83_FR_24229 83 FR 24128 - Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Guidance for Industry; Availability

83 FR 24128 - Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 101 (May 24, 2018)

Page Range24128-24129
FR Document2018-11117

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose of this guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This guidance finalizes the draft guidance of the same name issued on February 16, 2016.

Federal Register, Volume 83 Issue 101 (Thursday, May 24, 2018) 
[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24128-24129]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0412]


Anthrax: Developing Drugs for Prophylaxis of Inhalational 
Anthrax; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Anthrax: 
Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose 
of this guidance is to assist sponsors in the development of new drugs 
for the prophylaxis of inhalational anthrax. This guidance finalizes 
the draft guidance of the same name issued on February 16, 2016.

DATES: The announcement of the guidance is published in the Federal 
Register on May 24, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 24129]]

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-2016-D-0412 for ``Anthrax: Developing Drugs for Prophylaxis of 
Inhalational Anthrax.'' 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 this 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. Send one self-
addressed 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: Joseph G. Toerner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational 
Anthrax.'' The purpose of this guidance is to assist sponsors in the 
development of new drugs to be administered to people who have or may 
have inhaled Bacillus anthracis spores, but who have not yet manifested 
clinical evidence of disease, to prevent the development of 
inhalational anthrax. This guidance clarifies that drugs for the 
prophylaxis of inhalational anthrax are to be considered for approval 
under the animal rule regulations because human efficacy trials are not 
ethical or feasible (21 CFR part 314, subpart I, for drugs, and 21 CFR 
part 601, subpart H, for biological products).
    This guidance finalizes the draft guidance of the same name issued 
on February 16, 2016 (81 FR 7813). Changes made to the guidance took 
into consideration written and verbal comments received. In addition to 
changes primarily for clarification, the major changes are as follows: 
Clarity in defining specific populations that would receive a drug for 
prophylaxis of inhalational anthrax, for example, first responders who 
anticipate exposure to Bacillus anthracis spores and initiate drug 
therapy immediately before exposure. In addition, the guidance was 
updated to provide consistency with the guidance for industry entitled 
``Product Development Under the Animal Rule'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm399217.pdf).
    Issuance of this guidance fulfills a portion of the requirements of 
Title VIII, section 804, of the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-144), which requires FDA to review and, as 
appropriate, revise not fewer than three guidance documents per year 
for the conduct of clinical trials with respect to antibacterial and 
antifungal drugs.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on prophylaxis of inhalational anthrax. 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. This guidance 
is not subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that 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 parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: May 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11117 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P

