Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions, 44417-44420 [2017-20227]
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Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
accredits are ‘‘deemed’’ to meet the
CLIA requirements based on this
accreditation. Similarly, if a State
licensure program is determined to have
requirements that are equal to or more
stringent than those of CLIA, its
laboratories are considered to be exempt
from CLIA certification and
requirements. The information collected
will be used by HHS to: Determine
comparability/equivalency of the
accreditation organization standards
and policies or State licensure program
standards and policies to those of the
CLIA program; to ensure the continued
comparability/equivalency of the
standards; and to fulfill certain statutory
reporting requirements. Form No.:
CMS–R–185 (OMB control number:
0938–0686); Frequency: Occasionally;
Affected Public: Private Sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 12; Total Annual
Responses: 96; Total Annual Hours:
384. (For policy questions regarding this
collection contact Arlene Lopez at 410–
786–6782.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Business
Proposal Forms for Quality
Improvement Organizations (QIOs); Use:
The submission of proposal information
by current quality improvement
associations (QIOs) and other bidders,
on the appropriate forms, will satisfy
our need for meaningful, consistent, and
verifiable data with which to evaluate
contract proposals. We use the data
collected on the forms associated with
this information collection request to
negotiate QIO contracts. We will be able
to compare the costs reported by the
QIOs on the cost reports to the proposed
costs noted on the business proposal
forms. Subsequent contract and
modification negotiations will be based
on historic cost data. The business
proposal forms will be one element of
the historical cost data from which we
can analyze future proposed costs. In
addition, the business proposal format
will standardize the cost proposing and
pricing process among all QIOs. With
well-defined cost centers and line items,
proposals can be compared among QIOs
for reasonableness and appropriateness.
Form Number: CMS–718–721 (OMB
control number: 0938–0579); Frequency:
Annually; Affected Public: Business or
other for-profits and Not-for-profit
institutions; Number of Respondents:
20; Total Annual Responses: 20; Total
Annual Hours: 1,000. (For policy
questions regarding this collection
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contact Benjamin Bernstein at 410–786–
6570.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Fast Track
Appeals Notices: NOMNC/DENC; Use:
Providers shall deliver a Notice of
Medicare (Provider) Non-Coverage
(NOMNC) to beneficiaries, enrollees, or
both beneficiaries and enrollees no later
than two days prior to the end of
Medicare-covered services in skilled
nursing facilities, home health agencies,
comprehensive outpatient rehabilitation
facilities, and hospices. Beneficiaries,
enrollees or both beneficiaries and
enrollees will use this information to
determine whether they want to appeal
the service termination to their Quality
Improvement Organization (QIO). If the
beneficiaries, enrollees or both
beneficiaries decide to appeal, the
Medicare provider or health plan will
send the QIO and appellant a Detailed
Explanation of Non-Coverage (DENC)
detailing the rationale for the
termination decision. Form Number:
CMS–10123 and CMS–10124 (OMB
control number: 0938–0953); Frequency:
Occasionally; Affected Public: Private
sector—Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 28,177; Total Annual
Responses: 6,017,832; Total Annual
Hours: 1,111,196. (For policy questions
regarding this collection contact Janet
Miller at 404–562–1799.)
4. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Bid Pricing Tool
(BPT) for Medicare Advantage (MA)
Plans and Prescription Drug Plans
(PDP); Use: We require that Medicare
Advantage organizations and
Prescription Drug Plans complete the
BPT as part of the annual bidding
process. During this process,
organizations prepare their proposed
actuarial bid pricing for the upcoming
contract year and submit them to us for
review and approval. The purpose of the
BPT is to collect the actuarial pricing
information for each plan. The BPT
calculates the plan’s bid, enrollee
premiums, and payment rates. We
publish beneficiary premium
information using a variety of formats
(www.medicare.gov, the Medicare & You
handbook, Summary of Benefits
marketing information) for the purpose
of beneficiary education and
enrollment. Form Number: CMS–10142
(OMB control number: 0938–0944);
Frequency: Yearly; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 555; Total Annual
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44417
Responses: 4,995; Total Annual Hours:
149,850. (For policy questions regarding
this collection contact Rachel Shevland
at 410–786–3026.)
