83 FR 54113 - Product-Specific Guidance; Revised Draft Guidance for Industry on Sucralfate; Reopening of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 208 (October 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 208 (October 26, 2018)
| Page Range | 54113-54115 | |
| FR Document | 2018-23386 |
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)] [Notices] [Pages 54113-54115] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23386] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidance; Revised Draft Guidance for Industry on Sucralfate; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; reopening of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for a [[Page 54114]] revised draft product-specific guidance on Sucralfate that appeared in a notice of availability, published in the Federal Register of October 20, 2017. In that notice, FDA requested comments on the revised draft guidance for industry on Sucralfate, as well as comments on other product-specific guidances. FDA is reopening the comment period for the Draft Guidance on Sucralfate (revised October 2017) to facilitate submission of comments pertaining to this draft guidance following an FDA response to two citizen petitions. The petition response suggests that the petitioners submit to the docket comments relating to the guidance. DATES: Submit either electronic or written comments on the draft guidance by December 26, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 Guidance; Revised Draft Guidance for Industry on Sucralfate; Reopening of Comment Period.'' 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 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, 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 October 20, 2017 (82 FR 48826), FDA published a notice of availability with a 60-day comment period to request comments on the revised draft guidance for industry on Sucralfate, as well as comments on other product-specific guidances. This draft guidance includes recommendations pertaining to abbreviated new drug applications seeking approval of sucralfate oral suspension products, 1 gram/10 milliliters. The comment period for all draft guidances identified in that notice ended on December 19, 2017. On December 18, 2017, FDA received a citizen petition from Haynes and Boone, LLP (Docket No. FDA-2017-P-6922), requesting that FDA deny approval to any abbreviated new drug application for a sucralfate oral suspension drug product that relies on patient-based clinical endpoint studies to establish bioequivalence with the reference listed drug. On March 28, 2018, FDA received a citizen petition from Vertice Pharma (Docket No. FDA-2018-P-1310) requesting specific changes to the recommendations made in the ``Draft Guidance on Sucralfate'' (revised October 2017), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM573202.pdf. FDA denied both petitions in a joint response dated May 17, 2018. However, given the interest in this guidance, FDA is reopening the comment period until December 26, 2018. The Agency believes that an additional 60 days will allow adequate time for interested persons to submit comments without compromising the timely publication of the final version of the guidance. [[Page 54115]] 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. Dated: October 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23386 Filed 10-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices 54113
must identify this information as was issued), FDA’s determination of the This determination of the regulatory
‘‘confidential.’’ Any information marked length of a regulatory review period for review period establishes the maximum
as ‘‘confidential’’ will not be disclosed a human biological product will include potential length of a patent extension.
except in accordance with § 10.20 (21 all of the testing phase and approval However, the USPTO applies several
CFR 10.20) and other applicable phase as specified in 35 U.S.C. statutory limitations in its calculations
disclosure law. For more information 156(g)(1)(B). of the actual period for patent extension.
about FDA’s posting of comments to FDA has approved for marketing the In its applications for patent extension,
public dockets, see 80 FR 56469, human biologic product REBINYN this applicant seeks 1,660 days of patent
September 18, 2015, or access the (Coagulation Factor IX (Recombinant) term extension.
information at: https://www.gpo.gov/ GlycoPEGylated). REBINYN is indicated III. Petitions
fdsys/pkg/FR-2015-09-18/pdf/2015- for use in adults and children with
23389.pdf. hemophilia B for: (1) On-demand Anyone with knowledge that any of
Docket: For access to the docket to treatment and control of bleeding the dates as published are incorrect may
read background documents or the episodes, and (2) Perioperative submit either electronic or written
electronic and written/paper comments management of bleeding. Subsequent to comments and, under 21 CFR 60.24, ask
received, go to https:// this approval, the USPTO received a for a redetermination (see DATES).
