Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 34851-34853 [2018-15735]

Download as PDF Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices YellowBook@gao.gov or telephonically to 202–512–9535. Authority: Pub. L. 67–13, 42 Stat. 20 (June 10, 1921). James R. Dalkin, Director, Financial Management and Assurance, U.S. Government Accountability Office. [FR Doc. 2018–15629 Filed 7–20–18; 8:45 am] BILLING CODE 1610–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Notice of Hearing: Reconsideration of Disapproval Minnesota Medicaid State Plan Amendment (SPA) 12–0014–B Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of hearing: Reconsideration of disapproval. AGENCY: This notice announces an administrative hearing to be held on August 21, 2018, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children’s Health Insurance Program Services, Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, Chicago, Illinois 60601–5519, to reconsider CMS’s decision to disapprove Minnesota’s Medicaid SPA 12–0014–B. DATES: Requests to participate in the hearing as a party must be received by the presiding officer by August 7, 2018. FOR FURTHER INFORMATION CONTACT: Benjamin R. Cohen, Presiding Officer, CMS, 2520 Lord Baltimore Drive, Suite L, Baltimore, Maryland 21244, Telephone: (410) 786–3169. SUPPLEMENTARY INFORMATION: This notice announces an administrative hearing to reconsider CMS’s decision to disapprove Minnesota’s Medicaid state plan amendment (SPA) 12–0014–B, which was submitted to the Centers for Medicare & Medicaid Services (CMS) on April 1, 2012 and disapproved on April 27, 2018. This SPA requested CMS approval to limit application of a resource disregard, in determining eligibility for several optional eligibility groups covered under its state plan, to individuals who were previously enrolled in the eligibility group described in section 1902(a)(10)(A)(ii)(XIII) (sometimes referred to as the ‘‘working disability’’ group) for at least 24 consecutive amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:59 Jul 20, 2018 Jkt 244001 34851 months and who have an ineligible spouse. The issues to be considered at the hearing are whether Minnesota SPA 12– 0014–B is inconsistent with the requirements of: • Section 1902(a)(17) of the Act and 42 CFR 435.601(d)(4), which require that states apply comparable eligibility standards and methodologies within eligibility groups. Section 1116 of the Act and federal regulations at 42 CFR part 430 establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a state plan or plan amendment. CMS is required to publish in the Federal Register a copy of the notice to a state Medicaid agency that informs the agency of the time and place of the hearing, and the issues to be considered. If we subsequently notify the state Medicaid agency of additional issues that will be considered at the hearing, we will also publish that notice in the Federal Register. Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as amicus curiae must petition the presiding officer before the hearing begins in accordance with the requirements contained at 42 CFR 430.76(c). If the hearing is later rescheduled, the presiding officer will notify all participants. The notice to Minnesota announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows: present any problems, please contact Mr. Cohen at (410) 786–3169. In order to facilitate any communication that may be necessary between the parties prior to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. If the hearing date is not acceptable, Mr. Cohen can set another date mutually agreeable to the parties. The hearing will be governed by the procedures prescribed by federal regulations at 42 CFR part 430. SPA 12–0014–B proposed to limit application of a resource disregard, in determining eligibility for several optional eligibility groups covered under its state plan, to individuals who were previously enrolled in the eligibility group described in section 1902(a)(10)(A)(ii)(XIII) (sometimes referred to as the ‘‘working disability’’ group) for at least 24 consecutive months and who have an ineligible spouse. The issues to be considered at the hearing are whether Minnesota SPA 12–0014–B is inconsistent with the requirements of: • Section 1902(a)(17) of the Act and 42 CFR § 435.601(d)(4), which require that states apply comparable eligibility standards and methodologies within eligibility groups. In the event that CMS and the state come to agreement on resolution of the issues which formed the basis for disapproval, this SPA may be moved to approval prior to the scheduled hearing. Sincerely, Seema Verma, Administrator, cc: Benjamin R. Cohen Section 1116 of the Social Security Act (42 U.S.C. 1316; 42 CFR 430.18). (Catalog of Federal Domestic Assistance program No. 13.714. Medicaid Assistance Program) Ms. Marie Zimmerman Medicaid Director State of Minnesota, Department of Human Services 540 Cedar Street, P.O. Box 64983 St. Paul, MN 55167 Dear Ms. Zimmerman I am responding to your request for reconsideration of the decision to disapprove Minnesota’s State Plan amendment (SPA) 12–0014–B, which was submitted to the Centers for Medicare & Medicaid Services (CMS) on April 1, 2012, and disapproved on April 27, 2018. I am scheduling a hearing on your request for reconsideration to be held on August 21, 2018, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children’s Health Insurance Program Services, Chicago Regional Office, 233 N. Michigan Avenue, Suite 600 Chicago, Illinois 60601–5519. I am designating Mr. Benjamin R. Cohen as the presiding officer. If these arrangements [FR Doc. 2018–15681 Filed 7–20–18; 8:45 am] PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Dated: July 17, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. BILLING CODE 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 SUMMARY: E:\FR\FM\23JYN1.SGM 23JYN1 34852 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 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 September 21, 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: DATES: 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’’). amozie on DSK3GDR082PROD with NOTICES1 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 VerDate Sep<11>2014 17:59 Jul 20, 2018 Jkt 244001 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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 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 9, 2018. 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 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 Acrivastine; Pseudoephedrine hydrochloride. E:\FR\FM\23JYN1.SGM 23JYN1 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 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—Continued Beclomethasone dipropionate. Betamethasone dipropionate. Betrixaban. Ciprofloxacin. Deferasirox. Dexamethasone; Neomycin sulfate; Polymyxin b sulfate. Epinephrine. Ethinyl estradiol; Norethindrone acetate. Finafloxacin. Fluocinolone acetonide. Loteprednol etabonate. Mecamylamine hydrochloride. Methscopolamine bromide. Methylphenidate. Metyrosine. Moxifloxacin hydrochloride. Nebivolol hydrochloride; Valsartan. Nimodipine. Nitisinone. Omeprazole. Rifapentine. Ritonavir. Sodium polystyrene sulfonate. Triamcinolone acetonide. Valbenazine tosylate. 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 amozie on DSK3GDR082PROD with NOTICES1 Abiraterone acetate. Dapagliflozin propanediol; Metformin hydrochloride. Diclofenac sodium. Donepezil hydrochloride; Memantine hydrochloride. Esomeprazole strontium. Ethosuximide. Glatiramer acetate. Hydrocodone bitartrate. Lansoprazole. Latanoprost. Leucovorin calcium. Methylphenidate hydrochloride. Morphine sulfate; Naltrexone hydrochloride. Nisoldipine. Oxycodone hydrochloride. Ticagrelor. 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 VerDate Sep<11>2014 17:59 Jul 20, 2018 Jkt 244001 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: July 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–15735 Filed 7–20–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–17– 031: Role of Age-Associated Metabolic Changes in Alzhemimer’s Disease. Date: July 31, 2018. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435–1246, edwardss@csr.nih.gov. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 34853 This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: July 17, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–15605 Filed 7–20–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Urologic and Urogynecologic Applications. Date: July 20, 2018. Time: 10:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ganesan Ramesh, Ph.D., Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, 301–827–5467, ganesan.ramesh@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Review of Aging Applications. Date: August 13, 2018. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Pages 34851-34853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15735]


