Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 4931-4932 [2015-01669]
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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Contact lens cleaning solution labeling—800.10(a)(3) and
800.12(c) ........................................................................
Liquid ophthalmic preparation labeling—800.10(b)(2) .......
Manufacturer, packer, or distributor information—801.1 ...
Adequate directions for use—801.5 ..................................
Statement of identity—801.61 ...........................................
Declaration of net quantity of contents—801.62 ...............
Prescription device labeling—801.109 ..............................
Retail exemption for prescription devices—801.110 .........
Processing, labeling, or repacking; non-sterile devices—
801.150(e) ......................................................................
Labeling of articles intended for lay use in the repairing
and/or refitting of dentures—801.405(b)(1) ....................
Dentures; information regarding temporary and emergency use—801.405(c) ..................................................
Labeling requirements for hearing aids—801.420(c)(1) ....
Technical data for hearing aids—801.420(c)(4) ................
Hearing aids, opportunity to review user instructional brochure—801.421(b) ..........................................................
Hearing aids, availability of user instructional brochure—
801.421(c) ......................................................................
User labeling for menstrual tampons—801.430(d) ............
Menstrual
tampons,
ranges
of
absorbency—
801.430(e)(2) ..................................................................
User labeling for latex condoms—801.435(b), (c), and (h)
Labeling for IVDs—809.10(a) and (b) ...............................
Labeling for general purpose laboratory reagents—
809.10(d)(1) ....................................................................
Labeling for analyte specific reagents—809.10(e) ............
Labeling for OTC test sample collection systems for
drugs of abuse testing—809.10(f) ..................................
Advertising and promotional materials for ASRs—
809.30(d) ........................................................................
Labeling of sunlamp products—1040.20(d) .......................
Total ............................................................................
1 There
[FR Doc. 2015–01668 Filed 1–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0509]
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Appeals of
Science-Based Decisions Above the
Division Level at the Center for
Veterinary Medicine
Food and Drug Administration,
HHS.
ACTION:
Total annual
disclosures
Average
burden per
disclosure
Total hours
17
17
13,780
6,657
6,657
6,657
7,558
30,000
8
8
7
6
6
6
6
667
136
136
96,460
39,942
39,942
39,942
45,348
20,010,000
1
1
1
22.35
1
1
17.77
0.25
136
136
96,460
892,704
39,942
39,942
805,834
5,002,500
377
34
12,818
4
51,272
31
1
31
4
124
31
86
86
1
12
12
31
1,032
1,032
4
40
80
124
41,280
82,560
10,000
160
1,600,000
0.30
480,000
10,000
22
5
8
50,000
176
0.17
2
8,500
352
22
63
1,700
8
6
6
176
378
10,200
2
100
80
352
37,800
816,000
300
300
2
25
600
7,500
40
1
24,000
7,500
20
1
20
100
2,000
300
30
25
1
7,500
30
1
10
7,500
300
........................
..........................
........................
........................
8,437,318
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
disclosures per
respondent
Number of
respondents
Activity/21 CFR section
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
VerDate Sep<11>2014
20:09 Jan 28, 2015
Jkt 235001
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 March 2,
2015.
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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0566. 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002 PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
has submitted the following proposed
collection of information to OMB for
review and clearance.
Appeals of Science-Based Decisions
Above the Division Level at CVM—21
CFR 10.75 (OMB Control Number 0910–
0566—Revision)
Respondents: Respondents to this
collection of information are applicants
that wish to submit a request for review
of a scientific dispute.
The Center for Veterinary Medicine’s
(CVM’s) guidance for industry #79
entitled ‘‘Dispute Resolution Procedures
for Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine,’’ describes the process by
which CVM formally resolves disputes
relating to scientific controversies. A
scientific controversy involves issues
concerning a specific product regulated
by CVM related to matters of technical
expertise and requires specialized
education, training, or experience to be
understood and resolved. Further, the
E:\FR\FM\29JAN1.SGM
29JAN1
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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
guidance details information on how the
Agency intends to interpret and apply
provisions of the existing regulations
regarding internal Agency review of
decisions. In addition, the guidance
outlines the established procedures for
persons who are sponsors, applicants or
manufacturers, for animal drugs or other
products regulated by CVM, that wish to
submit a request for review of a
scientific dispute. When a sponsor,
applicant, or manufacturer has a
scientific disagreement with a written
decision by CVM, they may submit a
request for a review of that decision by
following the established Agency
channels of supervision for review.
In the Federal Register of November
6, 2014 (79 FR 65976), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
but it did not respond to any of the four
collection of information topics
solicited in the notice and therefore is
not discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
10.75 ....................................................................................