www.regulations.gov and insert the patent term restoration application for Furthermore, as specified in § 60.30 (21
docket number, found in brackets in the REBINYN (U.S. Patent Nos. 7,138,371 CFR 60.30), any interested person may
heading of this document, into the and 7,179,617) from Novo Nordisk A/S, petition FDA for a determination
‘‘Search’’ box and follow the prompts and the USPTO requested FDA’s regarding whether the applicant for
and/or go to the Dockets Management assistance in determining this patent’s extension acted with due diligence
Staff, 5630 Fishers Lane, Rm. 1061, eligibility for patent term restoration. In during the regulatory review period. To
Rockville, MD 20852. a letter dated February 6, 2018, FDA meet its burden, the petition must
comply with all the requirements of
FOR FURTHER INFORMATION CONTACT: advised the USPTO that this human
§ 60.30, including but not limited to:
Beverly Friedman, Office of Regulatory biological product had undergone a
must be timely (see DATES), must be
Policy, Food and Drug Administration, regulatory review period and that the
filed in accordance with § 10.20, must
10903 New Hampshire Ave., Bldg. 51, approval of REBINYN represented the
contain sufficient facts to merit an FDA
Rm. 6250, Silver Spring, MD 20993, first permitted commercial marketing or
investigation, and must certify that a
301–796–3600. use of the product. Thereafter, the
true and complete copy of the petition
SUPPLEMENTARY INFORMATION: USPTO requested that FDA determine
has been served upon the patent
the product’s regulatory review period.
I. Background applicant. (See H. Rept. 857, part 1, 98th
II. Determination of Regulatory Review Cong., 2d sess., pp. 41–42, 1984.)
The Drug Price Competition and Period Petitions should be in the format
Patent Term Restoration Act of 1984 specified in 21 CFR 10.30.
(Pub. L. 98–417) and the Generic FDA has determined that the
Submit petitions electronically to
Animal Drug and Patent Term applicable regulatory review period for
https://www.regulations.gov at Docket
Restoration Act (Pub. L. 100–670) REBINYN is 2,793 days. Of this time,
No. FDA–2013–S–0610. Submit written
generally provide that a patent may be 2,412 days occurred during the testing
petitions (two copies are required) to the
extended for a period of up to 5 years phase of the regulatory review period,
Dockets Management Staff (HFA–305),
so long as the patented item (human while 381 days occurred during the
Food and Drug Administration, 5630
drug product, animal drug product, approval phase. These periods of time
Fishers Lane, Rm. 1061, Rockville, MD
medical device, food additive, or color were derived from the following dates:
20852.
additive) was subject to regulatory 1. The date an exemption under
section 505(i) of the Federal Food, Drug, Dated: October 22, 2018.
review by FDA before the item was
marketed. Under these acts, a product’s and Cosmetic Act (21 U.S.C. 355(i)) Leslie Kux,
regulatory review period forms the basis became effective: October 9, 2009. The Associate Commissioner for Policy.
for determining the amount of extension applicant claims May 16, 2009, as the [FR Doc. 2018–23437 Filed 10–25–18; 8:45 am]
an applicant may receive. date the investigational new drug BILLING CODE 4164–01–P
A regulatory review period consists of application (IND) became effective.
two periods of time: A testing phase and However, FDA records indicate that the
an approval phase. For human IND effective date was October 9, 2009, DEPARTMENT OF HEALTH AND
biological products, the testing phase which was the first date after receipt of HUMAN SERVICES
begins when the exemption to permit the IND that the investigational studies
were allowed to proceed. Food and Drug Administration
the clinical investigations of the
biological product becomes effective 2. The date the application was [Docket No. FDA–2007–D–0369]
and runs until the approval phase initially submitted with respect to the
begins. The approval phase starts with human biological product under section Product-Specific Guidance; Revised
the initial submission of an application 351 of the Public Health Service Act (42 Draft Guidance for Industry on
to market the human biological product U.S.C. 262): May 16, 2016. FDA has Sucralfate; Reopening of Comment
and continues until FDA grants verified the applicant’s claim that the Period
permission to market the biological biologics license application (BLA) for
khammond on DSK30JT082PROD with NOTICES
AGENCY: Food and Drug Administration,
product. Although only a portion of a REBINYN (BLA 125611/0) was initially HHS.
regulatory review period may count submitted on May 16, 2016. ACTION:Notice of availability; reopening
toward the actual amount of extension 3. The date the application was of comment period.
that the Director of USPTO may award approved: May 31, 2017. FDA has
(for example, half the testing phase must verified the applicant’s claim that BLA SUMMARY: The Food and Drug
be subtracted as well as any time that 125611/0 was approved on May 31, Administration (FDA or the Agency) is
may have occurred before the patent 2017. reopening the comment period for a
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![Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices 54115
II. Electronic Access DATES: Comments on the ICR must be OMB No.: 0990–0430—Office of the
Persons with access to the internet received on or before November 26, Assistant Secretary for Financial
may obtain the draft guidance at either 2018. Resources, Office of Grants and
https://www.fda.gov/Drugs/ ADDRESSES: Submit your comments to Acquisition Policy, and Accountability,
GuidanceCompliance OIRA_submission@omb.eop.gov or via Division of Acquisition.
