Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry; Availability; Extension of Comment Period, 8597-8598 [2020-03023]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Notices transparency) and resources to ensure customer experience is a focal point for agency leadership. To support this, OMB Circular A–11 Section 280 established government-wide standards for mature customer experience organizations in government and measurement. To enable Federal programs to deliver the experience taxpayers deserve, they must undertake three general categories of activities: Conduct ongoing customer research, gather and share customer feedback, and test services and digital products. These data collection efforts may be either qualitative or quantitative in nature or may consist of mixed methods. Additionally, data may be collected via a variety of means, including but not limited to electronic or social media, direct or indirect observation (i.e., in person, video and audio collections), interviews, questionnaires, surveys, and focus groups. The Centers for Medicare and Medicaid Services (CMS) will limit its inquiries to data collections that solicit strictly voluntary opinions or responses. Steps will be taken to ensure anonymity of respondents in each activity covered by this request. The results of the data collected will be used to improve the delivery of Federal services and programs. It will include the creation of personas, customer journey maps, and reports and summaries of customer feedback data and user insights. It will also provide government-wide data on customer experience that can be displayed on performance.gov to help build transparency and accountability of Federal programs to the customers they serve. CMS will collect this information by electronic means when possible, as well as by mail, fax, telephone, technical discussions, and in-person interviews. CMS may also utilize observational techniques to collect this information. Form Number: CMS–10710 (OMB control number: 0938-New); Frequency: Occasionally; Affected Public: Individuals or Households; Private Sector (business or other for-profits, notfor-profit institutions), State, Local or Tribal governments; Federal government; and Universities; Number of Respondents: 1,001,750; Number of Responses: Varied, dependent upon the data collection method used. The possible response time to complete a questionnaire or survey may be 3 minutes or up to 2 hours to participate in an interview; Total Annual Hours: 51,175. (For questions regarding this collection contact Aaron Lartey at 410– 786–7866). VerDate Sep<11>2014 16:56 Feb 13, 2020 Jkt 250001 Dated: February 11, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–03046 Filed 2–13–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–5585] Bridging for Drug-Device and BiologicDevice Combination Products; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability, extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 19, 2019. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ‘‘Bridging for Drug-Device and Biologic-Device Combination Products.’’ The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice of availability published December 19, 2019 (84 FR 69749). Submit either electronic or written comments by April 20, 2020. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 20, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 20, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 8597 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– 2019–D–5585 for ‘‘Bridging for DrugDevice and Biologic-Device Combination Products.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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 E:\FR\FM\14FEN1.SGM 14FEN1 8598 Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Notices 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.govinfo.gov/content/pkg/FR-201509-18/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. FOR FURTHER INFORMATION CONTACT: Robert Berlin, Center for Drug Evaluation and Research, Office of New Drugs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6373, Silver Spring, MD, 20993, 301–796–8828; Irene Chan, Center for Drug Evaluation and Research, Office of New Drugs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD, 20993, 301–796–3962; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, In the Federal Register of December 19, 2019, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry entitled ‘‘Bridging for DrugDevice and Biologic-Device Combination Products.’’ The Agency has received requests for an extension of the comment period for the notice of availability. Each request conveyed concern that the current 60day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice of availability. FDA has considered the requests and is extending the comment period for the notice of availability for 60 days, until April 20, 2020. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without compromising the timely publication of the final version of the guidance. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–5608] Wockhardt Limited, et al.; Withdrawal of Approval of 28 Abbreviated New Drug Applications AGENCY: ACTION: SUPPLEMENTARY INFORMATION: Dated: February 11, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–03023 Filed 2–13–20; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 28 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of March 16, 2020. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUMMARY: Application No. Drug Applicant ANDA 040732 .. Phenytoin Sodium Capsules, 100 milligrams (mg) (Extended) ANDA 065230 .. Ceftriaxone for Injection, Equivalent to (EQ) 250 mg base/ vial; EQ 500 mg base/vial; EQ 1 gram (g) base/vial; EQ 2 g base/vial. Ceftriaxone for Injection, EQ 1 g base/vial; EQ 2 g base/vial Piggy Back. Cefotaxime Sodium for Injection, EQ 500 mg base/vial; EQ 1 g base/vial; EQ 2 g base/vial. Cefotaxime Sodium for Injection, EQ 10 g base/vial Pharmacy Bulk Package. Cefotaxime Sodium for Injection, EQ 1 g base/vial; EQ 2 g base/vial. Cefoxitin for Injection, EQ 10 g base/vial Pharmacy Bulk Package. Cefoxitin for Injection, EQ 1 g base/vial; EQ 2 g base/vial ...... Cefepime Hydrochloride (HCl) for Injection, EQ 500 mg base/ vial; EQ 1 g base/vial; EQ 2 g base/vial. Cefuroxime Sodium for Injection, EQ 750 mg base/vial; EQ 1.5 g base/vial. Wockhardt Limited, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053. Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. ANDA 065231 .. ANDA 065290 .. ANDA 065292 .. khammond on DSKJM1Z7X2PROD with NOTICES MD 20993–0002, 240–402–7911; Andrew Yeatts, Center for Devices and Radiological Health, Food and Drug Administration 10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993–0002, 301–796–4539; or Patricia Love, Office of Special Medical Programs, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5144, Silver Spring, MD 20993–0002, 301–796–8933. ANDA 065293 .. ANDA 065312 .. ANDA 065313 .. ANDA 065369 .. ANDA 065483 .. VerDate Sep<11>2014 16:56 Feb 13, 2020 Jkt 250001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Do. Do. Do. Do. Do. Do. Do. Do. E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Notices]
[Pages 8597-8598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5585]


Bridging for Drug-Device and Biologic-Device Combination 
Products; Draft Guidance for Industry; Availability; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability, extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability that 
appeared in the Federal Register of December 19, 2019. In the notice of 
availability, FDA requested comments on the draft guidance for industry 
entitled ``Bridging for Drug-Device and Biologic-Device Combination 
Products.'' The Agency is taking this action in response to requests 
for an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the notice of 
availability published December 19, 2019 (84 FR 69749). Submit either 
electronic or written comments by April 20, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 20, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 20, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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-2019-D-5585 for ``Bridging for Drug-Device and Biologic-Device 
Combination Products.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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

[[Page 8598]]

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.govinfo.gov/content/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.

FOR FURTHER INFORMATION CONTACT: Robert Berlin, Center for Drug 
Evaluation and Research, Office of New Drugs, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6373, Silver 
Spring, MD, 20993, 301-796-8828; Irene Chan, Center for Drug Evaluation 
and Research, Office of New Drugs, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD, 20993, 301-
796-3962; Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911; Andrew Yeatts, Center 
for Devices and Radiological Health, Food and Drug Administration 10903 
New Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 
301-796-4539; or Patricia Love, Office of Special Medical Programs, 
Office of Combination Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5144, Silver Spring, MD 20993-0002, 301-
796-8933.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 19, 
2019, FDA published a notice of availability with a 60-day comment 
period to request comments on the draft guidance for industry entitled 
``Bridging for Drug-Device and Biologic-Device Combination Products.''
    The Agency has received requests for an extension of the comment 
period for the notice of availability. Each request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the notice of 
availability. FDA has considered the requests and is extending the 
comment period for the notice of availability for 60 days, until April 
20, 2020. The Agency believes that a 60-day extension allows adequate 
time for interested persons to submit comments without compromising the 
timely publication of the final version of the guidance.

    Dated: February 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03023 Filed 2-13-20; 8:45 am]
 BILLING CODE 4164-01-P
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