83 FR 3447 - Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117 or 507; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 17 (January 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 17 (January 25, 2018)
| Page Range | 3447-3449 | |
| FR Document | 2018-01296 |
[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)] [Proposed Rules] [Pages 3447-3449] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01296] [[Page 3447]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 112, 117, and 507 [Docket No. FDA-2017-D-0397] Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117 or 507; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in Part 117 or 507.'' The draft guidance describes FDA's current thinking on the concept of ``same level of public health protection'' (SLPHP), and FDA's expectations for how an SLPHP evaluation should be conducted and an SLPHP determination should be reached. The draft guidance identifies certain points to consider that a competent authority, a farm, a facility, an importer, or other relevant entity should take into consideration when evaluating whether a measure that is different from that required under (part 112) 21 CFR part 112 or the preventive controls requirements in (part 117 or part 507) 21 CFR part 117 or 507 meets the SLPHP threshold under the foreign supplier verification program (FSVP) regulation (21 CFR part 1, subpart L) or under part 112. DATES: Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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-0397 for ``Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in Part 117 or 507.'' 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.'' 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. 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: Ritu Nalubola, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3252. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ``Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in Part 117 or 507.'' We are issuing the draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for [[Page 3448]] any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. The draft guidance relates to four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). Table 1 lists these four rules. Table 1--The Four Foundational FSMA Rules Relevant to the Draft Guidance ---------------------------------------------------------------------------------------------------------------- Title and abbreviations for the Regulatory purpose of this document codification Publication ---------------------------------------------------------------------------------------------------------------- Current Good Manufacturing 21 CFR part 117....... 80 FR 55908, September 17, 2015. Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PC for Human Food regulation). Current Good Manufacturing 21 CFR part 507....... 80 FR 56170, September 17, 2015. Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PC for Animal Food regulation). Standards for the Growing, 21 CFR part 112....... 80 FR 74354, November 27, 2015. Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety regulation). Foreign Supplier Verification 21 CFR part 1, subpart 80 FR 74226, November 27, 2015. Programs for Importers of Food for L. Humans and Animals (FSVP regulation). ---------------------------------------------------------------------------------------------------------------- The FSVP regulation requires, in relevant part, that importers develop, maintain, and follow an FSVP that provides adequate assurances that the foreign supplier of a food is using processes and procedures that provide the SLPHP as those required under part 112 or the preventive controls requirements in part 117 or part 507, respectively, if any is applicable. As incorporated in 21 CFR 1.502(a), this means that importers may import food consistent with the FSVP regulation even if their foreign supplier uses a process or procedure that varies in some way from the processes and procedures required under the applicable requirements in these regulations, provided that the importer follows an FSVP that provides adequate assurance that the processes or procedures that the supplier uses provide the SLPHP as those required under the relevant FDA requirement. Similarly, a provision in the FSVP requirements for dietary supplements, in 21 CFR 1.511(c), also requires that foreign supplier verification activities performed under that section must provide adequate assurances that a supplier is producing the dietary supplement in accordance with processes and procedures that provide the same level of public health protection as those required under 21 CFR part 111 (the dietary supplement current good manufacturing practice regulations). In addition, the Produce Safety regulation includes certain provisions whereby farms may use measures different from those required under part 112, provided all relevant requirements are met, including that those measures must provide the SLPHP as the corresponding FDA-established requirement (Sec. Sec. 112.12, 112.49, and 112.171-182 (Subpart P-- Variances)). The draft guidance describes FDA's current thinking on considerations relevant to SLPHP determinations, specifically in relation to the FSVP, PC for Human Food, PC for Animal Food, and Produce Safety regulations. The draft guidance identifies certain points to consider that a competent authority, a farm, a facility, an importer, or other relevant entity should take into consideration when evaluating whether a measure that is different from that required under part 112 or the preventive controls requirements