83 FR 7043 - Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7043-7046 | |
| FR Document | 2018-03236 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7043-7046] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03236] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0481] Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research; Availability AGENCY: Food and Drug Administration, HHS. [[Page 7044]] ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions'' along with the Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications (BIMO Technical Conformance Guide). The draft guidance and BIMO Technical Conformance Guide describe and provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA's Office of Regulatory Affairs (ORA) in the conduct of, bioresearch monitoring (BIMO) inspections. The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in new drug applications (NDAs) and biologics license applications (BLAs) regulated by CDER, as well as certain supplemental applications containing new clinical study reports. This draft guidance, when finalized, is intended to assist applicants in the submission of electronic data and information in standardized formats, and supersedes the previously issued draft guidance entitled ``Providing Submissions in Electronic Format--Summary Level Clinical Site Data for CDER's Inspection Planning'' (December 2012) (Summary Level Clinical Site Draft Guidance). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 17, 2018. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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-2018-D-0481 for ``Standardized Format for Electronic Submission of New Drug Application and Certain Biologics License Application Content for the Planning of Bioresearch Monitoring Inspections for Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications; Availability.'' 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 ``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. Submit written requests for single copies of this 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: Jean Mulinde, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0768. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of: (1) A draft guidance for industry entitled ``Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions'' and (2) the BIMO Technical Conformance Guide. This draft guidance and the BIMO Technical Conformance Guide describe and provide specifications for the electronic submission of data and information in standardized formats, for submitting information used by CDER in the planning of, and by ORA in the conduct [[Page 7045]] of, BIMO inspections. The draft guidance and the technical conformance guide address major (i.e., pivotal) studies used to support safety and efficacy claims in NDAs, BLAs, and NDA and BLA supplemental applications containing new clinical study reports that are regulated by CDER. To meet its review performance goals in accordance with CDER good review management principles and practices for products covered by the Prescription Drug User Fee Act, CDER generally initiates inspection planning early in the application review process (i.e., during the filing determination and review planning phase). CDER's inspection planning includes the selection of clinical investigator sites and other regulated entities for on-site inspections, and the preparation of assignment memos and background packages that CDER provides to FDA's ORA, which performs FDA's BIMO inspections. CDER uses the data and information described in this guidance to plan BIMO inspections, including: (1) To facilitate the timely identification of sites for inspection and (2) to ensure the availability of information needed to conduct BIMO inspections by ORA investigators. This draft guidance and the associated technical conformance guide supersede the previously issued Summary Level Clinical Site Draft Guidance that published in the Federal Register on December 19, 2012 (77 FR 75174). FDA carefully considered all of the comments received to the docket for the Summary Level Clinical Site Draft Guidance in developing this guidance. This draft guidance includes clarifications, additional detail on some topics, revised nomenclature for some data variables, and descriptions of additional data and information in standardized formats that are submitted in NDAs and BLAs to CDER, to facilitate the planning of routine BIMO inspections. In section 745A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-1(a)), Congress granted explicit authorization to FDA to specify, in guidance, the electronic format for submissions under section 505(b), (i), or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or (j)) and submissions under section 351(a) or (k) of the Public Health Service Act (42 U.S.C. 262(a) or (k)). Accordingly, to the extent that this guidance, when finalized, provides such requirements, as indicated by the use of the words must or required, this guidance will not be subject to the usual restrictions in FDA's good guidance practice (GGP) regulations, such as the requirement that guidances not establish legally enforceable responsibilities (see 21 CFR 10.115(d); see also the guidance for industry ``Providing Regulatory Submissions in Electronic Format--Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act,'' available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. To comply with GGP regulations and make sure that regulated entities and the public understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard language explaining that guidance documents should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. FDA is not including this standard language in this draft guidance document because it is not an accurate description of this guidance. Insofar as this guidance specifies the format for electronic submissions pursuant to section 745A(a) of the FD&C Act, when finalized, it will have binding effect. The draft guidance and the BIMO Technical Conformance Guide, when finalized, will represent the current thinking of FDA on standardized format for electronic submission of NDA and BLA content for the planning of BIMO inspections for CDER Submissions. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document. With respect to the collection of information associated with this draft guidance and the associated technical conformance guide, FDA invites comments on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. The draft guidance and the Bioresearch Monitoring Technical Conformance Guide provide the electronic format and specifications for submission of data and information used by CDER in the planning of, and by ORA in the conduct of, BIMO inspections. Data and information described in the draft guidance comprises information required in parts 312, 314, or 601 (21 CFR parts 312, 314, or 601), including case histories (Sec. 312.62(b)), information regarding foreign clinical studies not conducted under an investigational new drug application (IND) (Sec. 312.120), and the clinical data section (Sec. 314.50(d)(5)) and case report forms and tabulations (Sec. 314.50(f)), or in part 601 (Sec. 601.2 Applications for biologics licenses; procedures for filing) in an NDA, BLA, or supplement. The draft guidance and the associated technical conformance guide describe the electronic format of clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset that are submitted from all major (i.e., pivotal) studies used to support safety and efficacy claims in NDAs, BLAs, and NDA and BLA supplemental applications containing new clinical study reports. The variables described in the format are elements currently used in other submissions; some of the variable names described in the summary- level clinical site dataset are new. The financial disclosure information is currently reported in Module 1 (region specific information) of the electronic common technical document, but is new as a variable in the summary-level clinical site dataset. In addition, identifying that a study has been conducted under an IND is new as a request in a dataset. Initial preparation of some of the clinical study-level information, the subject-level data line listings by clinical site, and the summary-level clinical site dataset and the development of new standard operating procedures (SOPs) would require added time. Once SOPs have been established, generation of the clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset should not involve significant [[Page 7046]] additional work. The applicant would likely perform more quality assurance, which may add time to preparation and review of the submission. Based on CDER's data on the number of NDAs, BLAs, and NDA and BLA supplemental applications containing new clinical study reports that would be covered by the draft guidance, we estimate that each year approximately 75 applicants will submit for 125 original NDA or BLA applications and 152 supplemental applications containing new clinical study reports. We estimate that the submission of the clinical study- level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset for each application would take approximately 40 hours to prepare. Initial preparation of the clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset could involve the development of new SOPs for some applicants. We estimate that 75 applicants would take approximately 20 hours to develop and subsequently 2 hours annually to maintain and update the SOP(s). The clinical study-level information, subject-level data line listings by clinical site, and the summary-level clinical site dataset submitted with each application would likely involve additional quality assurance procedures, which would add approximately 2 hours for each submission. This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in part 312 have been approved under OMB control number 0910-0014; the collections of information in part 314 have been approved under OMB control number 0910-0001; the collections of information in part 601 have been approved under OMB control number 0910-0338. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of responses Activity respondents (i.e., per respondent Total Hours per Total hours applicants) (i.e., applications) responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- Submissions (clinical study-level information, subject-level 75 3.7 277 40 11,080 data line listings by clinical site, and the summary-level clinical site dataset)....................................... Quality Assurance............................................. 75 3.7 277 2 554 ----------------------------------------------------------------------------------------- Total..................................................... .................. .................... .............. .............. 11,634 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this information collection. Table 2--Estimated Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of records per Total records Hours per Total hours recordkeepers recordkeeper recordkeeper ---------------------------------------------------------------------------------------------------------------- Develop Initial SOP(s).......... 75 1 75 20 1,500 Maintain and Update SOP(s)...... 75 1 75 2 150 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,650 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this information collection. 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: February 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03236 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7043
claimed confidential information product and continues until FDA grants 3. The date the application was
redacted/blacked out, will be available permission to market the drug product. approved: September 16, 2014. FDA has
for public viewing and posted on Although only a portion of a regulatory verified the applicant’s claim that NDA
https://www.regulations.gov. Submit review period may count toward the 204760 was approved on September 16,
both copies to the Dockets Management actual amount of extension that the 2014.
Staff. If you do not wish your name and Director of USPTO may award (for This determination of the regulatory
contact information to be made publicly example, half the testing phase must be review period establishes the maximum
available, you can provide this subtracted as well as any time that may potential length of a patent extension.
information on the cover sheet and not have occurred before the patent was However, the USPTO applies several
in the body of your comments and you issued), FDA’s determination of the statutory limitations in its calculations
must identify this information as length of a regulatory review period for of the actual period for patent extension.
‘‘confidential.’’ Any information marked a human drug product will include all In its applications for patent extension,
as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase this applicant seeks 1,020 days or 272
except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). days of patent term extension.
