82 FR 41270 - Product-Specific Guidance for Digoxin; Draft Revised Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 167 (August 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 167 (August 30, 2017)
| Page Range | 41270-41271 | |
| FR Document | 2017-18386 |
[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)] [Notices] [Pages 41270-41271] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18386] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidance for Digoxin; Draft Revised Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft revised guidance for industry on generic digoxin tablets entitled ``Draft Guidance on Digoxin.'' The guidance, once finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for digoxin tablets. 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 revised guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft revised guidance by October 30, 2017. 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: [[Page 41271]] 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 ``Draft Guidance on Digoxin.'' 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 office 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 office, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft revised 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 revised 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 June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific guidances available to the public on FDA's Web site 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 draft revised product- specific guidance for generic digoxin tablets. FDA initially approved new drug application (NDA) 020405 for LANOXIN (digoxin tablets) in September 1997. In May 2008, we issued a final guidance for industry on generic digoxin tablets. We are now issuing a draft revised guidance for industry on generic digoxin tablets (``Draft Guidance on Digoxin''). In December 2015, Concordia Pharmaceuticals submitted a citizen petition requesting, among other things, that FDA amend the guidance for industry on BE recommendations for generic digoxin tablets issued in 2008. FDA has reviewed the issues raised in the citizen petition and is responding to the citizen petition (Docket No. FDA-2015-P-4566, available at https://www.regulations.gov). This draft revised guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft revised guidance, when finalized, will represent the current thinking of FDA on the design of BE studies to support ANDAs for digoxin 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. II. Electronic Access Persons with access to the internet may obtain the draft revised guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: August 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18386 Filed 8-29-17; 8:45 am] BILLING CODE 4164-01-P
![41270 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
healthcare career. The impact participants’ tenure and experience in follow-up survey for the HPOG 2.0
evaluation will assess the outcomes for HPOG programming, certifications and National Evaluation impact study. The
study participants that were offered educational achievements, job second follow-up survey is for
HPOG 2.0 training, financial assistance, placement, and benefits. These are the collecting data from both treatment and
and support services, compared to what key outcomes of interest for which data control group members at the 27 non-
their outcomes would have been if they are not otherwise available through tribal grantees, approximately 36
had not been offered HPOG 2.0 services. existing data sources. Previously months after baseline data collection
This Notice provides the opportunity approved collection activities under and random assignment. This
to comment on a proposed new 0970–0462 will continue under this new submission will also include data
information collection activity for the request for the National Evaluation of collection necessary for the National
HPOG 2.0 National Evaluation’s impact the non-tribal grantees. Evaluation’s cost benefit analysis.
study—the HPOG 2.0 Impact Evaluation In subsequent requests for clearance,
first follow-up survey. The first follow- we will submit (1) additional data Respondents: For the National
up survey of both treatment and control collection instruments to support the Evaluation impact study: HPOG 2.0
group members will be administered descriptive study of the 27 non-tribal study participants at the 27 non-tribal
approximately 15 months after baseline grantees participating in the HPOG 2.0 grantees.
data collection and random assignment. National Evaluation, including grantee Annual Response Burden Estimates:
The survey will collect data about key interview guides and participant (This information collection request is
outcomes of interest, including interview guides; and (2) the second for 3 years):
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response
HPOG 2.0 National Evaluation: 15-month Follow-up Sur-
vey .................................................................................... 10,400 3,467 1 1 3,467
In compliance with the requirement comments and suggestions submitted comments on the draft revised guidance
of section 3506(c)(2)(A) of the within 60 days of this publication. by October 30, 2017.
Paperwork Reduction Act of 1995, the Mary Jones, ADDRESSES: You may submit comments
Administration for Children and ACF/OPRE Reports Clearance Officer. as follows:
Families (ACF), Department of Health
[FR Doc. 2017–18410 Filed 8–29–17; 8:45 am] Electronic Submissions
and Human Services, is soliciting public
BILLING CODE 4184–72–P
comment on the specific aspects of the Submit electronic comments in the
information collection described above. following way:
Copies of the proposed collection of DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
information can be obtained and HUMAN SERVICES https://www.regulations.gov. Follow the
comments may be forwarded in writing instructions for submitting comments.
to the Administration for Children and Food and Drug Administration Comments submitted electronically,
Families, Office of Planning, Research [Docket No. FDA–2007–D–0369] including attachments, to https://
and Evaluation, 330 C Street SW., www.regulations.gov will be posted to
Washington, DC 20201, Attn: OPRE Product-Specific Guidance for Digoxin; the docket unchanged. Because your
Reports Clearance Officer. Email Draft Revised Guidance for Industry; comment will be made public, you are
address: OPREinfocollection@ Availability solely responsible for ensuring that your
acf.hhs.gov. All requests should be AGENCY: Food and Drug Administration, comment does not include any
identified by the title of the information HHS. confidential information that you or a
collection. third party may not wish to be posted,
ACTION: Notice of availability.
