Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability; Correction, 78336-78337 [2020-26691]

Download as PDF 78336 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices We estimate the burden of the collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Activity using form FDA 3757; 21 CFR Average burden per response (in hours) Total annual responses Total hours Initial Registration for Vending Machine Labeling; 101.8(d) ................. Registration Renewal for Vending Machine Labeling; 101.8(d) ........... Initial Registration for Menu Labeling; 101.11(d) .................................. Registration Renewal for Menu Labeling; 101.11(d) ............................ 13 19 3,559 5,340 1 1 1 1 13 19 3,559 5,340 2 ..................................... 0.5 (30 minutes) ............ 2 ..................................... 0.5 (30 minutes) ............ 26 9.5 7,118 2,670 Total ............................................................................................... ........................ ........................ ........................ ........................................ 9,823.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1 Number of recordkeepers Activity; 21 CFR Number of records per recordkeeper Average burden per record (in hours) Total annual records Total hours Initial Burden (Annualized over 3 years) Initial Nutrition Analysis; 101.8(c)(2)(i)(A) ............................................. 69,017 1 69,017 0.25 (15 minutes) .......... 17,254 Annual Burden Recurring Nutrition Analysis; 101.8(c)(2)(i)(A) ...................................... 30,059 1 30,059 0.25 (15 minutes) .......... 7,515 Total ............................................................................................... ........................ ........................ ........................ ........................................ 24,769 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents Activity; 21 CFR Number of disclosures per respondent Average burden per disclosure (in hours) Total annual disclosures Total hours Calorie Analysis; 101.8(c)(2)(i) ....................................................... Calorie Declaration Signage; 101.8(c)(2)(ii) ................................... Vending Operator Contact Information; 101.8(e)(1) ....................... 282 3,279 3,279 11 2,122 125 3,102 6,958,038 409,875 1 ..................................... 0.21 (12.5 minutes) ....... 0.025 (1.5 minutes) ....... 3,102 1,461,188 10,247 Total ......................................................................................... ........................ .............................. ........................ ........................................ 1,474,537 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 30, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [Docket No. FDA–2017–D–5739] [FR Doc. 2020–26695 Filed 12–3–20; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability; Correction AGENCY: Food and Drug Administration, Notice of availability. The Food and Drug Administration (FDA or Agency) is correcting a notice entitled ‘‘Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability’’ that appeared in the Federal Register of November 25, SUMMARY: VerDate Sep<11>2014 18:18 Dec 03, 2020 Jkt 253001 PO 00000 In the Federal Register of November 25, 2020 (85 FR 75336), in FR Doc. 2020–26050, the following correction is made: On page 75337, in the third column, under the heading, ‘‘II. Paperwork Reduction Act of 1995’’, the paragraph is corrected to read: ‘‘While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget SUPPLEMENTARY INFORMATION: HHS. ACTION: 2020. The document announced the availability for a guidance for industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993–0002, 240– 402–7930, elizabeth.giaquinto@ fda.hhs.gov. Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information for meetings related to generic drug development have been approved under OMB control number 0910–0797.’’ Dated: November 30, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–26691 Filed 12–3–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–4739] Requesting FDA Feedback on Combination Products; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ‘‘Requesting FDA Feedback on Combination Products.’’ The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate. SUMMARY: The announcement of the guidance is published in the Federal Register on December 4, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 18:18 Dec 03, 2020 Jkt 253001 • 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– 2019–D–4739 for ‘‘Requesting FDA Feedback on Combination Products.’’ 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, 240–402–7500. • 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 78337 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. 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 guidance to the to the Office of Combination Products, Food and Drug Administration, Bldg. 32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5125, 301–796– 5616, melissa.burns@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Requesting FDA Feedback on Combination Products.’’ The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from the Agency on scientific and regulatory questions. These interactions can occur through application-based mechanisms, such as the pre-submission process used in E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78336-78337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5739]


Formal Meetings Between the Food and Drug Administration and 
Abbreviated New Drug Application Applicants of Complex Products Under 
Generic Drug User Fee Amendments; Guidance for Industry; Availability; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting 
a notice entitled ``Formal Meetings Between the Food and Drug 
Administration and Abbreviated New Drug Application Applicants of 
Complex Products Under Generic Drug User Fee Amendments; Guidance for 
Industry; Availability'' that appeared in the Federal Register of 
November 25, 2020. The document announced the availability for a 
guidance for industry. The document was published with incorrect 
information in the Paperwork Reduction Act of 1995 section. This 
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 
240-402-7930, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of November 25, 2020 
(85 FR 75336), in FR Doc. 2020-26050, the following correction is made:
    On page 75337, in the third column, under the heading, ``II. 
Paperwork Reduction Act of 1995'', the paragraph is corrected to read:
    ``While this guidance contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget

[[Page 78337]]

(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved 
collections of information are subject to review by OMB under the PRA. 
The collections of information for meetings related to generic drug 
development have been approved under OMB control number 0910-0797.''

    Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26691 Filed 12-3-20; 8:45 am]
BILLING CODE 4164-01-P
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