Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements, 7438-7440 [E7-2578]
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7438
Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Notices
Lane, Rockville, MD 20857, 301–827–
1472.
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:
Guidance for Industry on ‘‘How To Use
E-Mail To Submit a Study Protocol’’—
21 CFR 58.120; 21 CFR 514.117(b);
(OMB Control Number 0910–0524)—
Extension
Protocols for nonclinical laboratory
studies (safety studies), are required
under 21 CFR 58.120 for approval of
new animal drugs. Protocols for
adequate and well-controlled
effectiveness studies are required under
21 CFR 514.117(b). Upon request by the
animal drug sponsors, the Center for
Veterinary Medicine (CVM), reviews
protocols for safety and effectiveness
studies that CVM and the sponsor
consider to be an essential part of the
basis for making the decision to approve
or not approve an animal drug
application or supplemental animal
drug application. Establishing a process
for acceptance of the electronic
submission of protocols for studies
conducted by sponsors in support of
new animal drug applications (NADAs),
is part of CVM’s ongoing initiative to
provide a method for paperless
submissions. Sponsors may submit
protocols to CVM in paper format.
CVM’s guidance on how to submit a
study protocol permits sponsors to
submit a protocol without data as an email attachment via the Internet. CVM’s
guidance on how to submit a study
protocol electronically implements
provisions of the Government
Paperwork Elimination Act (GPEA). The
GPEA required Federal agencies, by
October 21, 2003, to provide for the: (1)
Option of the electronic maintenance,
submission, or disclosure of
information, if practicable, as a
substitution for paper; and (2) use and
acceptance of electronic signatures,
where applicable.
FDA is also seeking an extension of an
existing paperwork clearance for form
FDA 3536 to facilitate the use of
electronic submission of protocols. This
collection of information is for the
benefit of animal drug sponsors, giving
them the flexibility to submit data for
review via the Internet.
In the Federal Register of November
8, 2006 (71 FR 65534), FDA published
a 60-day notice soliciting public
comment on the proposed collection of
information requirements. In response
to that notice, no comments were
received.
The likely respondents for this
collection of information are sponsors of
NADAs.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section/ Form No.
514.117 ( b)
58.120 / Form 3536
1There
Annual Frequency
per Response
25
Total Annual
Responses2
4.2
Hours per
Response
103
Total Hours
0.20
20.6
are no capital costs or operating and maintenance costs associated with this collection of information.
submissions received between July 1, 2005, and June 30, 2006.
2Electronic
The number of respondents in table 1
of this document is the number of
sponsors registered to make electronic
submissions (25). The number of total
annual responses is based on a review
of the actual number of such
submissions made between July 1, 2005,
and June 30, 2006. 103 x hours per
response (.20) = 20.6 total hours.
Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2577 Filed 2–14–07; 8:45 am]
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.
Fax written comments on the
collection of information by March 19,
2007.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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:
202–395–6974.
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
ADDRESSES:
BILLING CODE 4160–01–S
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
ycherry on PROD1PC64 with NOTICES
[Docket No. 2006N–0381]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Mammography
Quality Standards Act Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
18:37 Feb 14, 2007
Jkt 211001
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:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
The Mammography Quality Standards
Act Requirements—21 CFR Part 900
(OMB Control Number 0910–0309)—
Extension
Mammography Quality Standards Act
requires the establishment of a Federal
certification and inspection program for
mammography facilities; regulations
and standards for accreditation and
certification bodies for mammography
facilities, and standards for
mammography equipment, personnel,
and practices, including quality
assurance. The intent of these
regulations is to ensure safe, reliable,
and accurate mammography on a
nationwide level.
