82 FR 13819 - Considerations in Demonstrating Interchangeability With a Reference Product; Draft Guidance for Industry; Availability; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 49 (March 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 49 (March 15, 2017)
| Page Range | 13819-13820 | |
| FR Document | 2017-05102 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13819-13820] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05102] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-0154] Considerations in Demonstrating Interchangeability With a Reference Product; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS.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 that appeared in the Federal Register of January 18, 2017. In the notice, FDA requested comments on ``Considerations in Demonstrating Interchangeability with a Reference Product.'' The Agency is taking this action in response to several requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice published January 18, 2017 (82 FR 5579). Submit either electronic or written comments by May 19, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 19, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 19, 2017. 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. 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2017-D-0154 for ``Considerations in Demonstrating Interchangeability With a Reference Product; Draft Guidance for Industry.'' Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 [[Page 13820]] redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042, or 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. SUPPLEMENTARY INFORMATION: In the Federal Register of January 18, 2017 (82 FR 5579), FDA published a notice with a 60-day comment period to request comments on ``Considerations in Demonstrating Interchangeability With a Reference Product.'' The Agency has received several requests for a 60-day extension of the comment period for the notice. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice. FDA has considered the requests and is extending the comment period for the notice for 60 days, until May 19, 2017. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-05102 Filed 3-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13819
assurance case. The assurance case meets FDA regulatory requirements, as manufacturers subject to FDA’s laws
requires the device sponsor to explicitly they relate to safety. and regulations.
describe how and why their device The respondents to this collection of FDA estimates the burden of this
information are infusion pump collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity burden per Total hours
respondents per responses response
respondent
Assurance Case Report ....................................................... 31 1 31 112 3,472
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of 31 respondents is Register of January 18, 2017. In the • If you want to submit a comment
based on the number of manufacturers notice, FDA requested comments on with confidential information that you
of infusion pumps listed in FDA’s ‘‘Considerations in Demonstrating do not wish to be made available to the
Registration and Listing database Interchangeability with a Reference public, submit the comment as a
(FURLS). The estimated average burden Product.’’ The Agency is taking this written/paper submission and in the
per response, 112 hours, is based on action in response to several requests for manner detailed (see ‘‘Written/Paper
FDA’s expectation of the amount of an extension to allow interested persons Submissions’’ and ‘‘Instructions’’).
information that will be contained in additional time to submit comments. Written/Paper Submissions
the report, on public comment received DATES: FDA is extending the comment
regarding the burden, on consultation Submit written/paper submissions as
period on the notice published January follows:
with stakeholders/industry, and on
FDA’s experience in the creation of an
18, 2017 (82 FR 5579). Submit either • Mail/Hand delivery/Courier (for
electronic or written comments by May written/paper submissions): Division of
assurance case argument structures for 19, 2017. Late, untimely filed comments
use in the guidance. Our estimate also Dockets Management (HFA–305), Food
will not be considered. Electronic and Drug Administration, 5630 Fishers
reflects that some information used to comments must be submitted on or
support the assurance case, such as Lane, Rm. 1061, Rockville, MD 20852.
before May 19, 2017. The https:// • For written/paper comments
activities conducted under existing www.regulations.gov electronic filing submitted to the Division of Dockets
design controls, is already covered in system will accept comments until Management, FDA will post your
another information collection request midnight Eastern Time at the end of comment, as well as any attachments,
(OMB control number 0910–0073) and May 19, 2017. Comments received by except for information submitted,
is therefore not included in the burden mail/hand delivery/courier (for written/ marked and identified, as confidential,
estimate in this information collection paper submissions) will be considered if submitted as detailed in
request. The respondents to this timely if they are postmarked or the ‘‘Instructions.’’
