83_FR_5813 83 FR 5785 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

83 FR 5785 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range5785-5786
FR Document2018-02667

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.

Federal Register, Volume 83 Issue 28 (Friday, February 9, 2018) 
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5785-5786]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02667]


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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 10, 2018 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

[[Page 5786]]

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 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: Xiaoqiu Tang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

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 October 20, 2017. 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
------------------------------------------------------------------------
 
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Alcaftadine.
Amitriptyline hydrochloride; Chlordiazepoxide.
Amphetamine sulfate.
Barium sulfate (multiple Reference Listed Drugs).
Betamethasone dipropionate.
Bimatoprost (multiple Reference Listed Drugs).
Bupivacaine.
Buprenorphine hydrochloride.
Cabozantinib S-malate (multiple Reference Listed Drugs).
Crisaborole.
Desonide.
Doxycycline hyclate.
Fluocinonide.
Hydrocortisone valerate.
Ixazomib citrate.
Ketoconazole.
Leuprolide acetate; Norethindrone acetate.
Levetiracetam.
Levocetirizine dihydrochloride.
Loteprednol etabonate.
Mebendazole.
Naldemedine tosylate.
Naproxen sodium; Pseudoephedrine hydrochloride.
Niraparib tosylate.
Olopatadine hydrochloride.
Prasterone.
Rucaparib camsylate.
Safinamide mesylate.
Simvastatin; Sitagliptin phosphate.
Soybean oil (multiple Reference Listed Drugs).
------------------------------------------------------------------------

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
------------------------------------------------------------------------
 
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Aspirin; omeprazole.
Cysteamine bitartrate.
Daclatasvir dihydrochloride.
Dexlansoprazole (multiple Reference Listed Drugs).
Esomeprazole magnesium (multiple Reference Listed Drugs).
Felbamate (multiple Reference Listed Drugs).
Fluconazole.
Gatifloxacin.
Gentamicin sulfate.
Ketorolac tromethamine.
Lansoprazole.
Loteprednol etabonate.
Morphine sulfate.
Naloxegol oxalate.
Oxycodone.
Pantoprazole sodium.
Potassium citrate.
Sulfamethoxazole; Trimethoprim.
Triamcinolone acetonide.
------------------------------------------------------------------------