Under the regulations, as a first step
in becoming certified, mammography
facilities must become accredited by an
FDA approved accreditation body. This
requires undergoing a review of their
clinical images and providing the
accreditation body with information
showing that they meet the equipment,
personnel, quality assurance and quality
control standards, and have a medical
reporting and recordkeeping program, a
medical outcomes audit program, and a
consumer compliant mechanism. On the
basis of this accreditation, facilities are
then certified by FDA or an FDA-
E:\FR\FM\15FEN1.SGM
15FEN1
7439
Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Notices
approved State certification agency and
must prominently display their
certificate. These actions are taken to
ensure safe, accurate, and reliable
mammography on a nationwide basis.
In the Federal Register of September
22, 2006 (71 FR 55488), FDA published
a 60-day notice soliciting public
comments on the information collection
requirements of the proposed collection.
In response to that notice, no comments
were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR Section/ FDA
Form
900.3(b)(1)
900.3(b)(3) full1
900.3(b)(3) limited2
900.3(d)(2)
900.3(d)(5)
900.3(e)
900.3(f)(2)
900.4(c) facility3
900.4(c) AB4
900.4(d) facility3
900.4(d) AB4
900.4(e) facility3
900.4(e) AB4
900.4(f)
900.4(h) facility3
900.4(h) AB4
900.4(i)(2)
900.6(c)(1)
900.11(b)(3)
900.11(c)
900.12(c)(2)
900.12(c)(2) patient refusal5
900.12(h)(4)
900.12(j)(1) facility3
900.12(j)(1) AB4
900.12(j)(2)
900.15(c)
900.15(d)(3)(ii)
900.18(c)
900.18(e)
900.21(b)
900.21(c)(2)
900.22(h)
900.22(i)
900.23
900.24(a)
900.24(a)(2)
900.24(b)
900.24(b)(1)
900.24(b)(3)
900.25(a)
FDA Form 3422
TOTAL
1
2
3
4
5
Refers
Refers
Refers
Refers
Refers
to
to
to
to
to
Annual Frequency per
Response
No. of Respondents
Total Annual
Responses
Hours per Response
Total Hours
0.33
0.33
5
0.1
0.1
0.1
0.1
2,947
6
2,947
6
8,840
6
336
8,840
6
1
0.1
5
270
8,840
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
4,072
0.33
0.33
5
0.1
0.1
0.1
0.1
2,947
6
2,947
6
8,840
6
336
8,840
6
1
0.1
5
270
36,000,000
1
320
30
30
30
1
200
1.54
378
0.77
189
1
1,473
7
1
10
16
60
0.5
5
0.083
0.33
106
150
3
3
0.1
20
4,538
2,268
2,269
1,134
8,840
8,838
2,352
8,840
60
16
6
2.5
1,350
3,000,000
89
5
25
25
3
5
1
2
2
1
0.3
6
2
6
0.3
0.15
1.2
0.3
0.15
0.2
700
1
1
1
1
1
1
1
1
1
1
1
200
1
1
1
1
1
1
1
1
1
89
5
25
25
3
5
1
2
2
1
0.33
1,200
2
6
0.3
0.15
1.2
0.3
0.15
0.2
700
0.5
1
200
1,000
100
2
2
2
1
320
30
0.083
30
20
200
100
30
200
100
16
0.25
44.5
5
5,000
25,000
300
10
2
4
2
320
10
100
60
120
60
15
36
60
15
3.2
175
3,072,138
Total Capital Costs
Total Operating &
Maintenance
Costs
$10,000
$36
$117,867
$8,840
$77,840
$3,536
$14,400,0005
$250
$750
$3,604
$30,000
$71
$26
$13
$26
$13
$40,000
$14,612,872
entities that are applying for the first time.
accreditation bodies applying to accredit specific Full Field Digital Mammography units.
the facility component of the burden for this requirement.
the accreditation body component of the burden for this requirement.
the situation where a patient specifically does not want to receive the lay summary of her exam.