2
4
8
10
80
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
CVM encourages applicants to begin
the resolution of science-based disputes
with discussions with the review team/
group, including the Team Leader or
Division Director. The Center prefers
that differences of opinion regarding
science or science-based policy be
resolved between the review team/group
and the applicant. If the matter is not
resolved by this preferred method, then
CVM recommends that the applicant
follow the procedure in guidance for
industry #79. Of the two respondents
who were advised on the procedure
during the past 3 years, one has not
followed up to initiate it and the other
is working with the review team/group
to resolve the issue(s). Therefore, this
estimated annual reporting burden is
based on CVM’s previous experience in
handling formal appeals for scientific
disputes.
Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01669 Filed 1–28–15; 8:45 am]
BILLING CODE 4164–01–P
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 March 2,
2015.
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 0910–0052. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Blood Establishment Registration and
Product Listing, Form FDA 2830—21
CFR Part 607 (OMB Control Number
0910–0052)—Extension
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–1069]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Blood
Establishment Registration and
Product Listing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
18:16 Jan 28, 2015
Jkt 235001
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an
establishment that manufactures,
prepares, propagates, compounds, or
processes a drug or device must register
his or her name, place of business, and
all such establishments with the
Secretary of Health and Human Services
on or before December 31 of each year.
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
He or she must also submit, among
other information, a listing of all drug or
device products manufactured,
prepared, propagated, compounded, or
processed by him or her for commercial
distribution. In part 607 (21 CFR part
607), FDA has issued regulations
implementing these requirements for
manufacturers of human blood and
blood products.
Section 607.20(a), in brief, requires
owners or operators of certain
establishments that engage in the
manufacture of blood products to
register and to submit a list of every
blood product in commercial
distribution.
Section 607.21, in brief, requires the
owners or operators of establishments
entering into the manufacturing of blood
products to register within 5 days after
beginning such operation and to submit
a list of every blood product in
commercial distribution at the time. If
the owner or operator of the
establishment has not previously
entered into such operation for which a
license is required, registration must
follow within 5 days after the
submission of a biologics license
application. In addition, owners or
operators of all establishments so
engaged must register annually between
November 15 and December 31 and
update their blood product listing every
June and December.
Section 607.22 requires the use of
Form FDA 2830, Blood Establishment
Registration and Product Listing, for
initial registration, for subsequent
annual registration, and for blood
product listing information.
Section 607.25 sets forth the
information required for establishment
registration and blood product listing.
Section 607.26, in brief, requires
certain changes to be submitted on FDA
Form 2830 as an amendment to
E:\FR\FM\29JAN1.SGM
29JAN1
]]>Agencies
[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4931-4932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01669]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0509]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Appeals of Science-
Based Decisions Above the Division Level at the Center for Veterinary
Medicine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 March
2, 2015.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0566.
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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.
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.
Appeals of Science-Based Decisions Above the Division Level at CVM--21
CFR 10.75 (OMB Control Number 0910-0566--Revision)
Respondents: Respondents to this collection of information are
applicants that wish to submit a request for review of a scientific
dispute.
The Center for Veterinary Medicine's (CVM's) guidance for industry
#79 entitled ``Dispute Resolution Procedures for Science-Based
Decisions on Products Regulated by the Center for Veterinary
Medicine,'' describes the process by which CVM formally resolves
disputes relating to scientific controversies. A scientific controversy
involves issues concerning a specific product regulated by CVM related
to matters of technical expertise and requires specialized education,
training, or experience to be understood and resolved. Further, the
[[Page 4932]]
guidance details information on how the Agency intends to interpret and
apply provisions of the existing regulations regarding internal Agency
review of decisions. In addition, the guidance outlines the established
procedures for persons who are sponsors, applicants or manufacturers,
for animal drugs or other products regulated by CVM, that wish to
submit a request for review of a scientific dispute. When a sponsor,
applicant, or manufacturer has a scientific disagreement with a written
decision by CVM, they may submit a request for a review of that
decision by following the established Agency channels of supervision
for review.
In the Federal Register of November 6, 2014 (79 FR 65976), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but it did not
respond to any of the four collection of information topics solicited
in the notice and therefore is not discussed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75.............................................................. 2 4 8 10 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
CVM encourages applicants to begin the resolution of science-based
disputes with discussions with the review team/group, including the
Team Leader or Division Director. The Center prefers that differences
of opinion regarding science or science-based policy be resolved
between the review team/group and the applicant. If the matter is not
resolved by this preferred method, then CVM recommends that the
applicant follow the procedure in guidance for industry #79. Of the two
respondents who were advised on the procedure during the past 3 years,
one has not followed up to initiate it and the other is working with
the review team/group to resolve the issue(s). Therefore, this
estimated annual reporting burden is based on CVM's previous experience
in handling formal appeals for scientific disputes.
Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01669 Filed 1-28-15; 8:45 am]
BILLING CODE 4164-01-P