    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. 
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 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02667 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5785 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Total 21 CFR section responses per burden per respondents responses hours respondent response 310.305(e)(2) ....................................................................... 1 1 1 1 1 314.80(g)(2) ......................................................................... 5 1 5 1 5 329.100(c)(2) ........................................................................ 1 1 1 1 1 600.80(h)(2) ......................................................................... 5 1 5 1 5 600.81(b)(2) ......................................................................... 1 1 1 1 1 Total .............................................................................. ........................ ........................ ........................ ........................ 13 1 There are no capital or operating and maintenance costs associated with this collection of information. In table 1, we estimate the burden Recommendations for Specific • Mail/Hand delivery/Courier (for associated with the submission of Products’’ that explained the process written/paper submissions): Dockets waiver requests for postmarketing safety that would be used to make product- Management Staff (HFA–305), Food and reports in electronic format under specific guidances available to the Drug Administration, 5630 Fishers §§ 310.305(e)(2), 314.80(g)(2), public on FDA’s website. The guidances Lane, Rm. 1061, Rockville, MD 20852. 329.100(c)(2), 600.80(h)(2), and identified in this notice were developed • For written/paper comments 600.81(b)(2). We expect few waiver using the process described in that submitted to the Dockets Management requests. We estimate only one guidance. Staff, FDA will post your comment, as manufacturer will request a waiver well as any attachments, except for annually under §§ 310.305(e)(2), DATES: Submit either electronic or information submitted, marked and 329.100(c)(2), and 600.81(b)(2), and written comments on the draft guidance identified, as confidential, if submitted approximately five manufacturers will by April 10, 2018 to ensure that the as detailed in ‘‘Instructions.’’ request waivers annually under Agency considers your comment on this Instructions: All submissions received §§ 314.80(g)(2) and 600.80(h)(2). We draft guidance before it begins work on must include the Docket No. FDA– estimate that each waiver request takes the final version of the guidance. 2007–D–0369 for ‘‘Product-Specific 1 hour to prepare and submit. The ADDRESSES: You may submit comments Guidances; Draft and Revised Draft burden for this information collection on any guidance at any time as follows: Guidances for Industry.’’ Received has not increased since the last comments will be placed in the docket Electronic Submissions and, except for those submitted as collection. Submit electronic comments in the ‘‘Confidential Submissions,’’ publicly Dated: February 5, 2018. viewable at https://www.regulations.gov Leslie Kux, following way: or at the Dockets Management Staff Associate Commissioner for Policy. • Federal eRulemaking Portal: between 9 a.m. and 4 p.m., Monday https://www.regulations.gov. Follow the [FR Doc. 2018–02589 Filed 2–8–18; 8:45 am] through Friday. instructions for submitting comments. • Confidential Submissions—To BILLING CODE 4164–01–P Comments submitted electronically, submit a comment with confidential including attachments, to https:// information that you do not wish to be DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to made publicly available, submit your HUMAN SERVICES the docket unchanged. Because your comments only as a written/paper comment will be made public, you are submission. You should submit two Food and Drug Administration solely responsible for ensuring that your copies total. One copy will include the comment does not include any information you claim to be confidential [Docket No. FDA–2007–D–0369] confidential information that you or a with a heading or cover note that states third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS Product-Specific Guidances; Draft and such as medical information, your or Revised Draft Guidances for Industry; CONFIDENTIAL INFORMATION.’’ The anyone else’s Social Security number, or Agency will review this copy, including Availability confidential business information, such the claimed confidential information, in AGENCY: Food and Drug Administration, as a manufacturing process. Please note its consideration of comments. The HHS. that if you include your name, contact second copy, which will have the information, or other information that claimed confidential information ACTION: Notice of availability. identifies you in the body of your redacted/blacked out, will be available SUMMARY: The Food and Drug comments, that information will be for public viewing and posted on Administration (FDA or Agency) is posted on https://www.regulations.gov. https://www.regulations.gov. Submit announcing the availability of • If you want to submit a comment both copies to the Dockets Management additional draft and revised draft with confidential information that you Staff. If you do not wish your name and product-specific guidances. The do not wish to be made available to the contact information to be made publicly guidances provide product-specific public, submit the comment as a available, you can provide this sradovich on DSK3GMQ082PROD with NOTICES recommendations on, among other written/paper submission and in the information on the cover sheet and not things, the design of bioequivalence manner detailed (see ‘‘Written/Paper in the body of your comments and you (BE) studies to support abbreviated new Submissions’’ and ‘‘Instructions’’). must identify this information as drug applications (ANDAs). In the ‘‘confidential.’’ Any information marked Written/Paper Submissions Federal Register of June 11, 2010, FDA as ‘‘confidential’’ will not be disclosed announced the availability of a guidance Submit written/paper submissions as except in accordance with 21 CFR 10.20 for industry entitled ‘‘Bioequivalence follows: and other applicable disclosure law. For VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1

