Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 6005-6007 [2019-03129]

Download as PDF 6005 Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices had the opportunity to review all of the material relied on for dispute resolution. The information the Agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute; (2) brief statements describing the history of the matter; and (3) the documents previously submitted to FDA under an OMB approved collection of information. Based on FDA’s experience with dispute resolution, the Agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the Agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance document will be minimal. Provided in this document is an estimate of the annual reporting burden for requests for dispute resolution. with the guidance document, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the Agency. Based on experience, FDA estimates that approximately 8 hours, on average, would be needed per response. Therefore, FDA estimates that 8 hours will be spent per year by respondents requesting formal dispute resolution in accordance with the guidance document. In the Federal Register of August 20, 2018 (83 FR 42127), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately 12 sponsors and applicants (respondents) will submit requests for formal dispute resolution to CDER annually and approximately 1 respondent will submit requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 17 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Requests for formal dispute resolution Number of respondents Number of responses per respondent Average burden per response Total hours CDER ................................................................................... CBER ................................................................................... 12 1 1.42 1 17 1 8 8 136 8 Total .............................................................................. ........................ ........................ ........................ ........................ 144 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden for this information collection has changed since the last OMB approval. Our burden estimate reflects a decrease in burden by 14 records and 112 hours. This adjustment corresponds to a decrease in the number of requests received over the last few years. Dated: February 19, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–03193 Filed 2–22–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance. Submit either electronic or written comments on the draft guidance by April 26, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. DATES: amozie on DSK3GDR082PROD with NOTICES1 Total annual responses Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is SUMMARY: VerDate Sep<11>2014 16:22 Feb 22, 2019 Jkt 247001 You may submit comments on any guidance at any time as follows: ADDRESSES: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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 E:\FR\FM\25FEN1.SGM 25FEN1 6006 Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices 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– 2007–D–0369 for ‘‘Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.’’ 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 guidances 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 draft guidance documents. FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993–0002, 240– 402–1146. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s website at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA’s website and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on November 29, 2018 (83 FR 61388). This notice announces draft productspecific guidances, either new or revised, that are posted on FDA’s website. II. Drug Products For Which New Draft Product-Specific Guidances Are Available FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients: amozie on DSK3GDR082PROD with NOTICES1 TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS Acalabrutinib. Acetaminophen; Caffeine; Dihydrocodeine bitartrate. Angiotensin II acetate. Bexarotene. Bosentan. Bromocriptine mesylate. Chlorothiazide. Daptomycin. Dexamethasone. Dihydroergotamine mesylate. Diltiazem hydrochloride. Doxycycline calcium. Doxylamine succinate; Pyridoxine hydrochloride. Fish oil; Medium chain triglycerides; Olive oil; Soybean oil. Isocarboxazid. Ivacaftor; Tezacaftor. Letrozole; Ribociclib succinate. Loratadine; Pseudoephedrine sulfate. Methsuximide. VerDate Sep<11>2014 16:22 Feb 22, 2019 Jkt 247001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices 6007 TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued Ozenoxacin. Paroxetine mesylate. Succimer. III. Drug Products For Which Revised Draft Product-Specific Guidances Are Available for industry for drug products containing the following active ingredients: FDA is announcing the availability of revised draft product-specific guidances TABLE 2—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS amozie on DSK3GDR082PROD with NOTICES1 Acetaminophen; Butalbital. Aripiprazole. Azelastine HCl; Fluticasone propionate. Betamethasone Dipropionate; Calcipotriene Hydrate (multiple Reference Listed Drugs). Betamethasone Dipropionate; Clotrimazole (multiple Reference Listed Drugs). Butenafine HCl (multiple Reference Listed Drugs). Butoconazole nitrate (multiple Reference Listed Drugs). Calcipotriene (multiple Reference Listed Drugs). Ceritinib. Ciclopirox (multiple Reference Listed Drugs). Clotrimazole (multiple Reference Listed Drugs). Crisaborole. Dexamethasone; Tobramycin (multiple Reference Listed Drugs). Diclofenac sodium. Econazole nitrate. Fluorouracil (multiple Reference Listed Drugs). Fluticasone propionate. Haloperidol. Imiquimod (multiple Reference Listed Drugs). Ingenol mebutate (multiple Reference Listed Drugs). Ketoconazole. Lumacaftor; Ivacaftor. Miconazole. Mometasone furoate monohydrate (multiple Reference Listed Drugs). Oxiconazole Nitrate (multiple Reference Listed Drugs). Tazarotene (multiple Reference Listed Drugs). Terbinafine hydrochloride. Treprostinil diethanolamine (multiple Reference Listed Drugs). Tretinoin. Triamcinolone acetonide. For a complete history of previously published Federal Register documents related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are 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. https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: February 19, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [Docket No. FDA–2014–N–1130] [FR Doc. 2019–03129 Filed 2–22–19; 8:45 am] BILLING CODE 4164–01–P Jkt 247001 PO 00000 Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Implanted BrainComputer Interface Devices for Patients with Paralysis or Amputation— Nonclinical Testing and Clinical SUMMARY: Persons with access to the internet may obtain the draft guidances at either 16:22 Feb 22, 2019 Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation—Nonclinical Testing and Clinical Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: IV. Electronic Access VerDate Sep<11>2014 Food and Drug Administration Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Pages 6005-6007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03129]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Product-Specific Guidances; Draft and Revised Draft Guidances for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of additional draft and revised draft product-specific 
guidances. The guidances provide product-specific recommendations on, 
among other things, the design of bioequivalence (BE) studies to 
support abbreviated new drug applications (ANDAs). In the Federal 
Register of June 11, 2010, FDA announced the availability of a guidance 
for industry entitled ``Bioequivalence Recommendations for Specific 
Products'' that explained the process that would be used to make 
product-specific guidances available to the public on FDA's website. 
The guidances identified in this notice were developed using the 
process described in that guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by April 26, 2019 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