24128 Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual Average burden 21 CFR section/activity responses per Total hours respondents responses per response respondent 203.11—Reimportation ................................................... 1 1 1 0.5 (30 minutes) 1 203.30(a)(1) and (b)—Drug sample requests ................ 61,961 12 743,532 0.06 (4 minutes) 44,612 203.30(a)(3), (a)(4), and (c)—Drug sample receipts ...... 61,961 12 743,532 0.06 (4 minutes) 44,612 203.31(a)(1) and (b)—Drug sample requests ................ 232,355 135 31,367,925 0.04 (2.5 minutes) 1,254,717 203.31(a)(3), (a)(4), and (c)—Drug sample receipts ...... 232,355 135 31,367,925 0.03 (2 minutes) 941,038 203.37(a)—Falsification of records ................................. 50 4 200 0.25 (15 minutes) 50 203.37(b)—Loss or theft of samples .............................. 50 40 2,000 0.25 (15 minutes) 500 203.37(c)—Convictions ................................................... 1 1 1 1 .......................... 1 203.37(d)—Contact person ............................................ 50 1 50 0.08 (5 minutes) 4 203.39(g)—Reconciliation report .................................... 1 1 1 1 .......................... 1 Total ......................................................................... ........................ ........................ ........................ ............................. 2,285,536 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Number of Total annual Average burden 21 CFR Section/Activity records per Total hours recordkeepers records per recordkeeping recordkeeper 203.23(a) and (b)—Returned drugs ............................... 31,676 5 158,380 0.25 (15 minutes) 39,595 203.23(c)—Returned drugs documentation ................... 31,676 5 158,380 0.08 (5 minutes) 12,670 203.30(a)(2) and 203.31(a)(2)—Practitioner verification 2,208 100 220,800 0.5 (30 minutes) 110,400 203.31(d)(1) and (2)—Inventory record and reconcili- 2,208 1 2,208 40 ........................ 88,320 ation report. 203.31(d)(4)—Investigation of discrepancies and losses 442 1 442 24 ........................ 10,608 203.31(e)—Representatives lists .................................... 2,208 1 2,208 1 .......................... 2,208 203.34—Administrative systems .................................... 90 1 90 40 ........................ 3,600 203.37(a)—Falsification of drug sample records ........... 50 4 200 6 .......................... 1,200 203.37(b)—Loss or theft of drug samples ...................... 50 40 2,000 6 .......................... 12,000 203.39(d)—Destroyed or returned drug samples ........... 65 1 65 1 .......................... 65 203.39(e)—Donated drug samples ................................ 3,221 1 3,221 0.5 (30 minutes) 1,611 203.39(f)—Distribution of donated drug samples ........... 3,221 1 3,221 8 .......................... 25,768 203.39(g)—Drug samples donated to charitable institu- 3,221 1 3,221 8 .......................... 25,768 tions. 203.50(a)—Drug origin statement .................................. 125 100 12,500 0.17 (10 minutes) 2,125 203.50(b)—Drug origin statement retention ................... 125 100 12,500 0.5 (30 minutes) 6,250 203.50(d)—Authorized distributors of record ................. 691 1 691 2 .......................... 1,382 Total ......................................................................... ........................ ........................ ........................ ............................. 343,570 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of Agency data, we ACTION: Notice of availability. Electronic Submissions retain the currently approved burden estimate for the information collection, SUMMARY: The Food and Drug Submit electronic comments in the as reflected in tables 1 and 2 above. Administration (FDA or Agency) is following way: Dated: May 18, 2018. announcing the availability of a • Federal eRulemaking Portal: Leslie Kux, guidance for industry entitled ‘‘Anthrax: https://www.regulations.gov. Follow the Associate Commissioner for Policy. Developing Drugs for Prophylaxis of instructions for submitting comments. Inhalational Anthrax.’’ The purpose of Comments submitted electronically, [FR Doc. 2018–11113 Filed 5–23–18; 8:45 am] this guidance is to assist sponsors in the including attachments, to https:// BILLING CODE 4164–01–P development of new drugs for the www.regulations.gov will be posted to prophylaxis of inhalational anthrax. the docket unchanged. Because your comment will be made public, you are DEPARTMENT OF HEALTH AND This guidance finalizes the draft HUMAN SERVICES solely responsible for ensuring that your guidance of the same name issued on comment does not include any February 16, 2016. Food and Drug Administration confidential information that you or a third party may not wish to be posted, sradovich on DSK3GMQ082PROD with NOTICES DATES: The announcement of the [Docket No. FDA–2016–D–0412] such as medical information, your or guidance is published in the Federal Register on May 24, 2018. anyone else’s Social Security number, or Anthrax: Developing Drugs for confidential business information, such Prophylaxis of Inhalational Anthrax; ADDRESSES: You may submit either as a manufacturing process. Please note Guidance for Industry; Availability electronic or written comments on that if you include your name, contact AGENCY: Food and Drug Administration, Agency guidances at any time as information, or other information that HHS. follows: identifies you in the body of your VerDate Sep<11>2014 18:10 May 23, 2018 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\24MYN1.SGM 24MYN1

Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices 24129 comments, that information will be FR 56469, September 18, 2015, or access defining specific populations that posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ would receive a drug for prophylaxis of • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- inhalational anthrax, for example, first with confidential information that you 23389.pdf. responders who anticipate exposure to do not wish to be made available to the Docket: For access to the docket to Bacillus anthracis spores and initiate public, submit the comment as a read background documents or the drug therapy immediately before written/paper submission and in the electronic and written/paper comments exposure. In addition, the guidance was manner detailed (see ‘‘Written/Paper received, go to https:// updated to provide consistency with the Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the guidance for industry entitled ‘‘Product Written/Paper Submissions docket number, found in brackets in the Development Under the Animal Rule’’ heading of this document, into the (available at https://www.fda.gov/ucm/ Submit written/paper submissions as ‘‘Search’’ box and follow the prompts follows: groups/fdagov-public/@fdagov-drugs- and/or go to the Dockets Management • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, gen/documents/document/ written/paper submissions): Dockets ucm399217.pdf). Rockville, MD 20852. Management Staff (HFA–305), Food and You may submit comments on any Issuance of this guidance fulfills a Drug Administration, 5630 Fishers guidance at any time (see 21 CFR portion of the requirements of Title VIII, Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). section 804, of the Food and Drug • For written/paper comments Submit written requests for single Administration Safety and Innovation submitted to the Dockets Management copies of this guidance to the Division Act (Pub. L. 112–144), which requires Staff, FDA will post your comment, as of Drug Information, Center for Drug FDA to review and, as appropriate, well as any attachments, except for Evaluation and Research, Food and revise not fewer than three guidance information submitted, marked and Drug Administration, 10001 New documents per year for the conduct of identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, clinical trials with respect to Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– antibacterial and antifungal drugs. must include the Docket No. FDA– 0002. Send one self-addressed adhesive label to assist that office in processing This guidance is being issued 2016–D–0412 for ‘‘Anthrax: Developing consistent with FDA’s good guidance Drugs for Prophylaxis of Inhalational your requests. See the SUPPLEMENTARY INFORMATION section for electronic practices regulation (21 CFR 10.115). Anthrax.’’ Received comments will be The guidance represents the current placed in the docket and, except for access to the guidance document. FOR FURTHER INFORMATION CONTACT: thinking of FDA on prophylaxis of those submitted as ‘‘Confidential inhalational anthrax. It does not Submissions,’’ publicly viewable at Joseph G. Toerner, Center for Drug Evaluation and Research, Food and establish any rights for any person and https://www.regulations.gov or at the Drug Administration, 10903 New is not binding on FDA or the public. Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 6244, You can use an alternative approach if Friday. Silver Spring, MD 20993–0002, 301– it satisfies the requirements of the • Confidential Submissions—To 796–1400. applicable statutes and regulations. This submit a comment with confidential SUPPLEMENTARY INFORMATION: guidance is not subject to Executive information that you do not wish to be Order 12866. made publicly available, submit your I. Background II. The Paperwork Reduction Act of comments only as a written/paper FDA is announcing the availability of 1995 submission. You should submit two a guidance for industry entitled copies total. One copy will include the ‘‘Anthrax: Developing Drugs for This guidance refers to previously information you claim to be confidential Prophylaxis of Inhalational Anthrax.’’ approved collections of information that with a heading or cover note that states The purpose of this guidance is to assist are subject to review by the Office of ‘‘THIS DOCUMENT CONTAINS sponsors in the development of new Management and Budget (OMB) under CONFIDENTIAL INFORMATION.’’ The drugs to be administered to people who the Paperwork Reduction Act of 1995 Agency will review this copy, including have or may have inhaled Bacillus (44 U.S.C. 3501–3520). The collections the claimed confidential information, in anthracis spores, but who have not yet of information in 21 CFR parts 312 and its consideration of comments. The manifested clinical evidence of disease, 314 have been approved under OMB second copy, which will have the to prevent the development of control numbers 0910–0014 and 0910– claimed confidential information inhalational anthrax. This guidance 0001, respectively. redacted/blacked out, will be available clarifies that drugs for the prophylaxis for public viewing and posted on of inhalational anthrax are to be III. Electronic Access https://www.regulations.gov. Submit considered for approval under the both copies to the Dockets Management animal rule regulations because human Persons with access to the internet Staff. If you do not wish your name and efficacy trials are not ethical or feasible may obtain the guidance at either contact information to be made publicly (21 CFR part 314, subpart I, for drugs, https://www.fda.gov/Drugs/Guidance available, you can provide this and 21 CFR part 601, subpart H, for ComplianceRegulatoryInformation/ information on the cover sheet and not biological products). Guidances/default.htm or https:// in the body of your comments and you This guidance finalizes the draft www.regulations.gov. sradovich on DSK3GMQ082PROD with NOTICES must identify this information as guidance of the same name issued on Dated: May 21, 2018. ‘‘confidential.’’ Any information marked February 16, 2016 (81 FR 7813). Leslie Kux, as ‘‘confidential’’ will not be disclosed Changes made to the guidance took into except in accordance with 21 CFR 10.20 consideration written and verbal Associate Commissioner for Policy. and other applicable disclosure law. For comments received. In addition to [FR Doc. 2018–11117 Filed 5–23–18; 8:45 am] more information about FDA’s posting changes primarily for clarification, the BILLING CODE 4164–01–P of comments to public dockets, see 80 major changes are as follows: Clarity in VerDate Sep<11>2014 18:10 May 23, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 9990 E:\FR\FM\24MYN1.SGM 24MYN1


Document Created: 2018-05-24 00:05:27
Document Modified: 2018-05-24 00:05:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on May 24, 2018.
ContactJoseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301- 796-1400.
FR Citation83 FR 24128 
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