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Contract Year
2019 Plan Benefit Package (PBP)
Software and Formulary Submission;
Use: We require that Medicare
Advantage and Prescription Drug Plan
organizations submit a completed PBP
and formulary as part of the annual
bidding process. During this process,
organizations prepare their proposed
plan benefit packages for the upcoming
contract year and submit them to us for
review and approval. We publish
beneficiary education information using
a variety of formats. The specific
education initiatives that utilize PBP
and formulary data include web
application tools on www.medicare.gov
and the plan benefit insert in the
Medicare & You handbook. In addition,
organizations utilize the PBP data to
generate their Summary of Benefits
marketing information. Form Number:
CMS–R–262 (OMB control number
0938–0763); Frequency: Yearly; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 520; Total Annual
Responses: 5,675; Total Annual Hours:
54,550. (For policy questions regarding
this collection contact Kristy Holtje at
410–786–2209.)
Dated: September 19, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–20290 Filed 9–21–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0275]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Certification To
Accompany Drug, Biological Product,
and Device Applications or
Submissions
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
SUMMARY:
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Paperwork Reduction Act of 1995
(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 requirements for certain FDA
applications or submissions to be
accompanied by a certification, Form
FDA 3674, to ensure all applicable
statutory requirements have been met.
DATES: Submit either electronic or
written comments on the collection of
information by November 21, 2017.
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 November 21,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 21, 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.
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:
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• 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–
2011–N–0275 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions.’’ 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
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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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:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Certification To Accompany Drug,
Biological Product, and Device
Applications or Submissions (Form
FDA 3674)
OMB Control Number 0910–0616—
Extension
The information required under
section 402(j)(5)(B) of the Public Health
Service Act (PHS Act) (42 U.S.C.
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282(j)(5)(B)) is submitted in the form of
a certification, Form FDA 3674, which
accompanies applications and
submissions currently submitted to FDA
and already approved by OMB. The
OMB control numbers and expiration
dates for those applications and
submissions are: 21 CFR parts 312 and
314 (human drugs), OMB control
number 0910–0014, expiring February
28, 2019, and OMB control number
0910–0001, expiring December 31, 2017;
21 CFR parts 312 and 601 (biological
products), OMB control number 0910–
0014, expiring February 28, 2019, and
OMB control number 0910–0338,
expiring March 31, 2020; 21 CFR parts
807 and 814 (devices), OMB control
number 0910–0120, expiring June 30,
2020, and OMB control number 0910–
0231, expiring March 31, 2020.
Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110–85)
amended the PHS Act by adding section
402(j). The provisions broadened the
scope of clinical trials subject to
submitting information and required
additional information to be submitted
to the clinical trials databank (https://
clinicaltrials.gov/) (FDA has verified the
Web site address, but FDA is not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register)
previously established by the National
Institutes of Health (NIH)/National
Library of Medicine. This includes
expanded information on applicable
clinical trials and summary information
on the results of certain clinical trials.
The provisions include responsibilities
for FDA as well as several amendments
to the Federal Food, Drug, and Cosmetic
Act (the FD&C Act).
One provision, section 402(j)(5)(B) of
the PHS Act, requires that a certification
accompany human drug, biological, and
device product submissions made to
FDA. Specifically, at the time of
submission of an application under
sections 505, 515, or 520(m) of the
FD&C Act (21 U.S.C. 355, 360e, or
360j(m)), or under section 351 of the
PHS Act (42 U.S.C. 262), or submission
of a report under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)), such
application or submission must be
accompanied by a certification, Form
FDA 3674, that all applicable
requirements of section 402(j) of the
PHS Act have been met. Where
available, such certification must
include the appropriate National
Clinical Trial (NCT) numbers that are
assigned upon submission of required
information to the NIH databank at
https://clinicaltrials.gov/.