The Department specifically requests such as medical information, your or
SUMMARY: The Food and Drug anyone else’s Social Security number, or
comments on: (a) Whether the proposed
Administration (FDA, the Agency, or confidential business information, such
collection of information is necessary
we) is announcing the availability of a as a manufacturing process. Please note
for the proper performance of the
draft revised guidance for industry on that if you include your name, contact
functions of the agency, including information, or other information that
generic digoxin tablets entitled ‘‘Draft
whether the information shall have identifies you in the body of your
Guidance on Digoxin.’’ The guidance,
practical utility; (b) the accuracy of the comments, that information will be
once finalized, will provide product-
agency’s estimate of the burden of the posted on https://www.regulations.gov.
specific recommendations on, among
proposed collection of information; (c) other things, the design of • If you want to submit a comment
the quality, utility, and clarity of the bioequivalence (BE) studies to support with confidential information that you
information to be collected; and (d) abbreviated new drug applications do not wish to be made available to the
ways to minimize the burden of the (ANDAs) for digoxin tablets. public, submit the comment as a
mstockstill on DSK30JT082PROD with NOTICES
collection of information on DATES: Although you can comment on written/paper submission and in the
respondents, including through the use any guidance at any time (see 21 CFR manner detailed (see ‘‘Written/Paper
of automated collection techniques or 10.115(g)(5)), to ensure that the Agency Submissions’’ and ‘‘Instructions’’).
other forms of information technology. considers your comment on this draft
Consideration will be given to Written/Paper Submissions
revised guidance before it begins work
on the final version of the guidance, Submit written/paper submissions as
submit either electronic or written follows:
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![Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41271
• Mail/Hand delivery/Courier (for Staff office, 5630 Fishers Lane, Rm. This draft revised guidance is being
written/paper submissions): Dockets 1061, Rockville, MD 20852. issued consistent with FDA’s good
Management Staff (HFA–305), Food and Submit written requests for single guidance practices regulation (21 CFR
Drug Administration, 5630 Fishers copies of the draft revised guidance to 10.115). The draft revised guidance,
Lane, Rm. 1061, Rockville, MD 20852. the Division of Drug Information, Center when finalized, will represent the
• For written/paper comments for Drug Evaluation and Research, Food current thinking of FDA on the design
submitted to the Dockets Management and Drug Administration, 10001 New of BE studies to support ANDAs for
Staff, FDA will post your comment, as Hampshire Ave., Hillandale Building, digoxin tablets. It does not establish any
well as any attachments, except for 4th Floor, Silver Spring, MD 20993– rights for any person and is not binding
information submitted, marked and 0002. Send one self-addressed adhesive on FDA or the public. You can use an
identified, as confidential, if submitted label to assist that office in processing alternative approach if it satisfies the
as detailed in ‘‘Instructions.’’ your requests. See the SUPPLEMENTARY requirements of the applicable statutes
Instructions: All submissions received INFORMATION section for electronic and regulations.
must include the Docket No. FDA– access to the draft revised guidance II. Electronic Access
2007–D–0369 for ‘‘Draft Guidance on document.
Digoxin.’’ Received comments will be Persons with access to the internet
FOR FURTHER INFORMATION CONTACT: may obtain the draft revised guidance at
placed in the docket and, except for
Xiaoqiu Tang, Center for Drug either https://www.fda.gov/Drugs/
those submitted as ‘‘Confidential
Evaluation and Research, Food and GuidanceComplianceRegulatory
Submissions,’’ will be publicly viewable
Drug Administration, 10903 New Information/Guidances/default.htm or
at https://www.regulations.gov or at the
Hampshire Ave., Bldg. 75, Rm. 4730, https://www.regulations.gov.
