83 FR 13488 - Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 61 (March 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 61 (March 29, 2018)
| Page Range | 13488-13490 | |
| FR Document | 2018-06253 |
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)] [Notices] [Pages 13488-13490] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06253] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled ``Product- Specific Guidance for Doxycycline Hyclate.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for doxycycline hyclate oral delayed-release tablets. DATES: Submit either electronic or written comments on the draft guidance by May 29, 2018 to ensure that the Agency considers your comments on the draft guidance before it begins work on the final version of the guidance.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: [[Page 13489]]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 Guidance for Doxycycline Hyclate; Revised Draft Guidancefor Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' will be 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 guidance 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 document. FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), 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 ``Guidance for Industry on 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 to develop and disseminate product-specific guidances and to provide a meaningful opportunity for the public to consider and comment on the guidances. This notice announces the availability of a revised draft guidance for generic doxycycline hyclate oral delayed-release tablets. FDA initially approved new drug application (NDA) 050795 for DORYX (doxycycline hyclate oral delayed-release tablets) in May 2005. In May 2009, FDA issued a draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets and most recently revised that guidance in June 2015. On May 20, 2016, FDA approved a supplement to NDA 050795 for a new formulation of doxycycline hyclate delayed-release tablets in equivalent to (EQ) 60 milligram (mg) and EQ 120 mg strengths under the trade name Doryx MPC. We are now issuing another revised draft guidance for industry on doxycycline hyclate oral delayed-release tablets to include recommendations for demonstrating bioequivalence to these strengths. In November 2016, Mayne Pharma International Pty Ltd submitted a citizen petition requesting that FDA require certain in vitro dissolution criteria as part of the BE demonstration for any ANDA referencing DORYX MPC. FDA has reviewed the issues raised in this citizen petition and is responding to the citizen petition separately in the docket for that citizen petition (Docket No. FDA-2016-P-4047, available at https://www.regulations.gov). This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on the design of BE studies to support ANDAs for doxycycline hyclate oral delayed-release tablets. It does not establish any rights for any person and is 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. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. [[Page 13490]] Dated: March 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06253 Filed 3-28-18; 8:45 am] BILLING CODE 4164-01-P
![13488 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
burden estimates or any other aspect of CMS–10148 HIPAA Administrative appropriate direction of the complaint
this collection of information, including Simplification (Non-Privacy/Security) process and enables CMS to produce
the necessity and utility of the proposed Complaint Form accurate reports regarding complaint
information collection for the proper Under the PRA (44 U.S.C. 3501– activity.
performance of the agency’s functions, 3520), federal agencies must obtain The revision form associated with this
the accuracy of the estimated burden, approval from the Office of Management submission adds an option for filing
ways to enhance the quality, utility, and and Budget (OMB) for each collection of complaints under Unique Identifier and
clarity of the information to be information they conduct or sponsor. Operating Rules. It also requests an
collected, and the use of automated The term ‘‘collection of information’’ is email address for filed against entities,
collection techniques or other forms of defined in 44 U.S.C. 3502(3) and 5 CFR if available. Form Number: CMS–10148
information technology to minimize the 1320.3(c) and includes agency requests (OMB Control number: 0938–0948);
information collection burden. or requirements that members of the Frequency: Occasionally; Affected
public submit reports, keep records, or Public: Individuals; Number of
DATES:Comments must be received by
provide information to a third party. Respondents: 125; Total Annual
May 29, 2018.
Section 3506(c)(2)(A) of the PRA Responses: 125; Total Annual Hours:
ADDRESSES: When commenting, please requires federal agencies to publish a 125. (For policy questions regarding this
reference the document identifier or 60-day notice in the Federal Register collections contact Kevin Steward at
OMB control number. To be assured concerning each proposed collection of 410–786–6149.)
consideration, comments and information, including each proposed Dated: March 26, 2018.
recommendations must be submitted in extension or reinstatement of an existing William N. Parham, III,
any one of the following ways: collection of information, before Director, Paperwork Reduction Staff, Office
1. Electronically. You may send your submitting the collection to OMB for of Strategic Operations and Regulatory
comments electronically to http:// approval. To comply with this Affairs.
