Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Drug Medicinal Product Designation, 27836-27838 [2017-12620]
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27836
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
ESTIMATED REALLOTMENT AMOUNTS OF FY 2016 LIHEAP FUNDS—Continued
Reallotment
amount
Grantee name
Quinault Indian Nation .................................................................................................................................................................
Sault Ste. Marie Tribe of Chippewa Indians ...............................................................................................................................
The Chickasaw Nation .................................................................................................................................................................
Three Affiliated Tribes of the Ft. Berthold Reservation ...............................................................................................................
Vermont .......................................................................................................................................................................................
4,091
4
195,952
348,035
657,888
Total ......................................................................................................................................................................................
3,253,866
Statutory Authority: 42 U.S.C. 8626.
at the end of August 18, 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.
Elizabeth Leo,
Grants Policy Specialist, Division of Grants
Policy, Office of Administration.
[FR Doc. 2017–12675 Filed 6–16–17; 8:45 am]
BILLING CODE 4184–80–P
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0015]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Orphan Drugs;
Common European Medicines Agency/
Food and Drug Administration
Application Form for Orphan Drug
Medicinal Product Designation
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
Common European Medicines Agency
(EMA)/FDA Application Form for
Orphan Drug Medicinal Product
Designation (Form FDA 3671).
DATES: Submit either electronic or
written comments on the collection of
information by August 18, 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 August 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:09 Jun 16, 2017
Jkt 241001
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.’’
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0015 for ‘‘Orphan Drugs;
Common EMA/FDA Application Form
for Orphan Medicinal Product
Designation (Form FDA 3671)—21 CFR
part 316.’’ 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://
E:\FR\FM\19JNN1.SGM
19JNN1
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov, 301–796–
8867.
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.
Orphan Drugs; Common EMA/FDA
Application Form for Orphan
Medicinal Product Designation (Form
FDA 3671) 21 CFR Part 316; OMB
Control Number 0910–0167—Extension
Sections 525 through 528 of the
Federal Food, Drug, and Cosmetic Act
VerDate Sep<11>2014
17:09 Jun 16, 2017
Jkt 241001
(the FD&C Act) (21 U.S.C. 360aa through
360dd) give FDA statutory authority to
do the following: (1) Provide
recommendations on investigations
required for approval of marketing
applications for orphan drugs, (2)
designate eligible drugs as orphan
drugs, (3) set forth conditions under
which a sponsor of an approved orphan
drug obtains exclusive approval, and (4)
encourage sponsors to make orphan
drugs available for treatment on an
‘‘open protocol’’ basis before the drug
has been approved for general
marketing. The implementing
regulations for these statutory
requirements have been codified under
part 316 (21 CFR part 316) and specify
procedures that sponsors of orphan
drugs use in availing themselves of the
incentives provided for orphan drugs in
the FD&C Act and sets forth procedures
FDA will use in administering the FD&C
Act with regard to orphan drugs.
Section 316.10 specifies the content
and format of a request for written
recommendations concerning the
nonclinical laboratory studies and
clinical investigations necessary for
approval of marketing applications.
Section 316.12 provides that, before
providing such recommendations, FDA
may require results of studies to be
submitted for review. Section 316.14
contains provisions permitting FDA to
refuse to provide written
recommendations under certain
circumstances. Within 90 days of any
refusal, a sponsor may submit
additional information specified by
FDA. Based on past experience, FDA
estimates that there will be one
respondent to §§ 316.10, 316.12, and
316.14 requiring 50 hours of human
resources annually.
Section 316.20 specifies the content
and format of an orphan drug
application which includes
requirements that an applicant
document that the disease is rare (affects
fewer than 200,000 persons in the
United States annually) or that the
sponsor of the drug has no reasonable
expectation of recovering costs of
research and development of the drug.
Section 316.21 specifies content of a
request for orphan drug designation
required for verification of orphan-drug
status. Section 316.26 allows an
applicant to amend the applications
under certain circumstances. Based on
past experience, FDA estimates 496
respondents to §§ 316.20, 316.21 and
316.26, requiring 93,000 hours of
human resources annually.
The Common EMA/FDA Application
Form for Orphan Medicinal Product
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27837
Designation (Form FDA 3671) is
intended to benefit sponsors who desire
to seek orphan designation of drugs
intended for rare diseases or conditions
from both the European Commission
and FDA by reducing the burden of
preparing separate applications to meet
the regulatory requirements in each
jurisdiction. It highlights the regulatory
cooperation between the United States
and the European Union mandated by
the Transatlantic Economic Council
(TEC). Based on past experience, FDA
estimates there will be 60 respondents
using the form requiring 450 hours of
human resources annually.
Section 316.22 specifies requirement
of a permanent resident agent for foreign
sponsors. Based on past experience,
FDA estimates 70 respondents requiring
140 hours of human resources annually.
Section 316.24(a) specifies a
requirement that sponsors respond to
deficiency letters from FDA on
designation requests within 1 year of
issuance of the deficiency letter, unless
within that time frame, the sponsor
requests an extension of time to
respond. Based on past experience, FDA
estimates 20 respondents requiring 40
hours of human resources annually.
Section 316.27 specifies content of a
change in ownership of orphan-drug
designation. Based on past experience,
FDA estimates 63 respondents requiring
315 hours of human resources annually.
Section 316.30 requires submission of
annual reports, including progress
reports on studies, a description of the
investigational plan, and a discussion of
changes that may affect orphan status.
Based on number of orphan-drug
designations, the number of respondents
is estimated as 744 requiring 2,232
hours of human resources annually.
Finally, § 316.36 describes information
required of sponsor when there is
insufficient quantity of approved
orphan drug. Based on past experience,
FDA estimates two respondents
requiring 90 hours of human resources
annually.
The information requested will
provide the basis for an FDA
determination that the drug is for a rare
disease or condition and satisfies the
requirements for obtaining orphan drug
status. Secondly, the information will
describe the medical and regulatory
history of the drug. The respondents to
this collection of information are
biotechnology firms, drug companies,
and academic clinical researchers.
FDA estimates the burden of this
collection of information as follows:
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27838
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Content and format when seeking written recommendations; results of studies; amendments (316.10, 316.12 &
316.14) .............................................................................
Content and format of a request for orphan-drug designation; request for verification of orphan-drug status;
amendments (316.20, 316.21 & 316.26) FDA Form
3671 ..................................................................................
Total ..............................................................................
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12620 Filed 6–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
[Docket No. FDA–2011–N–0076]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Records; Electronic Signatures
Total hours
1
1
50
50
496
60
70
1.25
1.5
1
620
90
70
150
5
2
93,000
450
140
20
1
20
2
40
63
744
1
1
63
744
5
3
315
2,232
2
3
6
15
90
........................
........................
........................
........................
96,317
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
VerDate Sep<11>2014
20:20 Jun 16, 2017
Jkt 241001
proposed collection of certain
information by the Agency. Under the
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
requirements governing the acceptance
of electronic records and electronic
signatures.
Submit either electronic or
written comments on the collection of
information by August 18, 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 August 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 18, 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.
DATES:
Electronic Submissions
HHS.
ACTION:
Hours per
response
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has experienced increases in: (1)
The number of submissions to change
ownership of orphan-drug designation
(21 CFR 316.27), (2) the number of
annual reports 21 CFR 316.30, and (3)
assurances of the availability of
sufficient quantities of the orphan drug
and the holder’s consent for the
approval of other marketing
applications for the same drug (21 CFR
316.36). In contrast, however, the use of
Form FDA 3671, the application form to
submit for product designation to the
European Medicines Agency and to the
FDA Office of Orphan Products, has
decreased from 6,760 to 450 total
burden hours.
AGENCY:
Total annual
responses
1
Notifications of changes in agents (316.22) ........................
Deficiency letters and granting orphan-drug designation
(316.24(a)) ........................................................................
Submissions to change ownership of orphan-drug designation (316.27) ..............................................................
Annual reports (316.30) .......................................................
Assurance of the availability of sufficient quantities of the
orphan drug; holder’s consent for the approval of other
marketing applications for the same drug (316.36) .........
1 There
Annual
frequency
per response
Number of
respondents
21 CFR section
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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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–0076 for ‘‘Electronic Records;
Electronic Signatures.’’ Received
E:\FR\FM\19JNN1.SGM
19JNN1
Agencies
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27836-27838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12620]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0015]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Orphan Drugs; Common European Medicines Agency/Food
and Drug Administration Application Form for Orphan Drug Medicinal
Product Designation
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 Common European Medicines
Agency (EMA)/FDA Application Form for Orphan Drug Medicinal Product
Designation (Form FDA 3671).
DATES: Submit either electronic or written comments on the collection
of information by August 18, 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 August 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 18, 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-0015 for ``Orphan Drugs; Common EMA/FDA Application Form for
Orphan Medicinal Product Designation (Form FDA 3671)--21 CFR part
316.'' 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://
[[Page 27837]]
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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov, 301-796-
8867.
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.
Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal
Product Designation (Form FDA 3671) 21 CFR Part 316; OMB Control Number
0910-0167--Extension
Sections 525 through 528 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360aa through 360dd) give FDA statutory
authority to do the following: (1) Provide recommendations on
investigations required for approval of marketing applications for
orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set
forth conditions under which a sponsor of an approved orphan drug
obtains exclusive approval, and (4) encourage sponsors to make orphan
drugs available for treatment on an ``open protocol'' basis before the
drug has been approved for general marketing. The implementing
regulations for these statutory requirements have been codified under
part 316 (21 CFR part 316) and specify procedures that sponsors of
orphan drugs use in availing themselves of the incentives provided for
orphan drugs in the FD&C Act and sets forth procedures FDA will use in
administering the FD&C Act with regard to orphan drugs.