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The proposed extension of the
collection of information is necessary to
satisfy the previously mentioned
statutory requirement. The importance
of obtaining these data relates to
adherence to the legal requirements for
submissions to the clinical trials registry
and results data bank and ensuring that
individuals and organizations
submitting applications or reports to
FDA under the listed provisions of the
FD&C Act or the PHS Act adhere to the
appropriate legal and regulatory
requirements for certifying to having
complied with those requirements. The
failure to submit the certification
required by section 402(j)(5)(B) of the
PHS Act, and the knowing submission
of a false certification, are both
prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are
subject to civil money penalties. The
Form FDA 3674 provides a convenient
mechanism for sponsors/applicants/
submitters to satisfy the certification
requirements of the statutory provision.
To assist sponsors/applicants/
submitters in understanding the
statutory requirements associated with
Form FDA 3674, we have provided a
guidance available at: https://
www.fda.gov/RegulatoryInformation/
Guidances/ucm125335.htm. This
guidance recommends the applications
and submissions FDA considers should
be accompanied by the certification
form, Form FDA 3674. The applications
and submissions identified in the
guidance are reflected in the burden
analysis. In 2017, we updated the
guidance to include references to the
NIH Final Rule implementing 402(j) of
the PHS Act (42 U.S.C. 282(j)). The
Final Rule, published on September 21,
2016 (42 CFR part 11), clarifies the
requirements for submission of clinical
trial information to https://
clinicaltrials.gov/.
Investigational New Drug
Applications. FDA’s Center for Drug
Evaluation and Research (CDER)
received 1,669 investigational new drug
applications (INDs) and 15,285 clinical
protocol IND amendments in calendar
year (CY) 2016. CDER anticipates that
IND and clinical protocol amendment
submission rates will remain at or near
this level in the near future.
FDA’s Center for Biologics Evaluation
and Research (CBER) received 381 new
INDs and 456 clinical protocol IND
amendments in CY 2016. CBER
anticipates that IND and clinical
protocol amendment submission rates
will remain at or near this level in the
near future. The estimated total number
of submissions (new INDs and new
protocol submissions) subject to
mandatory certification requirements
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44419
under section 402(j)(5)(B) of the PHS
Act, is 16,954 for CDER plus 837 for
CBER, or 17,791 submissions per year.
The minutes per response is the
estimated number of minutes that a
respondent would spend preparing the
information to be submitted to FDA
under section 402(j)(5)(B) of the PHS
Act, including the time it takes to enter
the necessary information on the form.
Based on its experience with current
submissions, FDA estimates that
approximately 15 minutes on average
would be needed per response for
certifications that accompany IND
applications and clinical protocol
amendment submissions. It is assumed
that most submissions to investigational
applications will reference only a few
protocols for which the sponsor/
applicant/submitter has obtained a NCT
number from https://clinicaltrials.gov/
prior to making the submission to FDA.
It is also assumed that the sponsor/
applicant/submitter has electronic
capabilities allowing them to retrieve
the information necessary to complete
the form in an efficient manner.
Marketing Applications/Submissions.
In CY 2016, CDER and CBER received
252 new drug applications (NDA)/
biologics license applications (BLA)/
resubmissions and 1,067 NDA/BLA
amendments for which certifications are
needed. CDER and CBER received 253
efficacy supplements/resubmissions to
previously approved NDAs/BLAs in CY
2016. CDER and CBER anticipate that
new drug/biologic applications/
resubmissions and efficacy supplement
submission rates will remain at or near
this level in the near future.
FDA’s Center for Devices and
Radiological Health (CDRH) received a
total of 330 new applications for
premarket approvals (PMA), 510(k)
submissions containing clinical
information, PMA supplements,
applications for humanitarian device
exemptions (HDE) and amendments in
CY 2016. CDRH anticipates that
application, amendment, supplement,
and annual report submission rates will
remain at or near this level in the near
future.
