Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 22668-22669 [2017-09961]

Download as PDF 22668 Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices Synopsis: The Agreement authorizes HLAG to sell space to CMA CGM on its MGX service in the trade between ports on the U.S. Gulf Coast on the one hand, and ports on the Gulf Coast of Mexico and in Italy, Spain and Jamaica on the other hand. Agreement No.: 012484. Title: Port of New York & New Jersey/ OCEMA Discussion Agreement. Parties: Port Authority of New York and New Jersey and the Ocean Carrier Equipment Management Association, Inc., FMC Agreement No. 011284 (OCEMA). Filing Party: Sam Ruda; Port Authority of NY & NJ; 4 World Trade Center; 150 Greenwich Street—17th Floor; New York, NY 10007. Synopsis: The Agreement authorizes the Port of New York and New Jersey and OCEMA to collect and exchange information, discuss, and reach agreement upon matters relating to the Cargo Facility Charge levied by the Port Authority of New York and New Jersey. By Order of the Federal Maritime Commission. Dated: May 12, 2017. Rachel E. Dickon, Assistant Secretary. [FR Doc. 2017–09987 Filed 5–16–17; 8:45 am] BILLING CODE 6731–AA–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 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 Web site. The guidances identified in this notice were nlaroche on DSK30NT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:18 May 16, 2017 Jkt 241001 developed using the process described in that guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment(s) on these draft guidances before it begins work on the final version of such guidances, submit either electronic or written comments on the draft guidance by July 17, 2017. ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 E:\FR\FM\17MYN1.SGM 17MYN1 Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices TABLE 1—NEW DRAFT PRODUCT-SPE- Guidances/default.htm or https:// CIFIC GUIDANCES FOR DRUG PROD- www.regulations.gov. UCTS—Continued Dated: May 11, 2017. 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 productspecific guidances available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/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 Web site 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 December 23, 2016 (81 FR 94394). This notice announces draft productspecific guidances, either new or revised, that are posted on FDA’s Web site. Hydrocortisone Hydrocortisone butyrate Linagliptin; Metformin hydrochloride Lorcaserin hydrochloride Methylnaltrexone bromide Nitroglycerin Nystatin; Triamcinolone acetonide (multiple reference listed drugs) Oxymetazoline hydrochloride; Tetracaine hydrochloride Sofosbuvir; Velpatasvir Venetoclax FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients: nlaroche on DSK30NT082PROD with NOTICES VerDate Sep<11>2014 15:18 May 16, 2017 Acamprosate calcium Apixaban Bexarotene Calcium acetate (multiple reference listed drugs) Deferiprone Dolutegravir sodium Emtricitabine; Tenofovir disoproxil fumarate Fingolimod Lanthanum carbonate Nevirapine Phenytoin (multiple reference listed drugs) Propafenone hydrochloride Trospium chloride (multiple reference listed drugs) IV. Electronic Access Jkt 241001 [FR Doc. 2017–09961 Filed 5–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/ Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. TABLE 2—REVISED DRAFT PRODUCT- SUMMARY: The Food and Drug SPECIFIC GUIDANCES FOR DRUG Administration (FDA or Agency) has PRODUCTS determined that the drug product listed 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 TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current thinking of FDA on, among other things, UCTS the product-specific design of BE studies to support ANDAs. They do not Acetylcysteine establish any rights for any person and Amphetamine are not binding on FDA or the public. Aprepitant You can use an alternative approach if Azelastine hydrochloride Bisacodyl; polyethylene glycol 3350; potasit satisfies the requirements of the sium chloride; sodium bicarbonate; sodium applicable statutes and regulations. Clidinium Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [Docket No. FDA–2017–N–2364] III. Drug Products for Which Revised Draft Product-Specific Guidances are Available II. Drug Products for Which New Draft Product-Specific Guidances are Available FDA is announcing the availability of a new draft product-specific guidances for industry for drug products containing the following active ingredients: chloride Carbidopa; levodopa Chlordiazepoxide hydrochloride; bromide Clonazepam Edoxaban tosylate Gentamicin sulfate 22669 Persons with access to the Internet may obtain the draft guidances at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 in this document was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. E:\FR\FM\17MYN1.SGM 17MYN1

Agencies

[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Pages 22668-22669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09961]


=======================================================================
-----------------------------------------------------------------------

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 Web site. 
The guidances identified in this notice were developed using the 
process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment(s) on 
these draft guidances before it begins work on the final version of 
such guidances, submit either electronic or written comments on the 
draft guidance by July 17, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 Division of 
Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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

[[Page 22669]]

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 Web site 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 Web 
site 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 December 23, 2016 (81 FR 94394). This notice 
announces draft product-specific guidances, either new or revised, that 
are posted on FDA's Web site.

II. Drug Products for Which New Draft Product-Specific Guidances are 
Available

    FDA is announcing the availability of a 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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Acetylcysteine
Amphetamine
Aprepitant
Azelastine hydrochloride
Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium
 bicarbonate; sodium chloride
Carbidopa; levodopa
Chlordiazepoxide hydrochloride; Clidinium bromide
Clonazepam
Edoxaban tosylate
Gentamicin sulfate
Hydrocortisone
Hydrocortisone butyrate
Linagliptin; Metformin hydrochloride
Lorcaserin hydrochloride
Methylnaltrexone bromide
Nitroglycerin
Nystatin; Triamcinolone acetonide (multiple reference listed drugs)
Oxymetazoline hydrochloride; Tetracaine hydrochloride
Sofosbuvir; Velpatasvir
Venetoclax
------------------------------------------------------------------------

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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Acamprosate calcium
Apixaban
Bexarotene
Calcium acetate (multiple reference listed drugs)
Deferiprone
Dolutegravir sodium
Emtricitabine; Tenofovir disoproxil fumarate
Fingolimod
Lanthanum carbonate
Nevirapine
Phenytoin (multiple reference listed drugs)
Propafenone hydrochloride
Trospium chloride (multiple reference listed drugs)
------------------------------------------------------------------------

    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.

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 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09961 Filed 5-16-17; 8:45 am]
 BILLING CODE 4164-01-P