collection of information are infusion delivery service acceptance receipt is on Instructions: All submissions received
pump manufacturers. or before that date. must include the Docket No. FDA–
Dated: March 9, 2017. 2017–D–0154 for ‘‘Considerations in
ADDRESSES: You may submit comments
Leslie Kux, Demonstrating Interchangeability With a
as follows:
Associate Commissioner for Policy. Reference Product; Draft Guidance for
[FR Doc. 2017–05095 Filed 3–14–17; 8:45 am] Electronic Submissions Industry.’’ Received comments, those
BILLING CODE 4164–01–P
filed in a timely manner (see DATES),
Submit electronic comments in the will be placed in the docket and, except
following way: for those submitted as ‘‘Confidential
DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: Submissions,’’ publicly viewable at
HUMAN SERVICES https://www.regulations.gov. Follow the https://www.regulations.gov or at the
instructions for submitting comments. Division of Dockets Management
Food and Drug Administration Comments submitted electronically, between 9 a.m. and 4 p.m., Monday
including attachments, to https:// through Friday.
[Docket No. FDA–2017–D–0154] www.regulations.gov will be posted to • Confidential Submissions—To
the docket unchanged. Because your submit a comment with confidential
Considerations in Demonstrating
comment will be made public, you are information that you do not wish to be
Interchangeability With a Reference
solely responsible for ensuring that your made publicly available, submit your
Product; Draft Guidance for Industry;
comment does not include any comments only as a written/paper
Availability; Extension of Comment
confidential information that you or a submission. You should submit two
Period
third party may not wish to be posted, copies total. One copy will include the
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
AGENCY: Food and Drug Administration, such as medical information, your or information you claim to be confidential
HHS. anyone else’s Social Security number, or with a heading or cover note that states
ACTION:Notice of availability; extension confidential business information, such ‘‘THIS DOCUMENT CONTAINS
of comment period. as a manufacturing process. Please note CONFIDENTIAL INFORMATION.’’ The
that if you include your name, contact Agency will review this copy, including
SUMMARY: The Food and Drug information, or other information that the claimed confidential information, in
Administration (FDA or the Agency) is identifies you in the body of your its consideration of comments. The
extending the comment period for the comments, that information will be second copy, which will have the
notice that appeared in the Federal posted on https://www.regulations.gov. claimed confidential information
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![13820 Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
redacted/blacked out, will be available Dated: March 9, 2017. studies. The guidance describes
for public viewing and posted on Leslie Kux, procedures for sponsors to request
https://www.regulations.gov. Submit Associate Commissioner for Policy. special protocol assessment and for the
both copies to the Division of Dockets [FR Doc. 2017–05102 Filed 3–14–17; 8:45 am] Agency to act on such requests. The
Management. If you do not wish your BILLING CODE 4164–01–P
guidance provides information on how
name and contact information to be the Agency interprets and applies
made publicly available, you can provisions of the Food and Drug
provide this information on the cover DEPARTMENT OF HEALTH AND Administration Modernization Act of
sheet and not in the body of your HUMAN SERVICES 1997 and the specific Prescription Drug
comments and you must identify this User Fee Act of 1992 (PDUFA) goals for
information as ‘‘confidential.’’ Any Food and Drug Administration special protocol assessment associated
information marked as ‘‘confidential’’ with the development and review of
[Docket No. FDA–2016–N–3535]
will not be disclosed except in PDUFA products. The guidance
accordance with 21 CFR 10.20 and other Agency Information Collection describes the following two collections
applicable disclosure law. For more Activities; Submission for Office of of information: (1) The submission of a
information about FDA’s posting of Management and Budget Review; notice of intent to request special
comments to public dockets, see 80 FR Comment Request; Guidance for protocol assessment of a carcinogenicity
56469, September 18, 2015, or access Industry on Special Protocol protocol and (2) the submission of a
the information at: https://www.fda.gov/ Assessment request for special protocol assessment.