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

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

[[Page 34852]]

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 September 21, 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 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: 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 February 9, 2018. 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 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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Acrivastine; Pseudoephedrine hydrochloride.

[[Page 34853]]

 
Beclomethasone dipropionate.
Betamethasone dipropionate.
Betrixaban.
Ciprofloxacin.
Deferasirox.
Dexamethasone; Neomycin sulfate; Polymyxin b sulfate.
Epinephrine.
Ethinyl estradiol; Norethindrone acetate.
Finafloxacin.
Fluocinolone acetonide.
Loteprednol etabonate.
Mecamylamine hydrochloride.
Methscopolamine bromide.
Methylphenidate.
Metyrosine.
Moxifloxacin hydrochloride.
Nebivolol hydrochloride; Valsartan.
Nimodipine.
Nitisinone.
Omeprazole.
Rifapentine.
Ritonavir.
Sodium polystyrene sulfonate.
Triamcinolone acetonide.
Valbenazine tosylate.
------------------------------------------------------------------------

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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Abiraterone acetate.
Dapagliflozin propanediol; Metformin hydrochloride.
Diclofenac sodium.
Donepezil hydrochloride; Memantine hydrochloride.
Esomeprazole strontium.
Ethosuximide.
Glatiramer acetate.
Hydrocodone bitartrate.
Lansoprazole.
Latanoprost.
Leucovorin calcium.
Methylphenidate hydrochloride.
Morphine sulfate; Naltrexone hydrochloride.
Nisoldipine.
Oxycodone hydrochloride.
Ticagrelor.
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: July 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15735 Filed 7-20-18; 8:45 am]
 BILLING CODE 4164-01-P
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