion with respect to the labeling of fluid UF milk and fluid UF nonfat milk in recognition of the costs and logistics involved in label changes; however, we encourage industry to identify these ingredients as ``ultrafiltered milk'' and ``ultrafiltered nonfat milk'' to the extent feasible and appropriate. We intend to exercise enforcement discretion until we have completed a rulemaking process amending our regulations with respect to the issues covered by this guidance, or announce in the Federal Register our determination not to proceed with such a rulemaking. We are issuing this guidance without prior public comment under 21 CFR 10.115(g)(2) because we have determined that prior public participation is not feasible or appropriate, as this guidance implements a temporary enforcement policy to address an oversupply of UF pending the completion of rulemaking regarding the use of UF milk in the production of standardized cheeses and related cheese products. The oversupply of UF milk would be worsened if we deferred exercising of enforcement discretion regarding the matters in the guidance while providing an opportunity for prior public comment. (We also note that, as we stated in the preamble to the 2005 proposed rule, we tentatively conclude that fluid UF milk can be used in standardized cheeses while maintaining the essential characteristics of those cheeses specified in the individual standards of identity in part 133 (see 70 FR 60751 at 60756 through 60757).) However, as with all Agency guidances, the public may comment on the guidance at any time. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the 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. [[Page 37817]] III. References The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Letter from Senator Amy Klobuchar, Senator Al Franken, Representative Collin Peterson, and Representative Tim Walz, to President Donald J. Trump, accessed on the Web at https://www.klobuchar.senate.gov/public/index.cfm/2017/4/klobuchar-franken-peterson-walz-urge-administration-to-support-minnesota-dairy-farmers-through-strong-enforcement-of-our-trade-laws-with-canada. 2. Congressional Research Service, ``New Canadian Dairy Pricing Regime Proves Disruptive for U.S. Milk Producers,'' dated April 20, 2017, accessed on the Web at https://www.everycrsreport.com/reports/IN10692.html. 3. Letter from Michael D. Dykes, D.V.M., President and CEO, International Dairy Foods Association, to Stephen Ostroff, M.D., Deputy Commissioner for Foods and Veterinary Medicine, Food and Drug Administration, dated June 22, 2017. Dated: August 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-17118 Filed 8-11-17; 8:45 am] BILLING CODE 4164-01-P
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times established in advance by a Notice to guidance for industry entitled Management Staff (HFA–305), Food and
Airmen. The effective date and time will ‘‘Ultrafiltered Milk in the Production of Drug Administration, 5630 Fishers
thereafter be continuously published in the Standardized Cheeses and Related Lane, Rm. 1061, Rockville, MD 20852.
Pacific Chart Supplement.
Cheese Products: Guidance for • For written/paper comments
Paragraph 6004 Class E Airspace Areas Industry.’’ The guidance advises submitted to the Dockets Management
Designated as an Extension to a Class D or manufacturers who wish to use Staff, FDA will post your comment, as
Class E Surface Area. ultrafiltered milk (UF milk) or well as any attachments, except for
* * * * * ultrafiltered nonfat milk (UF nonfat information submitted, marked and
AWP HI E4 Hilo, HI [Corrected]
milk) in the production of standardized identified, as confidential, if submitted
cheeses and related cheese products as detailed in ‘‘Instructions.’’
Hilo International Airport, HI that, pending completion of a
(Lat. 19°43′13″ N., long. 155°02′55″ W.) Instructions: All submissions received
Hilo VORTAC
rulemaking regarding the use of UF milk must include the Docket No. FDA–
(Lat. 19°43′17″ N., long. 155°00′39″ W.) in the production of these products, we 2017–D–4713 for ‘‘Ultrafiltered Milk in
That airspace extending upward from the
intend to exercise enforcement the Production of Standardized Cheeses
surface within 3 miles each side of the Hilo discretion regarding the use of fluid UF and Related Cheese Products: Guidance
VORTAC 090° radial, extending from the 4.3- milk and fluid UF nonfat milk in the for Industry.’’ Received comments will
mile radius of Hilo International Airport to production of standardized cheeses and be placed in the docket and, except for
8.7 miles east of the Hilo VORTAC. related cheese products. We also intend those submitted as ‘‘Confidential
Paragraph 6005 Class E Airspace Extending
to exercise enforcement discretion Submissions,’’ publicly viewable at
Upward From 700 Feet or More Above the regarding the declaration of ingredients https://www.regulations.gov or at the
Surface of the Earth. in the labeling of standardized cheeses Dockets Management Staff between 9
* * * * * and related cheese products when fluid a.m. and 4 p.m., Monday through
UF milk and fluid UF nonfat milk are Friday.