FDA’s Office of Generic Drugs (OGD)
received 1,036 abbreviated new drug
applications (ANDAs) in 2016. OGD
received 698 bioequivalence
amendments/supplements in 2016. OGD
anticipates that application,
amendment, and supplement
submission rates will remain at or near
this level in the near future.
Based on its experience reviewing
NDAs, BLAs, PMAs, HDEs, 510(k)s, and
ANDAs and experience with current
submissions of Form FDA 3674, FDA
estimates that approximately 45 minutes
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on average would be needed per
response for certifications which
accompany NDA, BLA, PMA, HDE,
510(k), and ANDA marketing
applications and submissions. It is
assumed that the sponsor/applicant/
submitter has electronic capabilities
allowing them to retrieve the
information necessary to complete the
form in an efficient manner.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
(investigational
applications)
FDA center activity
Number of
respondents
(marketing
applications)
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
CDER
New Applications (IND) ................
Clinical Protocol Amendments
(IND).
New Marketing Applications/Resubmissions (NDA/BLA).
Clinical Amendments to Marketing
Applications.
Efficacy Supplements/Resubmissions.
1,669
15,285
........................
........................
1
1
1,669
15,285
0.25 (15 minutes) ..
0.25 (15 minutes) ..
417
3,821
............................
198
1
198
0.75 (45 minutes) ..
149
............................
1,067
1
1,067
0.75 (45 minutes) ..
800
............................
219
1
219
0.75 (45 minutes) ..
164
CBER
New Applications (IND) ................
Clinical Protocol Amendments
(IND).
New Marketing Applications/Resubmissions (NDA/BLA).
Clinical Amendments to Marketing
Applications.
Efficacy Supplements/Resubmissions (BLA only).
381
456
........................
........................
1
1
381
456
0.25 (15 minutes) ..
0.25 (15 minutes) ..
95
114
............................
54
1
54
0.75 (45 minutes) ..
41
............................
0
1
0
0.75 (45 minutes) ..
0
............................
34
1
34
0.75 (45 minutes) ..
26
1
330
0.75 (45 minutes) ..
247
CDRH
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to
contain clinical data).
............................
330
OGD
Original Applications .....................
Bioequivalence
Supplements/
Amendments.
............................
............................
1,036
698
1
1
........................
........................
0.75 (45 minutes) ..
0.75 (45 minutes) ..
777
524
Total ......................................
............................
........................
........................
........................
...............................
7,175
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–20227 Filed 9–21–17; 8:45 am]
[Docket No. FDA–2010–N–0622]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Color Additive
Certification Requests and
Recordkeeping
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
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Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by October 23,
2017.
DATES:
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: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0216. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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]]>Agencies
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44417-44420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20227]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0275]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Certification To Accompany Drug, Biological Product,
and Device Applications or Submissions
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
[[Page 44418]]
Paperwork Reduction Act of 1995 (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
requirements for certain FDA applications or submissions to be
accompanied by a certification, Form FDA 3674, to ensure all applicable
statutory requirements have been met.
DATES: Submit either electronic or written comments on the collection
of information by November 21, 2017.
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 November 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 21, 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.
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-2011-N-0275 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Certification to Accompany Drug,
Biological Product, and Device Applications or Submissions.'' 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 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.gpo.gov/fdsys/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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
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.
Certification To Accompany Drug, Biological Product, and Device
Applications or Submissions (Form FDA 3674)
OMB Control Number 0910-0616--Extension
The information required under section 402(j)(5)(B) of the Public
Health Service Act (PHS Act) (42 U.S.C.