in part 117 or 507 meets the SLPHP threshold under the FSVP or Produce Safety regulations. In addition, FDA expects to apply these same points in our own evaluations of whether a measure that is different from that required under the applicable provisions of these regulations provides the same level of public health protection as the corresponding requirement. These points are intended to provide a general framework for evaluating the adequacy of a measure to provide the necessary level of public health protection that FDA determined is appropriate by establishing the corresponding requirement. We rely on an overarching principle that an SLPHP determination should be supported by sound scientific evidence that is analyzed by competent individuals, taking into account any unique measure-specific considerations. There are different scenarios under which an SLPHP evaluation may be conducted, and we recognize that an evaluation of a measure's level of public health protection compared to the corresponding FDA requirement can vary widely, including with respect to the scope of evaluation and the entity that conducts the evaluation. Although the points to consider can be flexibly used, as appropriate and applicable, considering the specific circumstances applicable to the measure and the context for its evaluation, we expect using these points will help achieve consistency in the application of the concept of SLPHP across different circumstances and by different entities. As we implement the FSMA rules, FDA will also consider what, if any, training may be necessary for our personnel to better understand and apply these points, and help ensure consistency in our evaluations for SLPHP determinations. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB control number 0910-0751. The collections of information in part 507 have been approved under OMB control number 0910-0789. The collections of information in part 112 have been approved under OMB control number 0910-0816. The collections of information in part 1, subpart L, have been approved under OMB control number 0910-0752. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. [[Page 3449]] Dated: January 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01296 Filed 1-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules 3447
DEPARTMENT OF HEALTH AND the docket unchanged. Because your claimed confidential information
HUMAN SERVICES comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
Food and Drug Administration comment does not include any https://www.regulations.gov. Submit
confidential information that you or a both copies to the Dockets Management
21 CFR Parts 1, 112, 117, and 507 third party may not wish to be posted, Staff. If you do not wish your name and
[Docket No. FDA–2017–D–0397] such as medical information, your or contact information to be made publicly
anyone else’s Social Security number, or available, you can provide this
Considerations for Determining confidential business information, such information on the cover sheet and not
Whether a Measure Provides the Same as a manufacturing process. Please note in the body of your comments and you
Level of Public Health Protection as that if you include your name, contact must identify this information as
the Corresponding Requirement in 21 information, or other information that ‘‘confidential.’’ Any information marked
CFR Part 112 or the Preventive identifies you in the body of your as ‘‘confidential’’ will not be disclosed
Controls Requirements in Part 117 or comments, that information will be except in accordance with 21 CFR 10.20
507; Draft Guidance for Industry; posted on https://www.regulations.gov. and other applicable disclosure law. For
Availability • If you want to submit a comment more information about FDA’s posting
with confidential information that you of comments to public dockets, see 80
AGENCY: Food and Drug Administration, do not wish to be made available to the FR 56469, September 18, 2015, or access
HHS. public, submit the comment as a the information at: https://www.gpo.gov/
ACTION: Notification of availability. written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper 23389.pdf.
SUMMARY: The Food and Drug
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Administration (FDA, we, or Agency) is
announcing the availability of a draft Written/Paper Submissions read background documents or the
guidance for industry entitled electronic and written/paper comments
Submit written/paper submissions as
‘‘Considerations for Determining received, go to https://
follows:
www.regulations.gov and insert the
Whether a Measure Provides the Same • Mail/Hand delivery/Courier (for
Level of Public Health Protection as the docket number, found in brackets in the
written/paper submissions): Dockets
Corresponding Requirement in 21 CFR heading of this document, into the
Management Staff (HFA–305), Food and
112 or the Preventive Controls ‘‘Search’’ box and follow the prompts
Drug Administration, 5630 Fishers
Requirements in Part 117 or 507.’’ The and/or go to the Dockets Management
Lane, Rm. 1061, Rockville, MD 20852.
draft guidance describes FDA’s current • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
thinking on the concept of ‘‘same level submitted to the Dockets Management Rockville, MD 20852.
of public health protection’’ (SLPHP), Staff, FDA will post your comment, as You may submit comments on any
and FDA’s expectations for how an well as any attachments, except for guidance at any time (see 21 CFR
SLPHP evaluation should be conducted information submitted, marked and 10.115(g)(5)).
