Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics, 85973-85974 [2016-28732]

Download as PDF Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). 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. 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: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 85973 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. FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A– 12M, North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\29NON1.SGM 29NON1 85974 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 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 respondents Guidance on expedited programs Number of responses per respondent Average burden per response Total annual responses Total hours Priority Review Designation Request .................................. Breakthrough Therapy Designation Request ...................... 48 87 1.7 1.29 80 113 30 70 2,400 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 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration asabaliauskas on DSK3SPTVN1PROD with NOTICES [Docket No. FDA–2016–E–0622] Determination of Regulatory Review Period for Purposes of Patent Extension; NUWIQ AGENCY: Electronic Submissions Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for NUWIQ SUMMARY: VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 30, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 30, 2017. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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, E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85973-85974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28732]



[[Page 85973]]

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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, PRAStaff@fda.hhs.gov.

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