[[Page 44419]]
282(j)(5)(B)) is submitted in the form of a certification, Form FDA
3674, which accompanies applications and submissions currently
submitted to FDA and already approved by OMB. The OMB control numbers
and expiration dates for those applications and submissions are: 21 CFR
parts 312 and 314 (human drugs), OMB control number 0910-0014, expiring
February 28, 2019, and OMB control number 0910-0001, expiring December
31, 2017; 21 CFR parts 312 and 601 (biological products), OMB control
number 0910-0014, expiring February 28, 2019, and OMB control number
0910-0338, expiring March 31, 2020; 21 CFR parts 807 and 814 (devices),
OMB control number 0910-0120, expiring June 30, 2020, and OMB control
number 0910-0231, expiring March 31, 2020.
Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding section
402(j). The provisions broadened the scope of clinical trials subject
to submitting information and required additional information to be
submitted to the clinical trials databank (https://clinicaltrials.gov/)
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register) previously established by the National Institutes
of Health (NIH)/National Library of Medicine. This includes expanded
information on applicable clinical trials and summary information on
the results of certain clinical trials. The provisions include
responsibilities for FDA as well as several amendments to the Federal
Food, Drug, and Cosmetic Act (the FD&C Act).
One provision, section 402(j)(5)(B) of the PHS Act, requires that a
certification accompany human drug, biological, and device product
submissions made to FDA. Specifically, at the time of submission of an
application under sections 505, 515, or 520(m) of the FD&C Act (21
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42
U.S.C. 262), or submission of a report under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)), such application or submission must be
accompanied by a certification, Form FDA 3674, that all applicable
requirements of section 402(j) of the PHS Act have been met. Where
available, such certification must include the appropriate National
Clinical Trial (NCT) numbers that are assigned upon submission of
required information to the NIH databank at https://clinicaltrials.gov/.
The proposed extension of the collection of information is
necessary to satisfy the previously mentioned statutory requirement.
The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results data bank and ensuring that individuals and organizations
submitting applications or reports to FDA under the listed provisions
of the FD&C Act or the PHS Act adhere to the appropriate legal and
regulatory requirements for certifying to having complied with those
requirements. The failure to submit the certification required by
section 402(j)(5)(B) of the PHS Act, and the knowing submission of a
false certification, are both prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are subject to civil money
penalties. The Form FDA 3674 provides a convenient mechanism for
sponsors/applicants/submitters to satisfy the certification
requirements of the statutory provision.
To assist sponsors/applicants/submitters in understanding the
statutory requirements associated with Form FDA 3674, we have provided
a guidance available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This guidance recommends the applications and
submissions FDA considers should be accompanied by the certification
form, Form FDA 3674. The applications and submissions identified in the
guidance are reflected in the burden analysis. In 2017, we updated the
guidance to include references to the NIH Final Rule implementing
402(j) of the PHS Act (42 U.S.C. 282(j)). The Final Rule, published on
September 21, 2016 (42 CFR part 11), clarifies the requirements for
submission of clinical trial information to https://clinicaltrials.gov/.
Investigational New Drug Applications. FDA's Center for Drug
Evaluation and Research (CDER) received 1,669 investigational new drug
applications (INDs) and 15,285 clinical protocol IND amendments in
calendar year (CY) 2016. CDER anticipates that IND and clinical
protocol amendment submission rates will remain at or near this level
in the near future.
FDA's Center for Biologics Evaluation and Research (CBER) received
381 new INDs and 456 clinical protocol IND amendments in CY 2016. CBER
anticipates that IND and clinical protocol amendment submission rates
will remain at or near this level in the near future. The estimated
total number of submissions (new INDs and new protocol submissions)
subject to mandatory certification requirements under section
402(j)(5)(B) of the PHS Act, is 16,954 for CDER plus 837 for CBER, or
17,791 submissions per year. The minutes per response is the estimated
number of minutes that a respondent would spend preparing the
information to be submitted to FDA under section 402(j)(5)(B) of the
PHS Act, including the time it takes to enter the necessary information
on the form.
