Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry; Availability, 14202-14203 [2020-04994]

Download as PDF 14202 Federal Register / Vol. 85, No. 48 / Wednesday, March 11, 2020 / Notices random audits. The random audits are conducted on the carriers that use numbering resources in order to verify the accuracy of numbering data reported on FCC Form 502, and to monitor compliance with FCC rules, orders and applicable industry guidelines. Failure of the audited carriers to respond to the audits can result in penalties. Based on the final audit report, evidence of potential violations may result in enforcement action. Federal Communications Commission. Cecilia Sigmund, Federal Register Liaison Officer, Office of the Secretary. Filing Party: Wayne Rohde; Cozen O’Connor. Synopsis: This amendment revises Article 5.6(c) of the Agreement to exclude tug services from the services for which the parties are authorized to negotiate jointly. Proposed Effective Date: 3/5/2020. Location: https://www2.fmc.gov/ FMC.Agreements.Web/Public/ AgreementHistory/2021. Dated: March 6, 2020. Rachel Dickon, Secretary. [FR Doc. 2020–05002 Filed 3–10–20; 8:45 am] BILLING CODE 6731–AA–P [FR Doc. 2020–04967 Filed 3–10–20; 8:45 am] BILLING CODE 6712–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES FEDERAL MARITIME COMMISSION Food and Drug Administration lotter on DSKBCFDHB2PROD with NOTICES Notice of Agreements Filed The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreements to the Secretary by email at Secretary@ fmc.gov, or by mail, Federal Maritime Commission, Washington, DC 20573. Comments will be most helpful to the Commission if received within 12 days of the date this notice appears in the Federal Register. Copies of agreements are available through the Commission’s website (www.fmc.gov) or by contacting the Office of Agreements at (202)–523– 5793 or tradeanalysis@fmc.gov. Agreement No.: 201334. Agreement Name: COSCO/ONE/ OOCL/YM EMED–USEC Vessel Sharing Agreement. Parties: COSCO SHIPPING Lines Co., Ltd.; Ocean Network Express Pte. Ltd.; Orient Overseas Container Line Limited; and Yang Ming Marine Transport Corp., Yang Ming (UK) Ltd., and Yang Ming (Singapore) Pte. Ltd. (acting as a single party). Filing Party: Joshua Stein; Cozen O’Connor. Synopsis: The Agreement authorizes the parties to cooperate on the provision of a service operating between the U.S. East Coast and ports in the Mediterranean. Proposed Effective Date: 3/4/2020. Location: https://www2.fmc.gov/ FMC.Agreements.Web/Public/ AgreementHistory/27479. Agreement No.: 012056–002. Agreement Name: WWOcean/EUKOR Joint Operating Agreement. Parties: Wallenius Wilhelmsen Ocean AS and EUKOR Car Carriers, Inc. VerDate Sep<11>2014 16:37 Mar 10, 2020 Jkt 250001 [Docket No. FDA–2020–D–0420] Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Alternate Electronic Format.’’ Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA the authority to implement the statutory electronic submission requirements in guidance. In response, FDA implemented binding guidance requiring that new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) be submitted to the Agency in electronic common technical document (eCTD) format. Recognizing that some submissions are exempt from this requirement and that waivers of the requirement may be granted on a caseby-case basis, the Agency is issuing this draft guidance to describe the alternate electronic format sponsors or applicants should use for submissions covered under such exemptions and waivers. DATES: Submit either electronic or written comments on the draft guidance by May 11, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. SUMMARY: PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 You may submit comments on any guidance at any time as follows: ADDRESSES: 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– 2020–D–0420 for ‘‘Providing Regulatory Submissions in Alternate Electronic Format.’’ 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 E:\FR\FM\11MRN1.SGM 11MRN1 lotter on DSKBCFDHB2PROD with NOTICES Federal Register / Vol. 85, No. 48 / Wednesday, March 11, 2020 / Notices 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.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. 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 Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. 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: Dat Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3334, Silver Spring, MD 20993–0002, 240–402–8926; or VerDate Sep<11>2014 16:37 Mar 10, 2020 Jkt 250001 Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Alternate Electronic Format.’’ This draft guidance provides recommendations on an alternate electronic format for submissions that are covered under an exemption from or granted a waiver of the requirements of section 745A(a) of the FD&C Act (21 U.S.C. 379k–1). These recommendations pertain to the electronic format of content in NDAs, ANDAs, DMFs, certain BLAs, and certain INDs submitted to the Center for Drug Evaluation and Research or to the Center for Biologics Evaluation and Research. This draft guidance includes information on: (1) How to submit in alternate electronic format (without xml backbone), (2) submission of FDA forms, (3) pre-submission considerations, (4) submission structure, (5) file formats and versions, (6) datasets and study information, (7) transmitting electronic submissions, and (8) receipt dates. This draft guidance is being issued 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 ‘‘Providing Regulatory Submissions in Alternate Electronic Format.’’ 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. II. 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 21 CFR part 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 14203 III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// www.regulations.gov. Dated: March 6, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–04994 Filed 3–10–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1156] Q3D(R1) Elemental Impurities; International Council for Harmonisation; Guidance for Industry; 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 revised final guidance for industry entitled ‘‘Q3D(R1) Elemental Impurities.’’ The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance finalizes the draft guidance ‘‘Q3D(R1) Elemental Impurities’’ published on July 13, 2018. This guidance revises the existing guidance for industry ‘‘Q3D Elemental Impurities’’ and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms (mg)/ day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of exposure. This revised guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure. SUMMARY: The announcement of the guidance is published in the Federal Register on March 11, 2020. DATES: You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: E:\FR\FM\11MRN1.SGM 11MRN1