5786 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices more information about FDA’s posting received and either publishes final TABLE 2—REVISED DRAFT of comments to public dockets, see 80 guidances or publishes revised draft PRODUCT-—Continued FR 56469, September 18, 2015, or access guidances for comment. Guidances were SPECIFIC GUIDANCES FOR DRUG the information at: https://www.gpo.gov/ last announced in the Federal Register fdsys/pkg/FR-2015-09-18/pdf/2015- on October 20, 2017. This notice PRODUCTS 23389.pdf. announces draft product-specific Cysteamine bitartrate. Docket: For access to the docket to guidances, either new or revised, that Daclatasvir dihydrochloride. read background documents or the are posted on FDA’s website. Dexlansoprazole (multiple Reference Listed electronic and written/paper comments Drugs). II. Drug Products for Which New Draft received, go to https:// Esomeprazole magnesium (multiple Ref- Product-Specific Guidances Are www.regulations.gov and insert the erence Listed Drugs). Available docket number, found in brackets in the Felbamate (multiple Reference Listed Drugs). heading of this document, into the FDA is announcing the availability of Fluconazole. ‘‘Search’’ box and follow the prompts new draft product-specific guidances for Gatifloxacin. and/or go to the Dockets Management industry for drug products containing Gentamicin sulfate. Staff, 5630 Fishers Lane, Rm. 1061, the following active ingredients: Ketorolac tromethamine. Rockville, MD 20852. Lansoprazole. You may submit comments on any TABLE 1—NEW DRAFT PRODUCT- Loteprednol etabonate. guidance at any time (see 21 CFR SPECIFIC GUIDANCES FOR DRUG Morphine sulfate. 10.115(g)(5)). PRODUCTS Naloxegol oxalate. Submit written requests for single Oxycodone. copies of the draft guidances to the Alcaftadine. Pantoprazole sodium. Division of Drug Information, Center for Amitriptyline hydrochloride; Chlordiazepoxide. Potassium citrate. Drug Evaluation and Research, Food Amphetamine sulfate. Sulfamethoxazole; Trimethoprim. and Drug Administration, 10001 New Barium sulfate (multiple Reference Listed Triamcinolone acetonide. Hampshire Ave., Hillandale Building, Drugs). Betamethasone dipropionate. 4th Floor, Silver Spring, MD 20993– For a complete history of previously Bimatoprost (multiple Reference Listed 0002. Send one self-addressed adhesive Drugs). published Federal Register notices label to assist that office in processing Bupivacaine. related to product-specific guidances, go your requests. See the SUPPLEMENTARY Buprenorphine hydrochloride. to https://www.regulations.gov and INFORMATION section for electronic Cabozantinib S-malate (multiple Reference enter Docket No. FDA–2007–D–0369. access to the draft guidance documents. Listed Drugs). Crisaborole. These draft guidances are being FOR FURTHER INFORMATION CONTACT: issued consistent with FDA’s good Desonide. Xiaoqiu Tang, Center for Drug Doxycycline hyclate. guidance practices regulation (21 CFR Evaluation and Research, Food and Fluocinonide. 10.115). These draft guidances, when Drug Administration, 10903 New Hydrocortisone valerate. finalized, will represent the current Hampshire Ave., Bldg. 75, Rm. 4730, Ixazomib citrate. thinking of FDA on, among other things, Silver Spring, MD 20993–0002, 301– Ketoconazole. Leuprolide acetate; Norethindrone acetate. the product-specific design of BE 796–5850. Levetiracetam. studies to support ANDAs. They do not SUPPLEMENTARY INFORMATION: Levocetirizine dihydrochloride. establish any rights for any person and I. Background Loteprednol etabonate. are not binding on FDA or the public. Mebendazole. You can use an alternative approach if In the Federal Register of June 11, Naldemedine tosylate. 2010 (75 FR 33311), FDA announced the it satisfies the requirements of the Naproxen sodium; Pseudoephedrine hydro- availability of a guidance for industry chloride. applicable statutes and regulations. This entitled ‘‘Bioequivalence Niraparib tosylate. guidance is not subject to Executive Recommendations for Specific Olopatadine hydrochloride. Order 12866. Products’’ that explained the process Prasterone. Rucaparib camsylate. IV. Electronic Access that would be used to make product- Safinamide mesylate. specific guidances available to the Simvastatin; Sitagliptin phosphate. Persons with access to the internet public on FDA’s website at https:// Soybean oil (multiple Reference Listed may obtain the draft guidances at either www.fda.gov/Drugs/ Drugs). https://www.fda.gov/Drugs/Guidance GuidanceComplianceRegulatory ComplianceRegulatoryInformation/ Information/Guidances/default.htm. III. Drug Products for Which Revised Guidances/default.htm or https:// As described in that guidance, FDA Draft Product-Specific Guidances Are www.regulations.gov. adopted this process as a means to Available develop and disseminate product- Dated: February 5, 2018. specific guidances and provide a FDA is announcing the availability of Leslie Kux, meaningful opportunity for the public to revised draft product-specific guidances Associate Commissioner for Policy. consider and comment on those for industry for drug products [FR Doc. 2018–02667 Filed 2–8–18; 8:45 am] guidances. Under that process, draft containing the following active sradovich on DSK3GMQ082PROD with NOTICES BILLING CODE 4164–01–P guidances are posted on FDA’s website ingredients: and announced periodically in the Federal Register. The public is TABLE 2—REVISED DRAFT PRODUCT- encouraged to submit comments on SPECIFIC GUIDANCES FOR DRUG those recommendations within 60 days PRODUCTS of their announcement in the Federal Register. FDA considers any comments Aspirin; omeprazole. VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 E:\FR\FM\09FEN1.SGM 09FEN1


Document Created: 2018-02-09 00:12:16
Document Modified: 2018-02-09 00:12:16
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.
DatesSubmit either electronic or written comments on the draft guidance by April 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactXiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850.
FR Citation83 FR 5785 
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