AWP HI E5 Hilo, HI [Amended] used as ingredients. • Confidential Submissions—To
Hilo International Airport, HI DATES: The announcement of the submit a comment with confidential
(Lat. 19°43′13″ N., long. 155°02′55″ W.) guidance is published in the Federal
Hilo VORTAC
information that you do not wish to be
Register on August 14, 2017. Submit made publicly available, submit your
(Lat. 19°43′17″ N., long. 155°00′39″ W.) either electronic or written comments
That airspace extending upward from 700
comments only as a written/paper
on FDA guidance at any time. submission. You should submit two
feet above the surface within a 4.3-mile
ADDRESSES: You may submit comments copies total. One copy will include the
radius of Hilo International Airport and
within 3 miles each side of the Hilo VORTAC as follows: information you claim to be confidential
090° radial, extending from the 4.3-mile Electronic Submissions with a heading or cover note that states
radius to 8.7 miles east of the VORTAC and ‘‘THIS DOCUMENT CONTAINS
that airspace extending from the 4.3-mile Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ We
radius to the 7.4-mile radius of the Hilo following way: will review this copy, including the
International Airport extending clockwise • Federal eRulemaking Portal:
from a line 1.8 miles southwest of and
claimed confidential information, in our
https://www.regulations.gov. Follow the
parallel to the Hilo VORTAC 321° radial to consideration of comments. The second
instructions for submitting comments.
a line 3 miles north of and parallel to the copy, which will have the claimed
Comments submitted electronically,
Hilo VORTAC 090° radial. confidential information redacted/
including attachments, to https://
blacked out, will be available for public
Issued in Seattle, Washington, on August 3, www.regulations.gov will be posted to
2017. viewing and posted on https://
the docket unchanged. Because your
www.regulations.gov. Submit both
Byron Chew, comment will be made public, you are
solely responsible for ensuring that your copies to the Dockets Management Staff.
Acting Group Manager, Operations Support
Group, Western Service Center. comment does not include any If you do not wish your name and
confidential information that you or a contact information to be made publicly
[FR Doc. 2017–17004 Filed 8–11–17; 8:45 am]
third party may not wish to be posted, available, you can provide this
BILLING CODE 4910–13–P
such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
DEPARTMENT OF HEALTH AND ‘‘confidential.’’ Any information marked
HUMAN SERVICES as a manufacturing process. Please note
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
information, or other information that except in accordance with 21 CFR 10.20
Food and Drug Administration
identifies you in the body of your and other applicable disclosure law. For
comments, that information will be more information about FDA’s posting
21 CFR Part 133
posted on https://www.regulations.gov. of comments to public dockets, see 80
[Docket No. FDA–2017–D–4713] • If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
Ultrafiltered Milk in the Production of fdsys/pkg/FR-2015-09-18/pdf/2015-
Standardized Cheeses and Related do not wish to be made available to the
public, submit the comment as a 23389.pdf.
Cheese Products: Guidance for Docket: For access to the docket to
Industry; Availability written/paper submission and in the
manner detailed (see ‘‘Written/Paper read background documents or the
sradovich on DSK3GMQ082PROD with RULES
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
HHS. received, go to https://
Written/Paper Submissions www.regulations.gov and insert the
ACTION: Notification of availability.
Submit written/paper submissions as docket number, found in brackets in the
SUMMARY: The Food and Drug follows: heading of this document, into the
Administration (FDA or we) is • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
announcing the availability of a written/paper submissions): Dockets and/or go to the Dockets Management
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![Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Rules and Regulations 37817
III. References section 148 of the Internal Revenue ACTION: Final rule.
The following references are on Code applicable to tax-exempt bonds
display in the Dockets Management and other tax-advantaged bonds issued SUMMARY: The Environmental Protection
Staff (see ADDRESSES) and are available by State and local governments. Agency (EPA) is taking final action to
for viewing by interested persons DATES: This correction is effective approve a revision to the San Joaquin
between 9 a.m. and 4 p.m., Monday August 14, 2017 and applicable July 18, Valley Unified Air Pollution Control
through Friday; they are also available 2016. District (SJVUAPCD or ‘‘the District’’)
electronically at https:// FOR FURTHER INFORMATION CONTACT: portion of the California State
www.regulations.gov. FDA has verified Spence Hanemann at (202) 317–6980 Implementation Plan (SIP). This revised
the Web site addresses, as of the date (not a toll-free number). rule concerns emissions of oxides of
this document publishes in the Federal SUPPLEMENTARY INFORMATION: nitrogen, carbon monoxide, oxides of
Register, but Web sites are subject to Background sulfur, and particulate matter of 10
change over time. microns or less from boilers, steam
1. Letter from Senator Amy Klobuchar, The final regulations (TD 9777) that
generators and process heaters. We are
Senator Al Franken, Representative are the subject of this correction are
approving a local rule that regulates
Collin Peterson, and Representative Tim under section 148 of the Internal
Walz, to President Donald J. Trump, Revenue Code. these emission sources under the Clean
accessed on the Web at https:// Air Act (CAA or the Act).
www.klobuchar.senate.gov/public/ Need for Correction
DATES:This rule will be effective on
index.cfm/2017/4/klobuchar-franken- As published, the final regulations
peterson-walz-urge-administration-to- September 13, 2017.
