Document ID: FDA-2018-N-1097-0001
Agency: fda
Document Type: Rule
Title: Good Guidance Practices; Technical Amendment
Posted Date: 2018-03-29T04:00Z

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Rules and Regulations]
[Pages 13415-13416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-2018-N-1097]

Good Guidance Practices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
its good guidance practices regulation to inform the public on how to 
electronically submit a draft of a proposed guidance to the Agency. 
This technical amendment is nonsubstantive.

DATES: This rule is effective March 29, 2018.

FOR FURTHER INFORMATION CONTACT: Megan Velez, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4254, 
Silver Spring, MD 20993-0002, 301-796-9301.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 10.115(f)(3), good 
guidance regulations, by adding language on how the public can 
electronically submit drafts of proposed guidance documents to 
participate in the development and issuance of guidance documents. The 
amendment provides an option for submitting the draft of a proposed 
guidance to the Agency electronically through https://www.regulations.gov at Docket No. FDA-2013-S-0610.
    Publication of this document constitutes final action on the change 
under the Administrative Procedure Act (5 U.S.C. 553). This technical 
amendment is nonsubstantive. FDA therefore, for good cause, has 
determined that notice and public comment are unnecessary under 5 
U.S.C. 553(b)(3)(B). Further, this rule places no burden on affected 
parties for which such parties would need a reasonable time to prepare 
for the effective date of the rule. Accordingly, FDA, for good cause, 
has determined

[[Page 13416]]

this technical amendment to be exempt under 5 U.S.C. 553(d)(3) and that 
the rule can become effective upon publication.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
10 is amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

0
2. In Sec.  10.115, add two sentences to the end of paragraph (f)(3) to 
read as follows:

Sec.  10.115   Good guidance practices.

* * * * *
    (f) * * *
    (3) * * * If you wish to submit the draft of a proposed guidance 
document electronically, submit it through https://www.regulations.gov 
at Docket No. FDA-2013-S-0610. It is only necessary to submit one copy.
* * * * *

    Dated: March 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06252 Filed 3-28-18; 8:45 am]
 BILLING CODE 4164-01-P