TABLE 2. —ESTIMATED ANNUAL RECORDKEEPING BURDEN
ycherry on PROD1PC64 with NOTICES
21 CFR Section
Number of
Recordkeepers
900.4(g)
900.12(a)(1)(i)(B)(2)
900.12(a)(4)
900.12(c)(4)
900.12(e)(13)
900.12(f)
900.12(h)(2)
VerDate Aug<31>2005
18:37 Feb 14, 2007
Annual Frequency of
Recordkeeping
6
89
8,840
8,840
8,840
8,840
8,840
Jkt 211001
Total Annual
Records
1
1
4
1
52
1
2
PO 00000
Frm 00053
Hours per
Record
6
89
35,360
8,840
459,680
8,840
17,680
Fmt 4703
Sfmt 4703
1
8
1
1
0.083
16
1
Total Hours
6
712
35,360
8,840
38,154
141,440
17,680
E:\FR\FM\15FEN1.SGM
15FEN1
Total Capital
Costs
$25,000
Total Operating &
Maintenance Costs
7440
Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Notices
TABLE 2. —ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
21 CFR Section
Number of
Recordkeepers
900.22(a)
900.22(d)
900.22(e)
900.22(f)
900.22(g)
900.25(b)
Total
Annual Frequency of
Recordkeeping
6
6
6
3
6
6
Total Annual
Records
1
1
1
1
1
1
This request for OMB approval now
serves to consolidate previously issued
information collection, OMB control
number 0910–0580 into 0910–0309. The
hourly burden as well as the associated
operating costs were increased to better
represent the actual burden and costs on
facilities and accreditation bodies.
The following regulations were not
included in the above burden tables
because they were considered usual and
customary practice and were part of the
standard of care prior to the
implementation of the regulations.
Therefore, they resulted in no additional
reporting or recordkeeping burden: 21
CFR 900.12(c)(1) and (c)(3) and
§ 900.3(f)(1) (21 CFR 900.3(f)(1)).
The following regulations were not
included in the above burden tables
because they were not considered
applicable during the information
collection period or their burdens were
reported under other regulatory
requirements. Therefore, they resulted
in no additional reporting or
recordkeeping burden: § 900.3(c), 21
CFR 900.11(b)(1) and (b)(2), and
900.24(c).
Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2578 Filed 2–14–07; 8:45 am]
BILLING CODE 4160–01–S
Hours per
Record
6
6
6
3
6
6
Total Hours
1
1
1
1
1
1
6
6
6
3
6
6
242,225
$25,000
$60
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food and Drug Administration
[Docket No. 2006N–0434]
How to Use E-Mail to Submit a Request
for a Meeting or Teleconference to the
Office Of New Animal Drug
Evaluation—21 CFR 10.65 (OMB
Control Number 0910–0452)—Extension
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on How to Use E-Mail to
Submit a Request for a Meeting or
Teleconference to the Office Of New
Animal Drug Evaluation
Food and Drug Administration,
HHS.
ACTION:
$60
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Total Operating &
Maintenance Costs
Total Capital
Costs
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 19,
2007.
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:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
The Center for Veterinary Medicine
(CVM) holds meetings and /or
teleconferences when a sponsor requests
a presubmission conference under 21
CFR 514.5, or requests a meeting to
discuss general questions. Generally,
meeting requests are submitted to CVM
on paper. However, CVM now allows
registered sponsors to submit
information electronically, and to
request meetings electronically, if they
determine this is more efficient and
time saving for them. CVM’s guidance
‘‘On How to Use E-Mail to Submit a
Request for a Meeting or Teleconference
to the Office of New Animal Drug
Evaluation’’ provides sponsors with the
option to submit a request for a meeting
or teleconference as an e-mail
attachment via the internet.
In the Federal Register of November
8, 2006 (71 FR 65535), FDA published
a 60-day notice soliciting comments on
the proposed collection of information
requirements. In response to that notice,
no comments were received.
The likely respondents are sponsors
for new animal drug applications.
CVM estimates the burden for this
information collection activity as
follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Respondents
ycherry on PROD1PC64 with NOTICES
21 CFR Section/FDA Form #
10.65/FDA Form 3489
1There
Annual Frequency
per Response
25
Total Annual Responses2
6.24
156
are no capital costs or operating and maintenance costs associated with this collection of information.
submissions received between July 1, 2005 and June 30, 2006.
2Electronic
VerDate Aug<31>2005
18:37 Feb 14, 2007
Jkt 211001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
E:\FR\FM\15FEN1.SGM
15FEN1
Hours per Response
.08
Total Hours
12.5
]]>Agencies
[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Notices]
[Pages 7438-7440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2578]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0381]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Mammography Quality
Standards Act Requirements
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
19, 2007.
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: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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.
The Mammography Quality Standards Act Requirements--21 CFR Part 900
(OMB Control Number 0910-0309)--Extension
Mammography Quality Standards Act requires the establishment of a
Federal certification and inspection program for mammography
facilities; regulations and standards for accreditation and
certification bodies for mammography facilities, and standards for
mammography equipment, personnel, and practices, including quality
assurance. The intent of these regulations is to ensure safe, reliable,
and accurate mammography on a nationwide level.
Under the regulations, as a first step in becoming certified,
mammography facilities must become accredited by an FDA approved
accreditation body. This requires undergoing a review of their clinical
images and providing the accreditation body with information showing
that they meet the equipment, personnel, quality assurance and quality
control standards, and have a medical reporting and recordkeeping
program, a medical outcomes audit program, and a consumer compliant
mechanism. On the basis of this accreditation, facilities are then
certified by FDA or an FDA-
[[Page 7439]]
approved State certification agency and must prominently display their
certificate. These actions are taken to ensure safe, accurate, and
reliable mammography on a nationwide basis.
In the Federal Register of September 22, 2006 (71 FR 55488), FDA
published a 60-day notice soliciting public comments on the information
collection requirements of the proposed collection. In response to that
notice, no comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Total
21 CFR Section/ FDA Form No. of Frequency per Total Annual Hours per Total Hours Capital Total Operating &
Respondents Response Responses Response Costs Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.3(b)(1) 0.33 1 0.33 1 0.33 ........... .................
900.3(b)(3) full\1\ 0.33 1 0.33 320 106 $10,000 .................
900.3(b)(3) limited\2\ 5 1 5 30 150 ........... .................
900.3(d)(2) 0.1 1 0.1 30 3 ........... .................
900.3(d)(5) 0.1 1 0.1 30 3 ........... .................
900.3(e) 0.1 1 0.1 1 0.1 ........... .................
900.3(f)(2) 0.1 1 0.1 200 20 ........... $36
900.4(c) facility\3\ 2,947 1 2,947 1.54 4,538 ........... .................
900.4(c) AB\4\ 6 1 6 378 2,268 ........... $117,867
900.4(d) facility\3\ 2,947 1 2,947 0.77 2,269 ........... .................
900.4(d) AB\4\ 6 1 6 189 1,134 ........... .................
900.4(e) facility\3\ 8,840 1 8,840 1 8,840 ........... $8,840
900.4(e) AB\4\ 6 1 6 1,473 8,838 ........... .................
900.4(f) 336 1 336 7 2,352 ........... $77,840
900.4(h) facility\3\ 8,840 1 8,840 1 8,840 ........... $3,536
900.4(h) AB\4\ 6 1 6 10 60 ........... .................
900.4(i)(2) 1 1 1 16 16 ........... .................
900.6(c)(1) 0.1 1 0.1 60 6 ........... .................
900.11(b)(3) 5 1 5 0.5 2.5 ........... .................
900.11(c) 270 1 270 5 1,350 ........... .................
900.12(c)(2) 8,840 4,072 36,000,000 0.083 3,000,000 ........... $14,400,000\5\
900.12(c)(2) patient refusal\5\ 89 1 89 0.5 44.5 ........... .................
900.12(h)(4) 5 1 5 1 5 ........... .................
