81 FR 85973 - Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 229 (November 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 229 (November 29, 2016)
| Page Range | 85973-85974 | |
| FR Document | 2016-28732 |
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)] [Notices] [Pages 85973-85974] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28732] [[Page 85973]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0575] Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection found in FDA's ``Guidance for Industry: Expedited Programs for Serious Conditions--Drugs and Biologics.'' DATES: Submit either electronic or written comments on the collection of information by January 30, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-2013-D-0575 for ``Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 redacted/blacked out, will be available for public viewing and posted on http://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: http://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 http://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: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: Under 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 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 concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. [[Page 85974]] Guidance for Industry on Expedited Programs for Serious Conditions-- Drugs and Biologics OMB Control Number 0910-0765--Extension FDA has established four programs intended to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions: (1) Fast track designation including rolling review, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation. In support of these programs, the Agency has developed the guidance document, ``Guidance For Industry: Expedited Programs for Serious Conditions--Drugs and Biologics.'' The guidance outlines the programs' policies and procedures and describes applicable threshold criteria, including when to submit information to FDA. Respondents to the information collection are sponsors of drug and biological products appropriate for these expedited programs. Priority Review Designation Request. The guidance describes that a sponsor may expressly request priority review of an application. Based on information from FDA's databases and information available to FDA, we estimate that approximately 48 sponsors will prepare and submit approximately 1.7 priority review designation submissions that receive a priority review in accordance with the guidance and that the added burden for each submission will be approximately 30 hours to develop and submit to FDA as part of the application (totaling 2,400 hours). Breakthrough Therapy Designation Request. The guidance describes the process for sponsors to request breakthrough therapy designation in an application. Based on information from FDA's databases and information available to FDA, we estimate that approximately 87 sponsors will prepare approximately 1.29 breakthrough therapy designation submissions in accordance with the guidance and that the added burden for each submission will be approximately 70 hours to prepare and submit (totaling 7,910 hours). Accordingly, we estimate the burden of this information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Guidance on expedited programs Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Priority Review Designation 48 1.7 80 30 2,400 Request........................ Breakthrough Therapy Designation 87 1.29 113 70 7,910 Request........................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 10,310 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with the information collection. The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR parts 202.1, 314, and 601, and sections 505(a), 506(a)(1), 735, and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a), 356(a)(1), 379(g), and 379(h)) have been approved under OMB control numbers 0910-0686, 0910-0001, 0910-0338, 0910-0014, and 0910-0297. Dated: November 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28732 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85973
DEPARTMENT OF HEALTH AND written/paper submission and in the the information at: http://www.fda.gov/
HUMAN SERVICES manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Submissions’’ and ‘‘Instructions’’). default.htm.
Food and Drug Administration
Written/Paper Submissions Docket: For access to the docket to
[Docket No. FDA–2013–D–0575] read background documents or the
Submit written/paper submissions as
follows: electronic and written/paper comments
Agency Information Collection
Activities: Proposed Collection; • Mail/Hand delivery/Courier (for received, go to http://
written/paper submissions): Division of www.regulations.gov and insert the
Comment Request; Guidance for
Dockets Management (HFA–305), Food docket number, found in brackets in the
Industry on Expedited Programs for
Serious Conditions—Drugs and and Drug Administration, 5630 Fishers heading of this document, into the
Biologics Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
• For written/paper comments and/or go to the Division of Dockets
AGENCY: Food and Drug Administration, submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm.
HHS. Management, FDA will post your 1061, Rockville, MD 20852.
ACTION: Notice. comment, as well as any attachments,
except for information submitted, FOR FURTHER INFORMATION CONTACT: FDA
SUMMARY: The Food and Drug marked and identified, as confidential, PRA Staff, Office of Operations, Food
Administration (FDA) is announcing an if submitted as detailed in and Drug Administration, Three White
opportunity for public comment on the ‘‘Instructions.’’ Flint North, 11601 Landsdown St., 10A–
proposed collection of certain Instructions: All submissions received 12M, North Bethesda, MD 20852,
information by the Agency. Under the must include the Docket No. FDA– PRAStaff@fda.hhs.gov.