(TD 9777) contain an error that may
support-minnesota-dairy-farmers- prove to be misleading and are in need ADDRESSES: The EPA has established a
through-strong-enforcement-of-our-trade-
of clarification. docket for this action under Docket ID
laws-with-canada.
2. Congressional Research Service, ‘‘New No. EPA–R09–OAR–2017–0034. All
List of Subjects in 26 CFR Part 1
Canadian Dairy Pricing Regime Proves documents in the docket are listed on
Disruptive for U.S. Milk Producers,’’ Income taxes, Reporting and the http://www.regulations.gov Web
dated April 20, 2017, accessed on the recordkeeping requirements. site. Although listed in the index, some
Web at https://www.everycrsreport.com/ Correction of Publication information is not publicly available,
reports/IN10692.html. e.g., Confidential Business Information
3. Letter from Michael D. Dykes, D.V.M., Accordingly, 26 CFR part 1 is
President and CEO, International Dairy amended by making the following or other information whose disclosure is
Foods Association, to Stephen Ostroff, correcting amendment: restricted by statute. Certain other
M.D., Deputy Commissioner for Foods material, such as copyrighted material,
and Veterinary Medicine, Food and Drug PART 1—INCOME TAXES is not placed on the Internet and will be
Administration, dated June 22, 2017. publicly available only in hard copy
■ Paragraph 1. The authority citation form. Publicly available docket
Dated: August 9, 2017.
for part 1 continues to read in part as materials are available through http://
Anna K. Abram, follows:
Deputy Commissioner for Policy, Planning, www.regulations.gov, or please contact
Legislation, and Analysis. Authority: 26 U.S.C. 7805 * * * the person identified in the FOR FURTHER
[FR Doc. 2017–17118 Filed 8–11–17; 8:45 am] § 1.148–11 [Amended] INFORMATION CONTACT section for
BILLING CODE 4164–01–P additional availability information.
■ Par. 2. Amend § 1.148–11(k)(1) by
adding ‘‘1.148–6(d)(3)(iii)(A);’’ before FOR FURTHER INFORMATION CONTACT:
‘‘1.148–6(d)(4)’’. Nancy Levin, EPA Region IX, (415) 972–
DEPARTMENT OF THE TREASURY 3848, levin.nancy@epa.gov.
Martin V. Franks,
Internal Revenue Service Chief, Publications and Regulations Branch, SUPPLEMENTARY INFORMATION:
Legal Processing Division, Associate Chief Throughout this document, ‘‘we,’’ ‘‘us’’
26 CFR Part 1 Counsel (Procedure and Administration) . and ‘‘our’’ refer to the EPA.
[FR Doc. 2017–17135 Filed 8–11–17; 8:45 am]
[TD 9777] BILLING CODE 4830–01–P
Table of Contents
RIN 1545–BG41; 1545–BH38 I. Proposed Action
II. Public Comments and EPA Responses
Arbitrage Guidance for Tax-Exempt ENVIRONMENTAL PROTECTION III. EPA Action
Bonds; Correction AGENCY IV. Incorporation by Reference
V. Statutory and Executive Order Reviews
AGENCY: Internal Revenue Service (IRS), 40 CFR Part 52
Treasury. I. Proposed Action
[EPA–R09–OAR–2017–0034; FRL–9965–26–
ACTION: Correcting amendment.
Region 9] On March 21, 2017 (82 FR 14496), the
SUMMARY: This document contains a EPA proposed to approve the following
Approval of California Air Plan
correction to final regulations (TD 9777) rule into the California SIP.
Revisions, San Joaquin Valley Unified
that were published in the Federal
Air Pollution Control District
sradovich on DSK3GMQ082PROD with RULES
Register on Monday, July 18, 2016 (81
FR 46582). The final regulations relate AGENCY: Environmental Protection
to the arbitrage restrictions under Agency (EPA).
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Document Created: 2018-10-24 11:52:23
Document Modified: 2018-10-24 11:52:23
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on August 14, 2017. Submit either electronic or written comments on FDA guidance at any time. | |
| Contact | Terri Wenger, Center for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2373. | |
| FR Citation | 82 FR 37815 |
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