83 FR 34851 - 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 141 (July 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 141 (July 23, 2018)
| Page Range | 34851-34853 | |
| FR Document | 2018-15735 |
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)] [Notices] [Pages 34851-34853] From the Federal Register Online [www.thefederalregister.org] [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 DATES: Submit either electronic or written comments on the draft guidance by September 21, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.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 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
![Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 34851
YellowBook@gao.gov or telephonically months and who have an ineligible present any problems, please contact Mr.
to 202–512–9535. spouse. Cohen at (410) 786–3169. In order to
The issues to be considered at the facilitate any communication that may be
Authority: Pub. L. 67–13, 42 Stat. 20 (June necessary between the parties prior to the
10, 1921). hearing are whether Minnesota SPA 12–
hearing, please notify the presiding officer to
0014–B is inconsistent with the indicate acceptability of the hearing date that
James R. Dalkin, requirements of: has been scheduled and provide names of the
Director, Financial Management and • Section 1902(a)(17) of the Act and individuals who will represent the State at
Assurance, U.S. Government Accountability 42 CFR 435.601(d)(4), which require the hearing. If the hearing date is not
Office. that states apply comparable eligibility acceptable, Mr. Cohen can set another date
[FR Doc. 2018–15629 Filed 7–20–18; 8:45 am] standards and methodologies within mutually agreeable to the parties. The
BILLING CODE 1610–02–P eligibility groups. hearing will be governed by the procedures
Section 1116 of the Act and federal prescribed by federal regulations at 42 CFR
regulations at 42 CFR part 430 establish part 430.
SPA 12–0014–B proposed to limit
Department procedures that provide an
DEPARTMENT OF HEALTH AND application of a resource disregard, in
administrative hearing for determining eligibility for several optional
HUMAN SERVICES reconsideration of a disapproval of a eligibility groups covered under its state
Centers for Medicare & Medicaid state plan or plan amendment. CMS is plan, to individuals who were previously
Services required to publish in the Federal enrolled in the eligibility group described in
Register a copy of the notice to a state section 1902(a)(10)(A)(ii)(XIII) (sometimes
Notice of Hearing: Reconsideration of Medicaid agency that informs the referred to as the ‘‘working disability’’ group)
agency of the time and place of the for at least 24 consecutive months and who
Disapproval Minnesota Medicaid State
hearing, and the issues to be considered. have an ineligible spouse.
Plan Amendment (SPA) 12–0014–B The issues to be considered at the hearing
If we subsequently notify the state
AGENCY: Centers for Medicare & are whether Minnesota SPA 12–0014–B is
Medicaid agency of additional issues inconsistent with the requirements of:
Medicaid Services (CMS), Department that will be considered at the hearing, • Section 1902(a)(17) of the Act and 42
of Health and Human Services (HHS). we will also publish that notice in the CFR § 435.601(d)(4), which require that states
ACTION: Notice of hearing: Federal Register. apply comparable eligibility standards and
Reconsideration of disapproval. Any individual or group that wants to methodologies within eligibility groups.
participate in the hearing as a party In the event that CMS and the state come
SUMMARY: This notice announces an must petition the presiding officer to agreement on resolution of the issues
administrative hearing to be held on within 15 days after publication of this which formed the basis for disapproval, this
August 21, 2018, at the Department of notice, in accordance with the SPA may be moved to approval prior to the
Health and Human Services, Centers for scheduled hearing.
requirements contained at 42 CFR
Medicare & Medicaid Services, Division 430.76(b)(2). Any interested person or Sincerely,
of Medicaid & Children’s Health Seema Verma,
organization that wants to participate as
Insurance Program Services, Chicago amicus curiae must petition the Administrator,
Regional Office, 233 N. Michigan presiding officer before the hearing cc: Benjamin R. Cohen
Avenue, Suite 600, Chicago, Illinois begins in accordance with the Section 1116 of the Social Security Act (42
60601–5519, to reconsider CMS’s requirements contained at 42 CFR U.S.C. 1316; 42 CFR 430.18).
decision to disapprove Minnesota’s 430.76(c). If the hearing is later (Catalog of Federal Domestic Assistance
Medicaid SPA 12–0014–B. rescheduled, the presiding officer will program No. 13.714. Medicaid Assistance
DATES: Requests to participate in the notify all participants. Program)
hearing as a party must be received by The notice to Minnesota announcing Dated: July 17, 2018.
the presiding officer by August 7, 2018. an administrative hearing to reconsider Seema Verma,
FOR FURTHER INFORMATION CONTACT: the disapproval of its SPA reads as Administrator, Centers for Medicare &
Benjamin R. Cohen, Presiding Officer, follows: Medicaid Services.