www.regulations.gov. Follow the requirement, CMS is publishing this [FR Doc. 2018–06312 Filed 3–28–18; 8:45 am]
instructions for ‘‘Comment or notice. BILLING CODE 4120–01–P
Submission’’ or ‘‘More Search Options’’
Information Collection
to find the information collection
document(s) that are accepting 1. Type of Information Collection DEPARTMENT OF HEALTH AND
comments. Request: Revision of the currently HUMAN SERVICES
2. By regular mail. You may mail approved collection.; Title of
Information Collection: HIPAA Food and Drug Administration
written comments to the following
address: CMS, Office of Strategic Administrative Simplification (Non- [Docket No. FDA–2007–D–0369]
Operations and Regulatory Affairs, Privacy/Security) Complaint Form; Use:
Division of Regulations Development, The authority for administering and Product-Specific Guidance for
Attention: Document Identifier/OMB enforcing compliance with the non- Doxycycline Hyclate; Revised Draft
Control Number ll, Room C4–26–05, privacy/security Health Insurance Guidance for Industry; Availability
7500 Security Boulevard, Baltimore, Portability and Accountability Act
(HIPAA) rules has been delegated to the AGENCY: Food and Drug Administration,
Maryland 21244–1850. HHS.
Centers for Medicare & Medicaid
To obtain copies of a supporting Services (CMS). At present, CMS’ ACTION: Notice of availability.
statement and any related forms for the compliance and enforcement activities
proposed collection(s) summarized in are primarily complaint-based. SUMMARY: The Food and Drug
this notice, you may make your request Although our enforcement efforts are Administration (FDA or Agency) is
using one of following: focused on investigating complaints, announcing the availability of a revised
1. Access CMS’ website address at they may also include conducting draft guidance for industry on generic
https://www.cms.gov/Regulations-and- compliance reviews to determine if a doxycycline hyclate oral delayed-release
Guidance/Legislation/Paperwork covered entity is in compliance. tablets, entitled ‘‘Product-Specific
ReductionActof1995/PRA-Listing.html. Potential violations can come through a Guidance for Doxycycline Hyclate.’’ The
complaint form or a compliance review. revised draft guidance, when finalized,
2. Email your request, including your will provide product-specific
address, phone number, OMB number, This standard form collects
identifying and contact information of recommendations on, among other
and CMS document identifier, to things, the design of bioequivalence
Paperwork@cms.hhs.gov. the complainant, as well as, the
identifying and contact information of (BE) studies to support abbreviated new
3. Call the Reports Clearance Office at the filed against entity (FAE). This drug applications (ANDAs) for
(410) 786–1326. information enables CMS to respond to doxycycline hyclate oral delayed-release
the complainant and gather more tablets.
FOR FURTHER INFORMATION CONTACT:
information if necessary, and to contact DATES: Submit either electronic or
William Parham at (410) 786–4669.
the FAE to discuss the complaint and written comments on the draft guidance
SUPPLEMENTARY INFORMATION: CMS’ findings. by May 29, 2018 to ensure that the
Contents In addition to the identifying and Agency considers your comments on the
contact information, the standard form draft guidance before it begins work on
sradovich on DSK3GMQ082PROD with NOTICES
This notice sets out a summary of the collects a summary which outlines the the final version of the guidance.
use and burden associated with the nature of the complaint. This summary ADDRESSES: You may submit comments
following information collections. More is used to determine the validity of the on any guidance at any time as follows:
detailed information can be found in complaint, and to categorize the
each collection’s supporting statement complaint as related to transactions, Electronic Submissions
and associated materials (see standards, code sets, unique identifiers, Submit electronic comments in the
ADDRESSES). and/or operating rules. This ensures the following way:
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![13490 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
Dated: March 20, 2018. electronic filing system will accept Safety and Risk Management Advisory
Leslie Kux, comments until midnight Eastern Time Committee; Notice of Meeting;
Associate Commissioner for Policy. at the end of May 21, 2018. Comments Establishment of a Public Docket;
[FR Doc. 2018–06253 Filed 3–28–18; 8:45 am] received by mail/hand delivery/courier Request for Comments.’’ Received
BILLING CODE 4164–01–P
(for written/paper submissions) will be comments, those filed in a timely
considered timely if they are manner (see the ADDRESSSES section),
postmarked or the delivery service will be placed in the docket and, except
DEPARTMENT OF HEALTH AND acceptance receipt is on or before that for those submitted as ‘‘Confidential
HUMAN SERVICES date. Submissions,’’ publicly viewable at
Comments received on or before May https://www.regulations.gov or at the
Food and Drug Administration 8, 2018, will be provided to the Dockets Management Staff between 9
[Docket No. FDA–2018–N–0875]
committees. Comments received after a.m. and 4 p.m., Monday through
that date will be taken into Friday.