[[Page 6006]]

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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised 
Draft Guidances for Industry.'' 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.gpo.gov/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 guidances 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 draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 240-402-1146.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products'' that explained 
the process that would be used to make product-specific guidances 
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means 
to develop and disseminate product-specific guidances and provide a 
meaningful opportunity for the public to consider and comment on those 
guidances. Under that process, draft guidances are posted on FDA's 
website and announced periodically in the Federal Register. The public 
is encouraged to submit comments on those recommendations within 60 
days of their announcement in the Federal Register. FDA considers any 
comments received and either publishes final guidances or publishes 
revised draft guidances for comment. Guidances were last announced in 
the Federal Register on November 29, 2018 (83 FR 61388). This notice 
announces draft product-specific guidances, either new or revised, that 
are posted on FDA's website.

II. Drug Products For Which New Draft Product-Specific Guidances Are 
Available

    FDA is announcing the availability of new draft product-specific 
guidances for industry for drug products containing the following 
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
 
---------------------------------------------------------------------------
Acalabrutinib.
Acetaminophen; Caffeine; Dihydrocodeine bitartrate.
Angiotensin II acetate.
Bexarotene.
Bosentan.
Bromocriptine mesylate.
Chlorothiazide.
Daptomycin.
Dexamethasone.
Dihydroergotamine mesylate.
Diltiazem hydrochloride.
Doxycycline calcium.
Doxylamine succinate; Pyridoxine hydrochloride.
Fish oil; Medium chain triglycerides; Olive oil; Soybean oil.
Isocarboxazid.
Ivacaftor; Tezacaftor.
Letrozole; Ribociclib succinate.
Loratadine; Pseudoephedrine sulfate.
Methsuximide.

[[Page 6007]]

 
Ozenoxacin.
Paroxetine mesylate.
Succimer.
------------------------------------------------------------------------

III. Drug Products For Which Revised Draft Product-Specific Guidances 
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the 
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
 
---------------------------------------------------------------------------
Acetaminophen; Butalbital.
Aripiprazole.
Azelastine HCl; Fluticasone propionate.
Betamethasone Dipropionate; Calcipotriene Hydrate (multiple Reference
 Listed Drugs).
Betamethasone Dipropionate; Clotrimazole (multiple Reference Listed
 Drugs).
Butenafine HCl (multiple Reference Listed Drugs).
Butoconazole nitrate (multiple Reference Listed Drugs).
Calcipotriene (multiple Reference Listed Drugs).
Ceritinib.
Ciclopirox (multiple Reference Listed Drugs).
Clotrimazole (multiple Reference Listed Drugs).
Crisaborole.
Dexamethasone; Tobramycin (multiple Reference Listed Drugs).
Diclofenac sodium.
Econazole nitrate.
Fluorouracil (multiple Reference Listed Drugs).
Fluticasone propionate.
Haloperidol.
Imiquimod (multiple Reference Listed Drugs).
Ingenol mebutate (multiple Reference Listed Drugs).
Ketoconazole.
Lumacaftor; Ivacaftor.
Miconazole.
Mometasone furoate monohydrate (multiple Reference Listed Drugs).
Oxiconazole Nitrate (multiple Reference Listed Drugs).
Tazarotene (multiple Reference Listed Drugs).
Terbinafine hydrochloride.
Treprostinil diethanolamine (multiple Reference Listed Drugs).
Tretinoin.
Triamcinolone acetonide.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
documents related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the current thinking of FDA on, among 
other things, the product-specific design of BE studies to support 
ANDAs. They do not establish any rights for any person and are 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.

IV. Electronic Access

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

    Dated: February 19, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03129 Filed 2-22-19; 8:45 am]
 BILLING CODE 4164-01-P
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