Based on its experience with current submissions, FDA estimates
that approximately 15 minutes on average would be needed per response
for certifications that accompany IND applications and clinical
protocol amendment submissions. It is assumed that most submissions to
investigational applications will reference only a few protocols for
which the sponsor/applicant/submitter has obtained a NCT number from
https://clinicaltrials.gov/ prior to making the submission to FDA. It
is also assumed that the sponsor/applicant/submitter has electronic
capabilities allowing them to retrieve the information necessary to
complete the form in an efficient manner.
Marketing Applications/Submissions. In CY 2016, CDER and CBER
received 252 new drug applications (NDA)/biologics license applications
(BLA)/resubmissions and 1,067 NDA/BLA amendments for which
certifications are needed. CDER and CBER received 253 efficacy
supplements/resubmissions to previously approved NDAs/BLAs in CY 2016.
CDER and CBER anticipate that new drug/biologic applications/
resubmissions and efficacy supplement submission rates will remain at
or near this level in the near future.
FDA's Center for Devices and Radiological Health (CDRH) received a
total of 330 new applications for premarket approvals (PMA), 510(k)
submissions containing clinical information, PMA supplements,
applications for humanitarian device exemptions (HDE) and amendments in
CY 2016. CDRH anticipates that application, amendment, supplement, and
annual report submission rates will remain at or near this level in the
near future.
FDA's Office of Generic Drugs (OGD) received 1,036 abbreviated new
drug applications (ANDAs) in 2016. OGD received 698 bioequivalence
amendments/supplements in 2016. OGD anticipates that application,
amendment, and supplement submission rates will remain at or near this
level in the near future.
Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s,
and ANDAs and experience with current submissions of Form FDA 3674, FDA
estimates that approximately 45 minutes
[[Page 44420]]
on average would be needed per response for certifications which
accompany NDA, BLA, PMA, HDE, 510(k), and ANDA marketing applications
and submissions. It is assumed that the sponsor/applicant/submitter has
electronic capabilities allowing them to retrieve the information
necessary to complete the form in an efficient manner.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of
respondents respondents Number of Total annual
FDA center activity (investigational (marketing responses per responses Average burden per response Total hours
applications) applications) respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)............... 1,669 .............. 1 1,669 0.25 (15 minutes).............. 417
Clinical Protocol Amendments (IND)... 15,285 .............. 1 15,285 0.25 (15 minutes).............. 3,821
New Marketing Applications/ ................ 198 1 198 0.75 (45 minutes).............. 149
Resubmissions (NDA/BLA).
Clinical Amendments to Marketing ................ 1,067 1 1,067 0.75 (45 minutes).............. 800
Applications.
Efficacy Supplements/Resubmissions... ................ 219 1 219 0.75 (45 minutes).............. 164
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)............... 381 .............. 1 381 0.25 (15 minutes).............. 95
Clinical Protocol Amendments (IND)... 456 .............. 1 456 0.25 (15 minutes).............. 114
New Marketing Applications/ ................ 54 1 54 0.75 (45 minutes).............. 41
Resubmissions (NDA/BLA).
Clinical Amendments to Marketing ................ 0 1 0 0.75 (45 minutes).............. 0
Applications.
Efficacy Supplements/Resubmissions ................ 34 1 34 0.75 (45 minutes).............. 26
(BLA only).
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Marketing Applications (includes ................ 330 1 330 0.75 (45 minutes).............. 247
PMAs, HDEs, Supplements and 510(k)s
expected to contain clinical data).
--------------------------------------------------------------------------------------------------------------------------------------------------------
OGD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Original Applications................ ................ 1,036 1 .............. 0.75 (45 minutes).............. 777
Bioequivalence Supplements/Amendments ................ 698 1 .............. 0.75 (45 minutes).............. 524
------------------------------------------------------------------------------------------------------------------
Total............................ ................ .............. .............. .............. ............................... 7,175
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20227 Filed 9-21-17; 8:45 am]
BILLING CODE 4164-01-P