regulatoryinformation/dockets/ I. Notification for a Carcinogenicity
default.htm. AGENCY: Food and Drug Administration,
HHS. Protocol
Docket: For access to the docket to
ACTION: Notice. As described in the guidance, a
read background documents or the sponsor interested in Agency
electronic and written/paper comments SUMMARY: The Food and Drug assessment of a carcinogenicity protocol
received, go to https:// Administration (FDA, Agency, or we) is should notify the appropriate division
www.regulations.gov and insert the announcing that a proposed collection in FDA’s Center for Drug Evaluation and
docket number, found in brackets in the of information has been submitted to the Research (CDER) or the Center for
heading of this document, into the Office of Management and Budget Biologics Evaluation and Research
‘‘Search’’ box and follow the prompts (OMB) for review and clearance under (CBER) of an intent to request special
and/or go to the Division of Dockets the Paperwork Reduction Act of 1995 protocol assessment at least 30 days
Management, 5630 Fishers Lane, Rm. (the PRA). prior to submitting the request. With
1061, Rockville, MD 20852. DATES: Fax written comments on the such notification, the sponsor should
FOR FURTHER INFORMATION CONTACT: collection of information by April 14, submit relevant background information
Sandra Benton, Center for Drug 2017. so that the Agency may review reference
Evaluation and Research, Food and ADDRESSES: To ensure that comments on
material related to carcinogenicity
Drug Administration, 10903 New the information collection are received, protocol design prior to receiving the
Hampshire Ave., Bldg. 51, Rm. 6340, carcinogenicity protocol.
OMB recommends that written
Silver Spring, MD 20993–0002, 301– comments be faxed to the Office of II. Request for Special Protocol
796–1042, or Stephen Ripley, Center for Information and Regulatory Affairs, Assessment
Biologics Evaluation and Research, OMB, Attn: FDA Desk Officer, FAX:
Food and Drug Administration, 10903 The guidance asks that a request for
202–395–7285, or emailed to oira_ special protocol assessment be
New Hampshire Ave., Bldg. 71, Rm. submission@omb.eop.gov. All
7301, Silver Spring, MD 20993–0002, submitted as an amendment to the
comments should be identified with the investigational new drug application
240–402–7911. OMB control number 0910–0470. Also (IND) for the underlying product and
SUPPLEMENTARY INFORMATION: In the include the FDA docket number found that it be submitted to the Agency in
Federal Register of January 18, 2017 (82 in brackets in the heading of this triplicate with Form FDA 1571 attached.
FR 5579), FDA published a notice with document. The guidance also suggests that the
a 60-day comment period to request FOR FURTHER INFORMATION CONTACT: FDA sponsor submit the cover letter to a
comments on ‘‘Considerations in PRA Staff, Office of Operations, Food request for special protocol assessment
Demonstrating Interchangeability With a and Drug Administration, Three White via fax to the appropriate division in
Reference Product.’’ Flint North, 10A63, 11601 Landsdown CDER or CBER. Agency regulations (21
The Agency has received several St., North Bethesda, MD 20852, CFR 312.23(d)) state that information
requests for a 60-day extension of the PRAStaff@fda.hhs.gov. provided to the Agency as part of an
comment period for the notice. The SUPPLEMENTARY INFORMATION: In IND is to be submitted in triplicate and
requests conveyed concern that the compliance with 44 U.S.C. 3507, FDA with the appropriate cover form, Form
current 60-day comment period does has submitted the following proposed FDA 1571. An IND is submitted to FDA
not allow sufficient time to develop a collection of information to OMB for under existing regulations in part 312
meaningful or thoughtful response to review and clearance. (21 CFR part 312), which specifies the
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
the notice. information that manufacturers must
FDA has considered the requests and Guidance for Industry on Special submit so that FDA may properly
is extending the comment period for the Protocol Assessment OMB Control evaluate the safety and effectiveness of
notice for 60 days, until May 19, 2017. Number 0910–0470—Extension investigational drugs and biological
The Agency believes that a 60-day The ‘‘Guidance for Industry on products. The information collection
extension allows adequate time for Special Protocol Assessment’’ describes requirements resulting from the
interested persons to submit comments Agency procedures to evaluate issues preparation and submission of an IND
without significantly delaying related to the adequacy (e.g., design, under part 312 have been estimated by
rulemaking on these important issues. conduct, analysis) of certain proposed FDA and the reporting and
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Document Created: 2017-03-15 06:04:46
Document Modified: 2017-03-15 06:04:46
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period on the notice published January 18, 2017 (82 FR 5579). Submit either electronic or written comments by May 19, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 19, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 19, 2017. 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. | |
| Contact | Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042, or 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. | |
| FR Citation | 82 FR 13819 |
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