and an SLPHP determination should be identified, as confidential, if submitted Submit written requests for single
reached. The draft guidance identifies as detailed in ‘‘Instructions.’’ copies of the draft guidance to the
certain points to consider that a Instructions: All submissions received Center for Food Safety and Applied
competent authority, a farm, a facility, must include the Docket No. FDA– Nutrition (HFS–300), Food and Drug
an importer, or other relevant entity 2017–D–0397 for ‘‘Considerations for Administration, 5001 Campus Dr.,
should take into consideration when Determining Whether a Measure College Park, MD 20740. Send one self-
evaluating whether a measure that is Provides the Same Level of Public addressed adhesive label to assist that
different from that required under (part Health Protection as the Corresponding office in processing your requests. See
112) 21 CFR part 112 or the preventive Requirement in 21 CFR 112 or the the SUPPLEMENTARY INFORMATION section
controls requirements in (part 117 or Preventive Controls Requirements in for electronic access to the draft
part 507) 21 CFR part 117 or 507 meets Part 117 or 507.’’ Received comments guidance document.
the SLPHP threshold under the foreign will be placed in the docket and, except FOR FURTHER INFORMATION CONTACT: Ritu
supplier verification program (FSVP) for those submitted as ‘‘Confidential Nalubola, Office of Policy, Food and
regulation (21 CFR part 1, subpart L) or Submissions,’’ publicly viewable at Drug Administration, 10903 New
under part 112. https://www.regulations.gov or at the Hampshire Ave., Silver Spring, MD
DATES: Submit either electronic or Dockets Management Staff between 9 20993, 301–796–3252.
written comments on the draft guidance a.m. and 4 p.m., Monday through SUPPLEMENTARY INFORMATION:
by May 25, 2018 to ensure that the Friday.
• Confidential Submissions—To I. Background
Agency considers your comment on this
draft guidance before it begins work on submit a comment with confidential We are announcing the availability of
the final version of the guidance. information that you do not wish to be a draft guidance for industry entitled
ADDRESSES: You may submit comments made publicly available, submit your ‘‘Considerations for Determining
on any guidance at any time as follows: comments only as a written/paper Whether a Measure Provides the Same
submission. You should submit two Level of Public Health Protection as the
Electronic Submissions copies total. One copy will include the Corresponding Requirement in 21 CFR
sradovich on DSK3GMQ082PROD with PROPOSALS
Submit electronic comments in the information you claim to be confidential 112 or the Preventive Controls
following way: with a heading or cover note that states Requirements in Part 117 or 507.’’ We
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS are issuing the draft guidance consistent
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The with FDA’s good guidance practices
instructions for submitting comments. Agency will review this copy, including regulation (21 CFR 10.115). The draft
Comments submitted electronically, the claimed confidential information, in guidance, when finalized, will represent
including attachments, to https:// its consideration of comments. The the current thinking of FDA on this
www.regulations.gov will be posted to second copy, which will have the topic. It does not establish any rights for
VerDate Sep<11>2014 16:54 Jan 24, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4702 Sfmt 4702 E:\FR\FM\25JAP1.SGM 25JAP1](https://thefederalregister.org/doc/83_FR_3464/page/1.svg)
![Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules 3449
Dated: January 18, 2018. confidential business information, such ‘‘confidential.’’ Any information marked
Leslie Kux, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2018–01296 Filed 1–24–18; 8:45 am] information, or other information that and other applicable disclosure law. For
BILLING CODE 4164–01–P identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment the information at: https://www.gpo.gov/
HUMAN SERVICES with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
21 CFR Part 117 manner detailed (see ‘‘Written/Paper electronic and written/paper comments
[Docket No. FDA–2016–D–2343]
Submissions’’ and ‘‘Instructions’’). received, go to https://
www.regulations.gov and insert the
Written/Paper Submissions
Hazard Analysis and Risk-Based docket number, found in brackets in the
Preventive Controls for Human Food; Submit written/paper submissions as heading of this document, into the
Draft Guidance for Industry; follows: ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management
Availability
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and Rockville, MD 20852.
HHS. Drug Administration, 5630 Fishers You may submit comments on any
ACTION: Notification of availability. Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
• For written/paper comments 10.115(g)(5)).