Paperwork Reduction Act of 1995 (the 2013–D–0575 for ‘‘Agency Information
PRA), Federal Agencies are required to Collection Activities: Proposed SUPPLEMENTARY INFORMATION: Under the
publish notice in the Federal Register Collection; Comment Request; Guidance PRA (44 U.S.C. 3501–3520), Federal
concerning each proposed collection of for Industry on Expedited Programs for Agencies must obtain approval from the
information, including each proposed Serious Conditions—Drugs and Office of Management and Budget
extension of an existing collection of Biologics.’’ Received comments will be (OMB) for each collection of
information, and to allow 60 days for placed in the docket and, except for information they conduct or sponsor.
public comment in response to the those submitted as ‘‘Confidential ‘‘Collection of information’’ is defined
notice. This notice solicits comments on Submissions,’’ publicly viewable at in 44 U.S.C. 3502(3) and 5 CFR
the information collection found in http://www.regulations.gov or at the 1320.3(c) and includes Agency requests
FDA’s ‘‘Guidance for Industry: Division of Dockets Management or requirements that members of the
Expedited Programs for Serious between 9 a.m. and 4 p.m., Monday public submit reports, keep records, or
Conditions—Drugs and Biologics.’’ through Friday. provide information to a third party.
DATES: Submit either electronic or • Confidential Submissions—To Section 3506(c)(2)(A) of the PRA (44
written comments on the collection of submit a comment with confidential U.S.C. 3506(c)(2)(A)) requires Federal
information by January 30, 2017. information that you do not wish to be Agencies to provide a 60-day notice in
ADDRESSES: You may submit comments made publicly available, submit your
the Federal Register concerning each
as follows: comments only as a written/paper
proposed collection of information,
submission. You should submit two
Electronic Submissions including each proposed extension of an
copies total. One copy will include the
information you claim to be confidential existing collection of information,
Submit electronic comments in the before submitting the collection to OMB
following way: with a heading or cover note that states
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS for approval. To comply with this
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The requirement, FDA is publishing notice
instructions for submitting comments. Agency will review this copy, including of the proposed collection of
Comments submitted electronically, the claimed confidential information, in information set forth in this document.
including attachments, to http:// its consideration of comments. The With respect to the following
www.regulations.gov will be posted to second copy, which will have the collection of information, FDA invites
the docket unchanged. Because your claimed confidential information comments on these topics: (1) Whether
comment will be made public, you are redacted/blacked out, will be available the proposed collection of information
solely responsible for ensuring that your for public viewing and posted on http:// is necessary for the proper performance
comment does not include any www.regulations.gov. Submit both of FDA’s functions, including whether
confidential information that you or a copies to the Division of Dockets the information will have practical
third party may not wish to be posted, Management. If you do not wish your utility; (2) the accuracy of FDA’s
such as medical information, your or name and contact information to be estimate of the burden of the proposed
anyone else’s Social Security number, or made publicly available, you can
collection of information, including the
confidential business information, such provide this information on the cover
validity of the methodology and
as a manufacturing process. Please note sheet and not in the body of your
assumptions used; (3) ways to enhance
that if you include your name, contact comments and you must identify this
asabaliauskas on DSK3SPTVN1PROD with NOTICES
information as ‘‘confidential.’’ Any the quality, utility, and clarity of the
information, or other information that
information marked as ‘‘confidential’’ information to be collected; and (4)
identifies you in the body of your
comments, that information will be will not be disclosed except in ways to minimize the burden of the
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other collection of information on
• If you want to submit a comment applicable disclosure law. For more respondents, including through the use
with confidential information that you information about FDA’s posting of of automated collection techniques,
do not wish to be made available to the comments to public dockets, see 80 FR when appropriate, and other forms of
public, submit the comment as a 56469, September 18, 2015, or access information technology.
VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/81_FR_86202/page/1.svg)
![85974 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
Guidance for Industry on Expedited programs’ policies and procedures and submit to FDA as part of the application
Programs for Serious Conditions— describes applicable threshold criteria, (totaling 2,400 hours).
Drugs and Biologics OMB Control including when to submit information Breakthrough Therapy Designation
Number 0910–0765—Extension to FDA. Respondents to the information Request. The guidance describes the
collection are sponsors of drug and process for sponsors to request
FDA has established four programs biological products appropriate for these
intended to facilitate and expedite breakthrough therapy designation in an
expedited programs.
development and review of new drugs application. Based on information from
Priority Review Designation Request.
to address unmet medical needs in the The guidance describes that a sponsor FDA’s databases and information
treatment of serious or life-threatening may expressly request priority review of available to FDA, we estimate that
conditions: (1) Fast track designation an application. Based on information approximately 87 sponsors will prepare
including rolling review, (2) from FDA’s databases and information approximately 1.29 breakthrough
breakthrough therapy designation, (3) available to FDA, we estimate that therapy designation submissions in
accelerated approval, and (4) priority approximately 48 sponsors will prepare accordance with the guidance and that
review designation. In support of these and submit approximately 1.7 priority the added burden for each submission
programs, the Agency has developed the review designation submissions that will be approximately 70 hours to
guidance document, ‘‘Guidance For receive a priority review in accordance prepare and submit (totaling 7,910
Industry: Expedited Programs for with the guidance and that the added hours).
Serious Conditions—Drugs and burden for each submission will be Accordingly, we estimate the burden
Biologics.’’ The guidance outlines the approximately 30 hours to develop and of this information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Guidance on expedited programs responses per burden per Total hours
respondents responses
respondent response
Priority Review Designation Request .................................. 48 1.7 80 30 2,400
Breakthrough Therapy Designation Request ...................... 87 1.29 113 70 7,910
Total .............................................................................. ........................ ........................ ........................ ........................ 10,310
1 There are no capital costs or operating and maintenance costs associated with the information collection.
The guidance also refers to previously and is publishing this notice of that the docket unchanged. Because your
approved collections of information determination as required by law. FDA comment will be made public, you are
found in FDA regulations. The has made the determination because of solely responsible for ensuring that your
collections of information in 21 CFR the submission of an application to the comment does not include any
parts 202.1, 314, and 601, and sections Director of the U.S. Patent and confidential information that you or a
505(a), 506(a)(1), 735, and 736 of the Trademark Office (USPTO), Department third party may not wish to be posted,
Federal Food, Drug, and Cosmetic Act of Commerce, for the extension of a such as medical information, your or
(21 U.S.C. 355(a), 356(a)(1), 379(g), and patent which claims that human anyone else’s Social Security number, or
379(h)) have been approved under OMB biological product. confidential business information, such
control numbers 0910–0686, 0910–0001, DATES: Anyone with knowledge that any as a manufacturing process. Please note
0910–0338, 0910–0014, and 0910–0297. of the dates as published (see the that if you include your name, contact
Dated: November 22, 2016. SUPPLEMENTARY INFORMATION section) are information, or other information that
incorrect may submit either electronic identifies you in the body of your
Leslie Kux,
or written comments and ask for a comments, that information will be
Associate Commissioner for Policy.
redetermination by January 30, 2017. posted on http://www.regulations.gov.
[FR Doc. 2016–28732 Filed 11–28–16; 8:45 am]
Furthermore, any interested person may • If you want to submit a comment
BILLING CODE 4164–01–P
petition FDA for a determination with confidential information that you
regarding whether the applicant for do not wish to be made available to the
extension acted with due diligence public, submit the comment as a
DEPARTMENT OF HEALTH AND written/paper submission and in the
HUMAN SERVICES during the regulatory review period by
May 30, 2017. See ‘‘Petitions’’ in the manner detailed (see ‘‘Written/Paper
SUPPLEMENTARY INFORMATION section for
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
more information. Written/Paper Submissions
[Docket No. FDA–2016–E–0622] ADDRESSES: You may submit comments Submit written/paper submissions as
as follows: follows:
Determination of Regulatory Review
Period for Purposes of Patent Electronic Submissions • Mail/Hand delivery/Courier (for
written/paper submissions): Division of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Extension; NUWIQ
Submit electronic comments in the Dockets Management (HFA–305), Food
AGENCY: Food and Drug Administration, following way: and Drug Administration, 5630 Fishers
HHS. • Federal eRulemaking Portal: http:// Lane, Rm. 1061, Rockville, MD 20852.
ACTION: Notice. www.regulations.gov. Follow the • For written/paper comments
instructions for submitting comments. submitted to the Division of Dockets
SUMMARY: The Food and Drug Comments submitted electronically, Management, FDA will post your
Administration (FDA) has determined including attachments, to http:// comment, as well as any attachments,
the regulatory review period for NUWIQ www.regulations.gov will be posted to except for information submitted,
VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/81_FR_86202/page/2.svg)
Document Created: 2016-11-29 00:32:53
Document Modified: 2016-11-29 00:32:53
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by January 30, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 85973 |
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