CFR 10.20) and other applicable FDA has approved for marketing the III. Petitions
disclosure law. For more information human drug product MOVANTIK
about FDA’s posting of comments to (naloxegol oxalate). MOVANTIK is Anyone with knowledge that any of
public dockets, see 80 FR 56469, indicated for the treatment of opioid- the dates as published are incorrect may
September 18, 2015, or access the induced constipation in adult patients submit either electronic or written
information at: http://www.fda.gov/ with chronic non-cancer pain. comments and, under 21 CFR 60.24, ask
regulatoryinformation/dockets/ Subsequent to this approval, the USPTO for a redetermination (see DATES).
default.htm. received patent term restoration Furthermore, as specified in § 60.30 (21
Docket: For access to the docket to applications for MOVANTIK (U.S. CFR 60.30), any interested person may
read background documents or the Patent Nos. 7,662,365 and 7,786,133) petition FDA for a determination
electronic and written/paper comments from Nektar Therapeutics, and the regarding whether the applicant for
received, go to https:// USPTO requested FDA’s assistance in extension acted with due diligence
www.regulations.gov and insert the determining the patents’ eligibility for during the regulatory review period. To
docket number, found in brackets in the patent term restoration. In a letter dated meet its burden, the petition must
heading of this document, into the October 30, 2015, FDA advised the comply with all the requirements of
‘‘Search’’ box and follow the prompts USPTO that this human drug product § 60.30, including but not limited to:
and/or go to the Dockets Management had undergone a regulatory review Must be timely (see DATES), must be
Staff, 5630 Fishers Lane, Rm. 1061, period and that the approval of filed in accordance with § 10.20, must
Rockville, MD 20852. MOVANTIK represented the first contain sufficient facts to merit an FDA
FOR FURTHER INFORMATION CONTACT: permitted commercial marketing or use investigation, and must certify that a
Beverly Friedman, Office of Regulatory of the product. Thereafter, the USPTO true and complete copy of the petition
Policy, Food and Drug Administration, requested that FDA determine the has been served upon the patent
10903 New Hampshire Ave., Bldg. 51, product’s regulatory review period. applicant. (See H. Rept. 857, part 1, 98th
Rm. 6250, Silver Spring, MD 20993, Cong., 2d sess., pp. 41–42, 1984.)
II. Determination of Regulatory Review Petitions should be in the format
301–796–3600. Period
SUPPLEMENTARY INFORMATION:
specified in 21 CFR 10.30.
FDA has determined that the Submit petitions electronically to
I. Background applicable regulatory review period for https://www.regulations.gov at Docket
The Drug Price Competition and MOVANTIK is 2,493 days. Of this time, No. FDA–2013–S–0610. Submit written
Patent Term Restoration Act of 1984 2,127 days occurred during the testing petitions (two copies are required) to the
(Pub. L. 98–417) and the Generic phase of the regulatory review period, Dockets Management Staff (HFA–305),
Animal Drug and Patent Term while 366 days occurred during the Food and Drug Administration, 5630
Restoration Act (Pub. L. 100–670) approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD
generally provide that a patent may be were derived from the following dates: 20852.
extended for a period of up to 5 years 1. The date an exemption under Dated: February 13, 2018.
so long as the patented item (human section 505(i) of the Federal Food, Drug, Leslie Kux,
drug product, animal drug product, and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy.
medical device, food additive, or color U.S.C. 355(i)) became effective: [FR Doc. 2018–03245 Filed 2–15–18; 8:45 am]
additive) was subject to regulatory November 21, 2007. The applicant
BILLING CODE 4164–01–P
review by FDA before the item was claims October 22, 2007, as the date the
marketed. Under these acts, a product’s investigational new drug application
regulatory review period forms the basis (IND) became effective. However, FDA DEPARTMENT OF HEALTH AND
for determining the amount of extension records indicate that the IND effective HUMAN SERVICES
an applicant may receive. date was November 21, 2007, which was
A regulatory review period consists of 30 days after FDA receipt of the IND. Food and Drug Administration
two periods of time: A testing phase and 2. The date the application was
an approval phase. For human drug initially submitted with respect to the [Docket No. FDA–2018–D–0481]
daltland on DSKBBV9HB2PROD with NOTICES
products, the testing phase begins when human drug product under section Submission of Content Necessary for
the exemption to permit the clinical 505(b) of the FD&C Act: September 16, Bioresearch Monitoring Inspection
investigations of the drug becomes 2013. FDA has verified the applicant’s Planning for the Center of Drug
effective and runs until the approval claim that the new drug application Evaluation and Research; Availability
phase begins. The approval phase starts (NDA) for MOVANTIK (NDA 204760)
with the initial submission of an was initially submitted on September AGENCY: Food and Drug Administration,
application to market the human drug 16, 2013. HHS.
VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1](https://thefederalregister.org/doc/83_FR_7076/page/1.svg)
![7046 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
additional work. The applicant would dataset for each application would take assurance procedures, which would add
likely perform more quality assurance, approximately 40 hours to prepare. approximately 2 hours for each
which may add time to preparation and Initial preparation of the clinical study- submission.
review of the submission. level information, subject-level data line This draft guidance also refers to
Based on CDER’s data on the number listings by clinical site, and the previously approved collections of
of NDAs, BLAs, and NDA and BLA summary-level clinical site dataset information found in FDA regulations.
supplemental applications containing could involve the development of new The collections of information in part
new clinical study reports that would be SOPs for some applicants. We estimate
covered by the draft guidance, we 312 have been approved under OMB
that 75 applicants would take control number 0910–0014; the
estimate that each year approximately
approximately 20 hours to develop and collections of information in part 314
75 applicants will submit for 125
original NDA or BLA applications and subsequently 2 hours annually to have been approved under OMB control
152 supplemental applications maintain and update the SOP(s). The number 0910–0001; the collections of
containing new clinical study reports. clinical study-level information, subject- information in part 601 have been
We estimate that the submission of the level data line listings by clinical site, approved under OMB control number
clinical study-level information, subject- and the summary-level clinical site 0910–0338.
level data line listings by clinical site, dataset submitted with each application FDA estimates the burden of this
and the summary-level clinical site would likely involve additional quality collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of
Number of responses per Total Hours per
Activity respondents Total hours
respondent responses response
(i.e., applicants) (i.e., applications)
Submissions (clinical study-level information,
subject-level data line listings by clinical
site, and the summary-level clinical site
dataset) ......................................................... 75 3.7 277 40 11,080
Quality Assurance ............................................ 75 3.7 277 2 554
Total .......................................................... ................................ .................................... ........................ ........................ 11,634
1 There are no capital costs or operating and maintenance costs associated with this information collection.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Number of
Number of Total Hours per
Activity records per Total hours
recordkeepers records recordkeeper
recordkeeper
Develop Initial SOP(s) ......................................................... 75 1 75 20 1,500
Maintain and Update SOP(s) ............................................... 75 1 75 2 150
Total .............................................................................. ........................ ........................ ........................ ........................ 1,650
1 There are no capital costs or operating and maintenance costs associated with this information collection.
II. Electronic Access DEPARTMENT OF HEALTH AND withdrawn from sale for reasons of
HUMAN SERVICES safety or effectiveness. This
Persons with access to the internet determination will allow FDA to
may obtain the draft guidance at either Food and Drug Administration approve abbreviated new drug
https://www.fda.gov/Drugs/Guidance applications (ANDAs) for benazepril
[Docket No. FDA–2017–P–4852]
ComplianceRegulatoryInformation/ hydrochloride; hydrochlorothiazide oral
Guidances/default.htm or https:// Determination That LOTENSIN HCT tablets, 5 mg and 6.25 mg, if all other
www.regulations.gov. (Benazepril Hydrochloride; legal and regulatory requirements are
Dated: February 9, 2018. Hydrochlorothiazide) Oral Tablets, 5 met.
Leslie Kux, Milligrams and 6.25 Milligrams, Were FOR FURTHER INFORMATION CONTACT:
Not Withdrawn From Sale for Reasons Stacy Kane, Center for Drug Evaluation
Associate Commissioner for Policy.
of Safety or Effectiveness and Research, Food and Drug
[FR Doc. 2018–03236 Filed 2–15–18; 8:45 am]
AGENCY: Food and Drug Administration, Administration, 10903 New Hampshire
BILLING CODE 4164–01–P
HHS. Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
ACTION: Notice.
daltland on DSKBBV9HB2PROD with NOTICES
Stacy.Kane@fda.hhs.gov.
SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: In 1984,
Administration (FDA or Agency) has Congress enacted the Drug Price
determined that LOTENSIN HCT Competition and Patent Term
(benazepril hydrochloride; Restoration Act of 1984 (Pub. L. 98–417)
hydrochlorothiazide) oral tablets, 5 (the 1984 amendments), which
milligrams (mg) and 6.25 mg, were not authorized the approval of duplicate
VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1](https://thefederalregister.org/doc/83_FR_7076/page/4.svg)
Document Created: 2018-02-16 00:55:28
Document Modified: 2018-02-16 00:55:28
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 17, 2018. | |
| Contact | Jean Mulinde, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0768. | |
| FR Citation | 83 FR 7043 |
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