Joint Meeting of the Anesthetic and consideration by FDA. Confidential Submissions—To submit
Analgesic Drug Products Advisory You may submit comments as a comment with confidential
Committee and the Drug Safety and follows: information that you do not wish to be
Risk Management Advisory Electronic Submissions made publicly available, submit your
Committee; Notice of Meeting; comments only as a written/paper
Submit electronic comments in the submission. You should submit two
Establishment of a Public Docket;
following way: copies total. One copy will include the
Request for Comments • Federal eRulemaking Portal: information you claim to be confidential
AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the with a heading or cover note that states
HHS. instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
ACTION: Notice; establishment of a Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ FDA
public docket; request for comments. including attachments, to https:// will review this copy, including the
www.regulations.gov will be posted to claimed confidential information, in its
SUMMARY: The Food and Drug the docket unchanged. Because your consideration of comments. The second
Administration (FDA) announces a comment will be made public, you are copy, which will have the claimed
forthcoming public advisory committee solely responsible for ensuring that your confidential information redacted/
meeting of the Anesthetic and Analgesic comment does not include any blacked out, will be available for public
Drug Products Advisory Committee and confidential information that you or a viewing and posted on https://
the Drug Safety and Risk Management third party may not wish to be posted, www.regulations.gov. Submit both
Advisory Committee. The general such as medical information, your or copies to the Dockets Management Staff.
function of the committees is to provide anyone else’s Social Security number, or If you do not wish your name and
advice and recommendations to FDA on confidential business information, such contact information be made publicly
regulatory issues. The meeting will be as a manufacturing process. Please note available, you can provide this
open to the public. FDA is establishing that if you include your name, contact information on the cover sheet and not
a docket for public comment on this information, or other information that in the body of your comments and you
document. identifies you in the body of your must identify the information as
DATES: The meeting will be held on May comments, that information will be ‘‘confidential.’’ Any information marked
22, 2018, from 8 a.m. to 4:30 p.m. posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed
• If you want to submit a comment
ADDRESSES: College Park Marriott Hotel except in accordance with 21 CFR 10.20
with confidential information that you
and Conference Center, General Vessey and other applicable disclosure law. For
do not wish to be made available to the
Ballroom, 3501 University Blvd., more information about FDA’s posting
public, submit the comment as a
Hyattsville, MD 20783. The conference of comments to public dockets, see 80
written/paper submission and in the
center’s telephone number is 301–985– FR 56469, September 18, 2015, or access
manner detailed (see ‘‘Written/Paper
7300. Answers to commonly asked the information at: https://www.gpo.gov/
Submissions’’ and ‘‘Instructions’’).
questions about FDA Advisory fdsys/pkg/FR-2015-09-18/pdf/2015-
Committee meetings may be accessed at: Written/Paper Submissions 23389.pdf.
https://www.fda.gov/Advisory Submit written/paper submissions as Docket: For access to the docket to
Committees/AboutAdvisoryCommittees/ follows: read background documents or the
ucm408555.htm. Information about the • Mail/Hand delivery/Courier (for electronic and written/paper comments
College Park Marriott Hotel and written/paper submissions): Dockets received, go to https://
Conference Center can be accessed at: Management Staff (HFA–305), Food and www.regulations.gov and insert the
https://www.marriott.com/hotels/travel/ Drug Administration, 5630 Fishers docket number, found in brackets in the
wasum-college-park-marriott-hotel-and- Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the
conference-center/. • For written/paper comments ‘‘Search’’ box and follow the prompts
FDA is establishing a docket for submitted to the Dockets Management and/or go to the Dockets Management
public comment on this meeting. The Staff, FDA will post your comment, as Staff, 5630 Fishers Lane, Rm. 1061,
docket number is FDA–2018–N–0875. well as any attachments, except for Rockville, MD 20852.
The docket will close on May 21, 2018. FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
information submitted, marked and
Submit either electronic or written identified, as confidential, if submitted Moon Hee V. Choi, Center for Drug
comments on this public meeting by as detailed in ‘‘Instructions.’’ Evaluation and Research, Food and
May 21, 2018. Please note that late, Instructions: All submissions received Drug Administration, 10903 New
untimely filed comments will not be must include the Docket No. FDA– Hampshire Ave., Bldg. 31, Rm. 2417,
considered. Electronic comments must 2018–N–0875 for ‘‘Joint Meeting of the Silver Spring, MD 20993–0002, 301–
be submitted on or before May 21, 2018. Anesthetic and Analgesic Drug Products 796–9001, Fax: 301–847–8533, email:
The https://www.regulations.gov Advisory Committee and the Drug AADPAC@fda.hhs.gov, or FDA
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Document Created: 2018-03-29 00:25:50
Document Modified: 2018-03-29 00:25:50
| 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 May 29, 2018 to ensure that the Agency considers your comments on the draft guidance before it begins work on the final version of the guidance. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850. | |
| FR Citation | 83 FR 13488 |
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