RegulatoryInformation/Guidances/ facsimile to (202) 395–5806. Abstract: Crime Control Act—
default.htm or https:// FOR FURTHER INFORMATION CONTACT: Requirement for Background Checks:
www.regulations.gov. Sherrette Funn, Sherrette.Funn@hhs.gov Performance of HHS mission requires
Dated: October 22, 2018. or (202) 795–7714. When submitting the support of contractors. In some
Leslie Kux, comments or requesting information, circumstances, depending on the
Associate Commissioner for Policy. please include the document identifier requirements of the specific contract,
[FR Doc. 2018–23386 Filed 10–25–18; 8:45 am] 0990–New–30D and project title for the contractor is tasked to provide
BILLING CODE 4164–01–P reference. personnel who will be working with
SUPPLEMENTARY INFORMATION: Interested children under the age of 18. After
persons are invited to send comments contract award, contractor personnel
DEPARTMENT OF HEALTH AND regarding this burden estimate or any must undergo a criminal background
HUMAN SERVICES other aspect of this collection of check as required by HHS Acquisition
[Document Identifier: OS–0990–0430, 0431, information, including any of the Regulation (HHSAR) 337.103(d)(3) and
0432, 0433, 0434] following subjects: (1) The necessity and the clause at HHSAR 352.237–72 Crime
utility of the proposed information Control Act—Requirement for
Agency Information Collection collection for the proper performance of Background Checks before working on
Request; 30-Day Public Comment the agency’s functions; (2) the accuracy the contract as required by federal law
Request of the estimated burden; (3) ways to (Crime Control Act of 1990). The
AGENCY: Office of the Secretary, HHS. enhance the quality, utility, and clarity contractor is therefore required to
ACTION: Notice. of the information to be collected; and provide a list of the names of its
(4) the use of automated collection relevant personnel for purposes of
SUMMARY: In compliance with the techniques or other forms of information enabling HHS to conduct a criminal
requirement of the Paperwork technology to minimize the information background check.
Reduction Act of 1995, the Office of the collection burden.
Secretary (OS), Department of Health Title of the Collection: Crime Control The Agency is requesting a 3 year
and Human Services, is publishing the Act—Requirement for Background extension to collect this information
following summary of a proposed Checks. from public or private businesses.
collection for public comment. Type of Collection: Extension.
ESTIMATED ANNUALIZED BURDEN TABLE
Average
Number
Number of burden per Total burden
Type of respondent responses per
respondents response hours
respondent (in hours)
Business (contractor) ....................................................................................... 160 1 1 160
Total .......................................................................................................... 160 1 1 160
Title of the Collection: Acquisitions contractor that will need to use human Subjects), the provision at HHSAR
Involving Human Subjects. subjects, the Contracting Officer is 352.270–10 (Notice to Offerors—
Type of Collection: Extension. required to verify that, the contractor Protection of Human Subjects, Research
OMB No.: 0990–0431—Office of the holds a valid Federal Wide Assurance Involving Human Subjects Committee
Assistant Secretary for Financial (FWA) approved by the Office for (RIHSC) Approval of Research Protocols
Resources, Office of Grants and Human Research Protections (OHRP), as Required), and the clause at HHSAR
Acquisition Policy, and Accountability, described in HHSAR Subpart 370.3— 352.270–11 (Protection of Human
Division of Acquisition. Acquisitions Involving Human Subjects. Subjects—Research Involving Human
Abstract: Acquisitions Involving The provisions are implemented via Subjects Committee (RIHSC) Approval
Human Subjects: Performance of HHS contract clauses found at HHSAR of Research Protocols Required).
mission requires the support of 352.270–4a (Protection of Human The Agency is requesting a 3-year
contractors involving human subjects. Subjects), the clause at HHSAR extension to collect this information
Before awarding a contract to any 352.270–4b (Protection of Human from public or private businesses.
ESTIMATED ANNUALIZED BURDEN TABLE
khammond on DSK30JT082PROD with NOTICES
Average
Number
Number of burden per Total burden
Type of respondent responses per
respondents response hours
respondent (in hours)
Business (contractor) ....................................................................................... 90 4 5 1,800
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Document Created: 2018-10-26 02:27:48
Document Modified: 2018-10-26 02:27:48
| 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; reopening of comment period. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 26, 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 54113 |
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