CMS, 2520 Lord Baltimore Drive, Suite Ms. Marie Zimmerman [FR Doc. 2018–15681 Filed 7–20–18; 8:45 am]
L, Baltimore, Maryland 21244, Medicaid Director BILLING CODE P
Telephone: (410) 786–3169. State of Minnesota, Department of Human
Services
SUPPLEMENTARY INFORMATION: This
540 Cedar Street, P.O. Box 64983 DEPARTMENT OF HEALTH AND
notice announces an administrative St. Paul, MN 55167
hearing to reconsider CMS’s decision to HUMAN SERVICES
Dear Ms. Zimmerman
disapprove Minnesota’s Medicaid state
I am responding to your request for Food and Drug Administration
plan amendment (SPA) 12–0014–B,
reconsideration of the decision to disapprove
which was submitted to the Centers for Minnesota’s State Plan amendment (SPA)
[Docket No. FDA–2007–D–0369]
Medicare & Medicaid Services (CMS) on 12–0014–B, which was submitted to the
April 1, 2012 and disapproved on April Product-Specific Guidances; Draft and
Centers for Medicare & Medicaid Services
27, 2018. This SPA requested CMS (CMS) on April 1, 2012, and disapproved on Revised Draft Guidances for Industry;
approval to limit application of a April 27, 2018. I am scheduling a hearing on Availability
resource disregard, in determining your request for reconsideration to be held on AGENCY: Food and Drug Administration,
eligibility for several optional eligibility August 21, 2018, at the Department of Health
HHS.
amozie on DSK3GDR082PROD with NOTICES1
groups covered under its state plan, to and Human Services, Centers for Medicare &
Medicaid Services, Division of Medicaid & ACTION: Notice of availability.
individuals who were previously
Children’s Health Insurance Program
enrolled in the eligibility group Services, Chicago Regional Office, 233 N. SUMMARY: The Food and Drug
described in section Michigan Avenue, Suite 600 Chicago, Illinois Administration (FDA or Agency) is
1902(a)(10)(A)(ii)(XIII) (sometimes 60601–5519. announcing the availability of
referred to as the ‘‘working disability’’ I am designating Mr. Benjamin R. Cohen as additional draft and revised draft
group) for at least 24 consecutive the presiding officer. If these arrangements product-specific guidances. The
VerDate Sep<11>2014 17:59 Jul 20, 2018 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\23JYN1.SGM 23JYN1](https://thefederalregister.org/doc/83_FR_34992/page/1.svg)
![Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 34853
TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when This notice is being published less than 15
days prior to the meeting due to the timing
CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current
thinking of FDA on, among other things, limitations imposed by the review and
UCTS—Continued funding cycle.
the product-specific design of BE
Beclomethasone dipropionate. studies to support ANDAs. They do not (Catalogue of Federal Domestic Assistance
Betamethasone dipropionate. Program Nos. 93.306, Comparative Medicine;
establish any rights for any person and 93.333, Clinical Research, 93.306, 93.333,
Betrixaban. are not binding on FDA or the public.
Ciprofloxacin. 93.337, 93.393–93.396, 93.837–93.844,
You can use an alternative approach if 93.846–93.878, 93.892, 93.893, National
Deferasirox.
Dexamethasone; Neomycin sulfate; Poly-
it satisfies the requirements of the Institutes of Health, HHS)
myxin b sulfate. applicable statutes and regulations. This Dated: July 17, 2018.
Epinephrine. guidance is not subject to Executive
Sylvia L. Neal,
Ethinyl estradiol; Norethindrone acetate. Order 12866.
Program Analyst, Office of Federal Advisory
Finafloxacin.
Fluocinolone acetonide.
IV. Electronic Access Committee Policy.
Loteprednol etabonate. [FR Doc. 2018–15605 Filed 7–20–18; 8:45 am]
Persons with access to the internet
Mecamylamine hydrochloride. BILLING CODE 4140–01–P
Methscopolamine bromide.
may obtain the draft guidances at either
Methylphenidate. https://www.fda.gov/Drugs/Guidance
Metyrosine. ComplianceRegulatoryInformation/ DEPARTMENT OF HEALTH AND
Moxifloxacin hydrochloride. Guidances/default.htm or https:// HUMAN SERVICES
Nebivolol hydrochloride; Valsartan. www.regulations.gov.
Nimodipine. Dated: July 18, 2018. National Institutes of Health
Nitisinone.
