Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 22131-22132 [2019-10165]

Download as PDF 22131 Federal Register / Vol. 84, No. 95 / Thursday, May 16, 2019 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents Annual number of responses per respondent Average burden hours per response Annual burden hours Tribal MIECHV Form 1 .................................................................................... 25 1 500 12,500 Estimated Total Annual Burden Hours: 12,500. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–10167 Filed 5–15–19; 8:45 am] BILLING CODE 4184–77–P 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. 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 khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:22 May 15, 2019 Jkt 247001 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. DATES: Submit either electronic or written comments on the draft guidance by July 15, 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 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. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 • 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:// E:\FR\FM\16MYN1.SGM 16MYN1 22132 Federal Register / Vol. 84, No. 95 / Thursday, May 16, 2019 / Notices 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: khammond on DSKBBV9HB2PROD with NOTICES 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 February 25, 2019 (84 FR 6005). This notice announces draft product-specific guidances, either new or revised, that are posted on FDA’s website. VerDate Sep<11>2014 17:22 May 15, 2019 Jkt 247001 II. Drug Products For Which New Draft Product-Specific Guidances Are Available to https://www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft guidances are being issued consistent with FDA’s good FDA is announcing the availability of guidance practices regulation (21 CFR new draft product-specific guidances for 10.115). These draft guidances, when industry for drug products containing finalized, will represent the current the following active ingredients: thinking of FDA on, among other things, the product-specific design of BE TABLE 1—NEW DRAFT PRODUCT-SPE- studies to support ANDAs. They do not CIFIC GUIDANCES FOR DRUG PROD- establish any rights for any person and UCTS are not binding on FDA or the public. You can use an alternative approach if Acetaminophen; Codeine phosphate it satisfies the requirements of the Apalutamide applicable statutes and regulations. Beclomethasone dipropionate These guidances are not subject to Benoxinate hydrochloride; Fluorescein soExecutive Order 12866. dium Bictegravir sodium; Emtricitabine; Tenofovir alafenamide fumarate Brimonidine tartrate Budesonide Chlorpheniramine maleate; Ibuprofen; Pseudoephedrine hydrochloride Cyclosporine Desloratadine; Pseudoephedrine sulfate Desmopressin acetate Efavirenz; Lamivudine; Tenofovir disoproxil fumarate (multiple Reference Listed Drugs) Eravacycline dihydrochloride Estradiol; levonorgestrel Fluticasone furoate Fluticasone propionate Fluticasone propionate; Salmeterol xinafoate Fosnetupitant chloride hydrochloride; Palonosetron hydrochloride Halcinonide Lamivudine; Tenofovir disoproxil fumarate Naproxen Omeprazole magnesium Primidone Timolol maleate Tobramycin 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 PRODUCTSPECIFIC GUIDANCES FOR DRUG PRODUCTS Azelaic acid (multiple Reference Drugs) Betaxolol hydrochloride Brimonidine tartrate; Brinzolamide Brinzolamide Fosfomycin tromethamine Ivermectin Methylprednisolone Prednisolone acetate Tofacitinib citrate Listed For a complete history of previously published Federal Register notices related to product-specific guidances, go PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 IV. Electronic Access Persons with access to the internet may obtain the draft guidances at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: May 13, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–10165 Filed 5–15–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0458 Revision] Agency Information Collection Request; 30-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed revision of a collection for public comment. SUMMARY: Comments on the ICR must be received on or before June 17, 2019. ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Sherrette Funn, Sherrette.Funn@hhs.gov or (202) 795–7714. When submitting comments or requesting information, please include the document identifier OS–0990–0458 Revision, and project title for reference. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any DATES: E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 84, Number 95 (Thursday, May 16, 2019)]
[Notices]
[Pages 22131-22132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10165]


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

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 July 15, 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 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://

[[Page 22132]]

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 February 25, 2019 (84 FR 6005). 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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Acetaminophen; Codeine phosphate
Apalutamide
Beclomethasone dipropionate
Benoxinate hydrochloride; Fluorescein sodium
Bictegravir sodium; Emtricitabine; Tenofovir alafenamide fumarate
Brimonidine tartrate
Budesonide
Chlorpheniramine maleate; Ibuprofen; Pseudoephedrine hydrochloride
Cyclosporine
Desloratadine; Pseudoephedrine sulfate
Desmopressin acetate
Efavirenz; Lamivudine; Tenofovir disoproxil fumarate (multiple Reference
 Listed Drugs)
Eravacycline dihydrochloride
Estradiol; levonorgestrel
Fluticasone furoate
Fluticasone propionate
Fluticasone propionate; Salmeterol xinafoate
Fosnetupitant chloride hydrochloride; Palonosetron hydrochloride
Halcinonide
Lamivudine; Tenofovir disoproxil fumarate
Naproxen
Omeprazole magnesium
Primidone
Timolol maleate
Tobramycin
------------------------------------------------------------------------

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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Azelaic acid (multiple Reference Listed Drugs)
Betaxolol hydrochloride
Brimonidine tartrate; Brinzolamide
Brinzolamide
Fosfomycin tromethamine
Ivermectin
Methylprednisolone
Prednisolone acetate
Tofacitinib citrate
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices 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. 
These guidances are 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: May 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10165 Filed 5-15-19; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.