900.12(j)(1) facility\3\ 25 1 25 200 5,000 ........... $250
900.12(j)(1) AB\4\ 25 1 25 1,000 25,000 ........... $750
900.12(j)(2) 3 1 3 100 300 ........... $3,604
900.15(c) 5 1 5 2 10 ........... .................
900.15(d)(3)(ii) 1 1 1 2 2 ........... .................
900.18(c) 2 1 2 2 4 ........... .................
900.18(e) 2 1 2 1 2 ........... .................
900.21(b) 1 1 1 320 320 $30,000 $71
900.21(c)(2) 0.3 1 0.33 30 10 ........... .................
900.22(h) 6 200 1,200 0.083 100 ........... .................
900.22(i) 2 1 2 30 60 ........... .................
900.23 6 1 6 20 120 ........... .................
900.24(a) 0.3 1 0.3 200 60 ........... $26
900.24(a)(2) 0.15 1 0.15 100 15 ........... $13
900.24(b) 1.2 1 1.2 30 36
900.24(b)(1) 0.3 1 0.3 200 60 ........... $26
900.24(b)(3) 0.15 1 0.15 100 15 ........... $13
900.25(a) 0.2 1 0.2 16 3.2 ........... .................
FDA Form 3422 700 1 700 0.25 175 ........... .................
TOTAL .............. .............. .............. .............. 3,072,138 $40,000 $14,612,872
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Refers to entities that are applying for the first time.
\2\ Refers to accreditation bodies applying to accredit specific Full Field Digital Mammography units.
\3\ Refers to the facility component of the burden for this requirement.
\4\ Refers to the accreditation body component of the burden for this requirement.
\5\ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
Table 2. --Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total Annual Hours per Total Capital Operating &
21 CFR Section Recordkeepers Frequency of Records Record Total Hours Costs Maintenance
Recordkeeping Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(g) 6 1 6 1 6 ................. ...........
900.12(a)(1)(i)(B)(2) 89 1 89 8 712 ................. ...........
900.12(a)(4) 8,840 4 35,360 1 35,360 ................. ...........
900.12(c)(4) 8,840 1 8,840 1 8,840 $25,000 ...........
900.12(e)(13) 8,840 52 459,680 0.083 38,154 ................. ...........
900.12(f) 8,840 1 8,840 16 141,440 ................. ...........
900.12(h)(2) 8,840 2 17,680 1 17,680 ................. ...........
[[Page 7440]]
900.22(a) 6 1 6 1 6 ................. ...........
900.22(d) 6 1 6 1 6 ................. ...........
900.22(e) 6 1 6 1 6 ................. ...........
900.22(f) 3 1 3 1 3 ................. ...........
900.22(g) 6 1 6 1 6 ................. $60
900.25(b) 6 1 6 1 6 ................. ...........
Total .............. .............. .............. .............. 242,225 $25,000 $60
--------------------------------------------------------------------------------------------------------------------------------------------------------
This request for OMB approval now serves to consolidate previously
issued information collection, OMB control number 0910-0580 into 0910-
0309. The hourly burden as well as the associated operating costs were
increased to better represent the actual burden and costs on facilities
and accreditation bodies.
The following regulations were not included in the above burden
tables because they were considered usual and customary practice and
were part of the standard of care prior to the implementation of the
regulations. Therefore, they resulted in no additional reporting or
recordkeeping burden: 21 CFR 900.12(c)(1) and (c)(3) and Sec.
900.3(f)(1) (21 CFR 900.3(f)(1)).
The following regulations were not included in the above burden
tables because they were not considered applicable during the
information collection period or their burdens were reported under
other regulatory requirements. Therefore, they resulted in no
additional reporting or recordkeeping burden: Sec. 900.3(c), 21 CFR
900.11(b)(1) and (b)(2), and 900.24(c).
Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2578 Filed 2-14-07; 8:45 am]
BILLING CODE 4160-01-S