Agencies

[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14202-14203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0420]


Providing Regulatory Submissions in Alternate Electronic Format; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Providing Regulatory Submissions in Alternate Electronic Format.'' 
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress 
granted FDA the authority to implement the statutory electronic 
submission requirements in guidance. In response, FDA implemented 
binding guidance requiring that new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), certain drug master files 
(DMFs), certain biologics license applications (BLAs), and certain 
investigational new drug applications (INDs) be submitted to the Agency 
in electronic common technical document (eCTD) format. Recognizing that 
some submissions are exempt from this requirement and that waivers of 
the requirement may be granted on a case-by-case basis, the Agency is 
issuing this draft guidance to describe the alternate electronic format 
sponsors or applicants should use for submissions covered under such 
exemptions and waivers.

DATES: Submit either electronic or written comments on the draft 
guidance by May 11, 2020 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-2020-D-0420 for ``Providing Regulatory Submissions in Alternate 
Electronic Format.'' 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

[[Page 14203]]

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.govinfo.gov/content/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 Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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: Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002, 240-402-8926; or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Alternate Electronic 
Format.'' This draft guidance provides recommendations on an alternate 
electronic format for submissions that are covered under an exemption 
from or granted a waiver of the requirements of section 745A(a) of the 
FD&C Act (21 U.S.C. 379k-1). These recommendations pertain to the 
electronic format of content in NDAs, ANDAs, DMFs, certain BLAs, and 
certain INDs submitted to the Center for Drug Evaluation and Research 
or to the Center for Biologics Evaluation and Research.
    This draft guidance includes information on: (1) How to submit in 
alternate electronic format (without xml backbone), (2) submission of 
FDA forms, (3) pre-submission considerations, (4) submission structure, 
(5) file formats and versions, (6) datasets and study information, (7) 
transmitting electronic submissions, and (8) receipt dates.
    This draft guidance is being issued 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 ``Providing 
Regulatory Submissions in Alternate Electronic Format.'' 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.

II. 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 21 CFR part 312 have been approved under 
OMB control number 0910-0014; the collections of information in 21 CFR 
part 314 have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: March 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04994 Filed 3-10-20; 8:45 am]
 BILLING CODE 4164-01-P
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