82 FR 13816 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 82, Issue 49 (March 15, 2017)

Page Range		13816-13817
FR Document		2017-05104

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 82 Issue 49 (Wednesday, March 15, 2017)

[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13816-13817]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0575]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
14, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX:

[[Page 13817]]

202-395-7285, or emailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0765. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry (GFI) on Expedited Programs for Serious 
Conditions--Drugs and Biologics

OMB Control Number 0910-0765--Extension

    The 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, the Agency has developed the guidance 
document, ``GFI: 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).
    In the Federal Register of November 29, 2016 (81 FR 85973), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice.
    FDA estimates the burden of this collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Guidance on expedited programs      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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
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\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; 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: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05104 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P

13816 Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices

DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: FDA redirecting significant resources to
HUMAN SERVICES PRA Staff, Office of Operations, Food support these policies.
and Drug Administration, Three White FDA’s Center for Drug Evaluation and
Food and Drug Administration Flint North, 10A63, 11601 Landsdown Research, Office of the Commissioner,
[Docket No. FDA–2016–N–3586] St., North Bethesda, MD 20852, and any other Centers or Offices
PRAStaff@fda.hhs.gov. conducting focus groups about regulated
Agency Information Collection SUPPLEMENTARY INFORMATION: In drug products may need to conduct
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA focus groups on a variety of subjects
Management and Budget Review; has submitted the following proposed related to consumer, patient, or
Comment Request; Focus Groups collection of information to OMB for healthcare professional perceptions and
About Drug Products as Used by the review and clearance. use of drug products and related
Food and Drug Administration materials, including but not limited to,
Focus Groups About Drug Products as
AGENCY: Food and Drug Administration, Used by the Food and Drug direct-to-consumer prescription drug
HHS. Administration OMB Control Number promotion, physician labeling of
ACTION: Notice. 0910–0677—Extension prescription drugs, Medication Guides,
Focus groups provide an important over-the-counter drug labeling,
SUMMARY: The Food and Drug emerging risk communications, patient
Administration (FDA or we) is role in gathering information because
they allow for a more in-depth labeling, online sales of medical
announcing that a proposed collection products, and consumer and
of information has been submitted to the understanding of individuals’ attitudes,
beliefs, motivations, and feelings than professional education.
Office of Management and Budget
(OMB) for review and clearance under do quantitative studies. Focus groups Annually, FDA projects about 20
the Paperwork Reduction Act of 1995 serve the narrowly defined need for focus group studies using 160 focus
(the PRA). direct and informal opinion on a groups with an average of 9 persons per
specific topic and as a qualitative group, and lasting an average of 1.75
DATES: Fax written comments on the
collection of information by April 14, research tool have three major purposes: hours each. FDA is requesting this
• To obtain information that is useful burden for unplanned focus groups so
2017.
for developing variables and measures as not to restrict the agency’s ability to
ADDRESSES: To ensure that comments on for quantitative studies; gather information on public sentiment
the information collection are received, • to better understand people’s for its proposals in its regulatory and
OMB recommends that written attitudes and emotions in response to communications programs.
comments be faxed to the Office of topics and concepts;
In the Federal Register of November
Information and Regulatory Affairs, • and to further explore findings
OMB, Attn: FDA Desk Officer, FAX: 7, 2016 (81 FR 78161), we published a
obtained from quantitative studies.
202–395–7285, or emailed to oira_ FDA will use focus group findings to 60-day notice requesting public
submission@omb.eop.gov. All test and refine its ideas and to help comment on the proposed extension of
comments should be identified with the develop messages and other this collection of information. No
OMB control number 0910–0677. Also communications, but will generally comments were received in response to
include the FDA docket number found conduct further research before making the notice.
in brackets in the heading of this important decisions such as adopting FDA estimates the burden of this
document. new policies and allocating or collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Information collection activity responses per burden per Total hours
respondents responses
respondent response

Focus Groups About Drug Products ................................... 1,440 1 1,440 1.75 2,520
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 9, 2017. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Leslie Kux, HUMAN SERVICES Administration (FDA or we) is
Associate Commissioner for Policy. announcing that a proposed collection
Food and Drug Administration of information has been submitted to the
[FR Doc. 2017–05099 Filed 3–14–17; 8:45 am]
[Docket No. FDA–2013–D–0575] Office of Management and Budget
BILLING CODE 4164–01–P
(OMB) for review and clearance under
Agency Information Collection the Paperwork Reduction Act of 1995.
Activities; Submission for Office of
DATES: Fax written comments on the
asabaliauskas on DSK3SPTVN1PROD with NOTICES2

Management and Budget Review;
collection of information by April 14,
Comment Request; Guidance for
2017.
Industry on Expedited Programs for
Serious Conditions—Drugs and ADDRESSES: To ensure that comments on
Biologics the information collection are received,
AGENCY: Food and Drug Administration, OMB recommends that written
HHS. comments be faxed to the Office of
Information and Regulatory Affairs,
ACTION: Notice.
OMB, Attn: FDA Desk Officer, FAX:

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Document Created: 2017-03-15 06:04:32
Document Modified: 2017-03-15 06:04:32

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		Fax written comments on the collection of information by April 14, 2017.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		82 FR 13816

82 FR 13816 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 49 (March 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration