Biosimilar User Fee Rates for Fiscal Year 2015; Correction, 51178 [2014-20332]
Download as PDF
<![CDATA[
51178
Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices
weekly Enforcement Report, which
includes a description of the products
subject to the recall. The commenter can
check the Enforcement Report to view
drug products that have been recalled.
FDA does not include the name/license
number of the supervising pharmacist
because section 503B of the FD&C Act
does not require facilities to provide this
information to FDA when registering.
This information is not in SPL format
because FDA includes information in
this list that is not captured in SPL,
such as FDA regulatory actions.
(Issue 3) One commenter requested
insight on how FDA intends to
communicate with industry those
facilities that had previously registered
as human drug compounders before the
implementation of section 503B and
those that are now registering under
section 503B of the FD&C Act.
(Response) FDA has made available
on the Internet a list of the facilities that
have registered under section 503B of
the FD&C Act as outsourcing facilities.
FDA does not have a list of facilities that
had previously registered as human
drug compounders before section 503B
of the FD&C Act was enacted as there
was no category of registered human
drug compounder before this. Some
human drug compounding facilities
may have registered prior to the
enactment of section 503B as human
drug manufacturers under section 510 of
the FD&C Act (21 U.S.C. 360). A list of
all firms that are registered as
manufacturers under section 510 is
available to the public on FDA’s Drug
Establishments Current Registration
Site, which is separate from the list of
outsourcing facilities that have
registered under section 503B of the
FD&C Act.
(Issue 4) Another commenter noted
that FDA should define what would
constitute an undue burden justifying
the granting of a waiver from the
submission of registration information
electronically.
(Response) Section 503B(b)(3) of the
FD&C Act specifies the standard FDA is
to use to determine whether a waiver
should be granted. FDA may grant a
waiver if it finds that ‘‘use of electronic
means is not reasonable for the person
requesting the waiver.’’ FDA does not
anticipate many instances in which
electronic submission of registration
information will not be reasonable for
the person requesting the waiver,
because the information requested is
minimal, and the electronic system for
submitting the information is an
Internet-based system accessible to all
firms seeking to register. Because
human drug compounders are not
currently required to register and report
as outsourcing facilities, it is difficult to
anticipate the number of outsourcing
Number of
responses per
respondent
Number of
respondents
Compounding outsourcing facility
facilities that will participate in the
process.
As a result of comments received on
the ‘‘Draft Guidance for Industry on
Fees for Human Drug Compounding
Outsourcing Facilities Under the
Federal Food, Drug, and Cosmetic Act,’’
FDA has increased its estimates of the
number of outsourcing facilities that are
subject to each guidance. We now
estimate that 50 outsourcing facilities
will register and pay establishment fees,
and we have adjusted the other
estimates in the table (except for the
‘‘average burden per response’’)
accordingly.
We estimate that 50 outsourcing
facilities (‘‘number of respondents’’ and
‘‘total annual responses’’ in table 1, row
1) will annually submit to FDA
registration information using the SPL
format as specified in the guidance, and
that preparing and submitting this
information will take 4.5 hours per
registrant (‘‘average burden per
response’’ in table 1, row 1). We expect
to receive no more than one waiver
request from the electronic submission
process annually (‘‘number of
respondents’’ and ‘‘total annual
responses’’ in table 1, row 2), and that
each request should take 1 hour to
prepare and submit to us (‘‘average
burden per response’’ in table 1, row 2).
FDA estimates the burden of this
collection of information as follows:
Average
burden per
response
Total annual
responses
Total
hours
Electronic Submission of Registration Information Using
SPL Format ......................................................................
Waiver Request From Electronic Submission of Registration Information .................................................................
50
1
50
4.5
225
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
226
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
ACTION:
The Food and Drug
Administration is correcting a notice
entitled ‘‘Biosimilar User Fee Rates for
Fiscal Year 2015’’ that appeared in the
Federal Register of August 1, 2014 (79
FR 44795). The document announced
the rates for biosimilar user fees for
fiscal year 2015. The document was
published with the incorrect docket
number. This document corrects that
error.
BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0007]
Food and Drug Administration,
HHS
VerDate Mar<15>2010
17:44 Aug 26, 2014
Jkt 232001
Lisa
Granger, Office of Policy, Food and
Administration, 10990 New Hampshire
Ave., Bldg. 32, Rm. 3330, Silver Spring,
MD 20993–0002, 301–796–9115.
FOR FURTHER INFORMATION CONTACT:
Biosimilar User Fee Rates for Fiscal
Year 2015; Correction
PO 00000
Frm 00041
Fmt 4703
Sfmt 9990
In the
Federal Register of Friday, August 1,
2014, in FR Doc. 2014–18112, the
following correction is made:
1. On page 44795, in the third
column, in the Docket No. heading,
‘‘[Docket No. FDA–2013–N–0007]’’ is
corrected to read ‘‘[Docket No. FDA–
2014–N–0007]’’.
SUPPLEMENTARY INFORMATION:
SUMMARY:
[FR Doc. 2014–20276 Filed 8–26–14; 8:45 am]
AGENCY:
Notice; correction.
Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20332 Filed 8–26–14; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\27AUN1.SGM
27AUN1
]]>Agencies
[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Page 51178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0007]
Biosimilar User Fee Rates for Fiscal Year 2015; Correction
AGENCY: Food and Drug Administration, HHS
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Biosimilar User Fee Rates for Fiscal Year 2015'' that
appeared in the Federal Register of August 1, 2014 (79 FR 44795). The
document announced the rates for biosimilar user fees for fiscal year
2015. The document was published with the incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food
and Administration, 10990 New Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993-0002, 301-796-9115.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, August 1,
2014, in FR Doc. 2014-18112, the following correction is made:
1. On page 44795, in the third column, in the Docket No. heading,
``[Docket No. FDA-2013-N-0007]'' is corrected to read ``[Docket No.
FDA-2014-N-0007]''.
Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20332 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P