Dockets Management Staff office
Silver Spring, MD 20993–0002, 301– Dated: August 24, 2017.
between 9 a.m. and 4 p.m., Monday
796–5850. Anna K. Abram,
through Friday.
• Confidential Submissions—To SUPPLEMENTARY INFORMATION: Deputy Commissioner for Policy, Planning,
submit a comment with confidential Legislation, and Analysis.
I. Background
information that you do not wish to be [FR Doc. 2017–18386 Filed 8–29–17; 8:45 am]
made publicly available, submit your In the Federal Register of June 11, BILLING CODE 4164–01–P
comments only as a written/paper 2010 (75 FR 33311), FDA announced the
submission. You should submit two availability of a guidance for industry
copies total. One copy will include the entitled ‘‘Bioequivalence DEPARTMENT OF HEALTH AND
information you claim to be confidential Recommendations for Specific HUMAN SERVICES
with a heading or cover note that states Products,’’ which explained the process
‘‘THIS DOCUMENT CONTAINS that would be used to make product- Food and Drug Administration
CONFIDENTIAL INFORMATION.’’ The specific guidances available to the [Docket No. FDA–2016–E–0624]
Agency will review this copy, including public on FDA’s Web site at https://
the claimed confidential information, in www.fda.gov/Drugs/ Determination of Regulatory Review
its consideration of comments. The GuidanceCompliance Period for Purposes of Patent
second copy, which will have the RegulatoryInformation/Guidances/ Extension; XTORO
claimed confidential information default.htm.
AGENCY: Food and Drug Administration,
redacted/blacked out, will be available As described in that guidance, FDA HHS.
for public viewing and posted on adopted this process to develop and
disseminate product-specific guidances ACTION: Notice.
https://www.regulations.gov. Submit
both copies to the Dockets Management and to provide a meaningful SUMMARY: The Food and Drug
Staff. If you do not wish your name and opportunity for the public to consider Administration (FDA or the Agency) has
contact information to be made publicly and comment on the guidances. This determined the regulatory review period
available, you can provide this notice announces the availability of a for XTORO and is publishing this notice
information on the cover sheet and not draft revised product-specific guidance of that determination as required by
in the body of your comments and you for generic digoxin tablets. law. FDA has made the determination
must identify this information as FDA initially approved new drug because of the submission of an
‘‘confidential.’’ Any information marked application (NDA) 020405 for LANOXIN application to the Director of the U.S.
as ‘‘confidential’’ will not be disclosed (digoxin tablets) in September 1997. In Patent and Trademark Office (USPTO),
except in accordance with 21 CFR 10.20 May 2008, we issued a final guidance Department of Commerce, for the
and other applicable disclosure law. For for industry on generic digoxin tablets. extension of a patent which claims that
more information about FDA’s posting We are now issuing a draft revised human drug product.
of comments to public dockets, see 80 guidance for industry on generic DATES: Anyone with knowledge that any
FR 56469, September 18, 2015, or access digoxin tablets (‘‘Draft Guidance on of the dates as published (in the
the information at: https://www.gpo.gov/ Digoxin’’). SUPPLEMENTARY INFORMATION section) are
fdsys/pkg/FR-2015-09-18/pdf/2015- In December 2015, Concordia incorrect may submit either electronic
23389.pdf. Pharmaceuticals submitted a citizen or written comments and ask for a
Docket: For access to the docket to petition requesting, among other things, redetermination by October 30, 2017.
read background documents or the that FDA amend the guidance for Furthermore, any interested person may
mstockstill on DSK30JT082PROD with NOTICES
electronic and written/paper comments industry on BE recommendations for petition FDA for a determination
received, go to https:// generic digoxin tablets issued in 2008. regarding whether the applicant for
www.regulations.gov and insert the FDA has reviewed the issues raised in extension acted with due diligence
docket number, found in brackets in the the citizen petition and is responding to during the regulatory review period by
heading of this document, into the the citizen petition (Docket No. FDA– February 26, 2018. See ‘‘Petitions’’ in
‘‘Search’’ box and follow the prompts 2015–P–4566, available at https:// the SUPPLEMENTARY INFORMATION section
and/or go to the Dockets Management www.regulations.gov). for more information.
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Document Created: 2017-08-30 04:08:25
Document Modified: 2017-08-30 04:08:25
| 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 revised guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft revised guidance by October 30, 2017. | |
| 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 | 82 FR 41270 |
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