SUMMARY: The Food and Drug submitted to the Dockets Management Submit written requests for single
Administration (FDA, we, or Agency) is Staff, FDA will post your comment, as copies of the draft guidance to Office of
announcing the availability of another well as any attachments, except for Food Safety, Center for Food Safety and
draft chapter of a multichapter guidance information submitted, marked and Applied Nutrition, Food and Drug
for industry entitled ‘‘Hazard Analysis identified, as confidential, if submitted Administration (HFS–300), 5001
and Risk-Based Preventive Controls for as detailed in ‘‘Instructions.’’ Campus Dr., College Park, MD 20740.
Human Food: Draft Guidance for Instructions: All submissions received Send two self-addressed adhesive labels
Industry.’’ This multichapter draft must include the Docket No. FDA– to assist that office in processing your
guidance is intended to explain our 2016–D–2343 for ‘‘Hazard Analysis and request. See the SUPPLEMENTARY
current thinking on how to comply with Risk-Based Preventive Controls for INFORMATION section for electronic
the requirements for hazard analysis Human Food: Draft Guidance for access to the draft guidance.
and risk-based preventive controls Industry.’’ Received comments will be FOR FURTHER INFORMATION CONTACT:
under our rule entitled ‘‘Current Good placed in the docket and, except for Jenny Scott, Center for Food Safety and
Manufacturing Practice, Hazard those submitted as ‘‘Confidential Applied Nutrition (HFS–300), Food and
Analysis, and Risk-Based Preventive Submissions,’’ publicly viewable at Drug Administration, 5001 Campus Dr.,
Controls for Human Food.’’ The newly https://www.regulations.gov or at the College Park, MD 20740, 240–402–2166.
available draft chapter is entitled Dockets Management Staff between 9 SUPPLEMENTARY INFORMATION:
‘‘Chapter 15—Supply-Chain Program for a.m. and 4 p.m., Monday through
Human Food Products.’’ Friday. I. Background
DATES: Submit either electronic or • Confidential Submissions—To The FDA Food Safety Modernization
written comments by May 25, 2018 to submit a comment with confidential Act (FSMA) (Pub. L. 111–353) enables
ensure that the Agency considers your information that you do not wish to be FDA to better protect public health by
comment on this draft guidance before made publicly available, submit your helping to ensure the safety and security
it begins work on the final version of the comments only as a written/paper of the food supply. It enables FDA to
guidance. submission. You should submit two focus more on preventing food safety
ADDRESSES: You may submit comments copies total. One copy will include the problems rather than relying primarily
on any guidance at any time as follows: information you claim to be confidential on reacting to problems after they occur.
with a heading or cover note that states FSMA recognizes the important role
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS industry plays in ensuring the safety of
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The the food supply, including the adoption
following way: Agency will review this copy, including of modern systems of preventive
• Federal eRulemaking Portal: the claimed confidential information, in controls in food production.
https://www.regulations.gov. Follow the its consideration of comments. The Section 103 of FSMA amended
instructions for submitting comments. second copy, which will have the section 418 of the Federal Food, Drug,
Comments submitted electronically, claimed confidential information and Cosmetic Act (FD&C Act) (21 U.S.C.
including attachments, to https:// redacted/blacked out, will be available 350g) by adding requirements for hazard
www.regulations.gov will be posted to for public viewing and posted on analysis and risk-based preventive
sradovich on DSK3GMQ082PROD with PROPOSALS
the docket unchanged. Because your https://www.regulations.gov. Submit controls for establishments that are
comment will be made public, you are both copies to the Dockets Management required to register as food facilities
solely responsible for ensuring that your Staff. If you do not wish your name and under our regulations, in 21 CFR part 1,
comment does not include any contact information to be made publicly subpart H, in accordance with section
confidential information that you or a available, you can provide this 415 of the FD&C Act (21 U.S.C. 350d).
third party may not wish to be posted, information on the cover sheet and not We have established regulations to
such as medical information, your or in the body of your comments and you implement these requirements within
anyone else’s Social Security number, or must identify this information as part 117 (21 CFR part 117).
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Document Created: 2018-01-25 08:50:36
Document Modified: 2018-01-25 08:50:36
| 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 | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Ritu Nalubola, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3252. | |
| FR Citation | 83 FR 3447 | |
| CFR Citation | 21
CFR
1 21 CFR 112 21 CFR 117 21 CFR 507 |
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