Section 316.10 specifies the content and format of a request for
written recommendations concerning the nonclinical laboratory studies
and clinical investigations necessary for approval of marketing
applications. Section 316.12 provides that, before providing such
recommendations, FDA may require results of studies to be submitted for
review. Section 316.14 contains provisions permitting FDA to refuse to
provide written recommendations under certain circumstances. Within 90
days of any refusal, a sponsor may submit additional information
specified by FDA. Based on past experience, FDA estimates that there
will be one respondent to Sec. Sec. 316.10, 316.12, and 316.14
requiring 50 hours of human resources annually.
Section 316.20 specifies the content and format of an orphan drug
application which includes requirements that an applicant document that
the disease is rare (affects fewer than 200,000 persons in the United
States annually) or that the sponsor of the drug has no reasonable
expectation of recovering costs of research and development of the
drug. Section 316.21 specifies content of a request for orphan drug
designation required for verification of orphan-drug status. Section
316.26 allows an applicant to amend the applications under certain
circumstances. Based on past experience, FDA estimates 496 respondents
to Sec. Sec. 316.20, 316.21 and 316.26, requiring 93,000 hours of
human resources annually.
The Common EMA/FDA Application Form for Orphan Medicinal Product
Designation (Form FDA 3671) is intended to benefit sponsors who desire
to seek orphan designation of drugs intended for rare diseases or
conditions from both the European Commission and FDA by reducing the
burden of preparing separate applications to meet the regulatory
requirements in each jurisdiction. It highlights the regulatory
cooperation between the United States and the European Union mandated
by the Transatlantic Economic Council (TEC). Based on past experience,
FDA estimates there will be 60 respondents using the form requiring 450
hours of human resources annually.
Section 316.22 specifies requirement of a permanent resident agent
for foreign sponsors. Based on past experience, FDA estimates 70
respondents requiring 140 hours of human resources annually. Section
316.24(a) specifies a requirement that sponsors respond to deficiency
letters from FDA on designation requests within 1 year of issuance of
the deficiency letter, unless within that time frame, the sponsor
requests an extension of time to respond. Based on past experience, FDA
estimates 20 respondents requiring 40 hours of human resources
annually.
Section 316.27 specifies content of a change in ownership of
orphan-drug designation. Based on past experience, FDA estimates 63
respondents requiring 315 hours of human resources annually. Section
316.30 requires submission of annual reports, including progress
reports on studies, a description of the investigational plan, and a
discussion of changes that may affect orphan status. Based on number of
orphan-drug designations, the number of respondents is estimated as 744
requiring 2,232 hours of human resources annually. Finally, Sec.
316.36 describes information required of sponsor when there is
insufficient quantity of approved orphan drug. Based on past
experience, FDA estimates two respondents requiring 90 hours of human
resources annually.
The information requested will provide the basis for an FDA
determination that the drug is for a rare disease or condition and
satisfies the requirements for obtaining orphan drug status. Secondly,
the information will describe the medical and regulatory history of the
drug. The respondents to this collection of information are
biotechnology firms, drug companies, and academic clinical researchers.
FDA estimates the burden of this collection of information as
follows:
[[Page 27838]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Content and format when seeking 1 1 1 50 50
written recommendations;
results of studies; amendments
(316.10, 316.12 & 316.14)......
Content and format of a request 496 1.25 620 150 93,000
for orphan-drug designation; 60 1.5 90 5 450
request for verification of
orphan-drug status; amendments
(316.20, 316.21 & 316.26) FDA
Form 3671......................
Notifications of changes in 70 1 70 2 140
agents (316.22)................
Deficiency letters and granting 20 1 20 2 40
orphan-drug designation
(316.24(a))....................
Submissions to change ownership 63 1 63 5 315
of orphan-drug designation
(316.27).......................
Annual reports (316.30)......... 744 1 744 3 2,232
Assurance of the availability of 2 3 6 15 90
sufficient quantities of the
orphan drug; holder's consent
for the approval of other
marketing applications for the
same drug (316.36).............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 96,317
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA has experienced increases in: (1) The number of submissions to
change ownership of orphan-drug designation (21 CFR 316.27), (2) the
number of annual reports 21 CFR 316.30, and (3) assurances of the
availability of sufficient quantities of the orphan drug and the
holder's consent for the approval of other marketing applications for
the same drug (21 CFR 316.36). In contrast, however, the use of Form
FDA 3671, the application form to submit for product designation to the
European Medicines Agency and to the FDA Office of Orphan Products, has
decreased from 6,760 to 450 total burden hours.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12620 Filed 6-16-17; 8:45 am]
BILLING CODE 4164-01-P