Omeprazole. Leslie Kux,
Center for Scientific Review; Notice of
Rifapentine. Associate Commissioner for Policy. Closed Meetings
Ritonavir. [FR Doc. 2018–15735 Filed 7–20–18; 8:45 am]
Sodium polystyrene sulfonate. BILLING CODE 4164–01–P Pursuant to section 10(d) of the
Triamcinolone acetonide. Federal Advisory Committee Act, as
Valbenazine tosylate. amended, notice is hereby given of the
DEPARTMENT OF HEALTH AND following meetings.
III. Drug Products for Which Revised HUMAN SERVICES The meetings will be closed to the
Draft Product-Specific Guidances are public in accordance with the
Available National Institutes of Health provisions set forth in sections
FDA is announcing the availability of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Center for Scientific Review; Notice of as amended. The grant applications and
revised draft product-specific guidances
Closed Meeting the discussions could disclose
for industry for drug products
containing the following active confidential trade secrets or commercial
Pursuant to section 10(d) of the property such as patentable material,
ingredients: Federal Advisory Committee Act, as and personal information concerning
amended, notice is hereby given of the individuals associated with the grant
TABLE 2—REVISED DRAFT PRODUCT- following meeting.
SPECIFIC GUIDANCES FOR DRUG applications, the disclosure of which
The meeting will be closed to the would constitute a clearly unwarranted
PRODUCTS public in accordance with the invasion of personal privacy.
provisions set forth in sections Name of Committee: Center for Scientific
Abiraterone acetate.
Dapagliflozin propanediol; Metformin hydro-
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Review Special Emphasis Panel; Urologic
chloride. as amended. The grant applications and and Urogynecologic Applications.
Diclofenac sodium. the discussions could disclose Date: July 20, 2018.
Donepezil hydrochloride; Memantine hydro- confidential trade secrets or commercial Time: 10:00 a.m. to 11:00 a.m.
chloride. property such as patentable material, Agenda: To review and evaluate grant
Esomeprazole strontium. and personal information concerning applications.
Ethosuximide. Place: National Institutes of Health, 6701
individuals associated with the grant Rockledge Drive, Bethesda, MD 20892
Glatiramer acetate. applications, the disclosure of which
Hydrocodone bitartrate. (Telephone Conference Call).
would constitute a clearly unwarranted Contact Person: Ganesan Ramesh, Ph.D.,
Lansoprazole.
Latanoprost.
invasion of personal privacy. Center for Scientific Review, National
Leucovorin calcium. Name of Committee: Center for Scientific Institutes of Health, 6701 Rockledge Drive,
Methylphenidate hydrochloride. Review Special Emphasis Panel; PAR–17– Room 2182, MSC 7818, Bethesda, MD 20892,
Morphine sulfate; Naltrexone hydrochloride. 031: Role of Age-Associated Metabolic 301–827–5467, ganesan.ramesh@nih.gov.
Nisoldipine. Changes in Alzhemimer’s Disease. This notice is being published less than 15
Oxycodone hydrochloride. Date: July 31, 2018. days prior to the meeting due to the timing
Ticagrelor. Time: 10:00 a.m. to 2:00 p.m. limitations imposed by the review and
Triamcinolone acetonide. Agenda: To review and evaluate grant funding cycle.
applications. Name of Committee: Center for Scientific
For a complete history of previously Place: National Institutes of Health, 6701 Review Special Emphasis Panel; PAR Panel:
amozie on DSK3GDR082PROD with NOTICES1
published Federal Register notices Rockledge Drive, Bethesda, MD 20892 Review of Aging Applications.
related to product-specific guidances, go (Virtual Meeting). Date: August 13, 2018.
Contact Person: Samuel C. Edwards, Ph.D., Time: 10:00 a.m. to 1:00 p.m.
to https://www.regulations.gov and
Chief, BDCN IRG, Center for Scientific Agenda: To review and evaluate grant
enter Docket No. FDA–2007–D–0369. Review, National Institutes of Health, 6701 applications.
These draft guidances are being Rockledge Drive, Room 5210, MSC 7846, Place: National Institutes of Health, 6701
issued consistent with FDA’s good Bethesda, MD 20892, (301) 435–1246, Rockledge Drive, Bethesda, MD 20892
guidance practices regulation (21 CFR edwardss@csr.nih.gov. (Virtual Meeting).
VerDate Sep<11>2014 17:59 Jul 20, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\23JYN1.SGM 23JYN1](https://thefederalregister.org/doc/83_FR_34992/page/3.svg)
Document Created: 2018-07-21 00:48:39
Document Modified: 2018-07-21 00:48:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 34851 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR