Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13; Availability, 70011-70013 [2010-28762]
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Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
Scanningless Multiphoton Microscopy
with Diffraction-Limited Axial
Resolution
Description of Invention: The
technology offered for licensing is a
scanningless multiphoton microscope
for performing 3-dimensional imaging
that achieves diffraction-limited
resolution. The microscope combines
temporal multiplexing with spatial
dispersion to achieve diffraction-limited
resolution without having to
mechanically scan the sample (a field of
view up to 30x30 microns). The widefield excitation of the sample allows
imaging rates in excess to prior art
multiphoton microscopes while still
achieving diffraction-limited axial
resolution. The microscope includes a
laser source that generates a
femtosecond laser beam that passes
through a stair-step optic having a
variable thickness piece of glass
arranged such that each ‘‘strip’’ of the
laser beam is delivered at a different
relative delay. Each strip exits the stairstep optic and is imaged onto the
surface of a diffraction grating by two
imaging lenses and a mirror. The
diffraction grating sends the different
wavelengths that compose each
horizontal strip of the laser beam in
different directions. Another pair of
lenses, such as the imaging lens and
objective lens (e.g., high numerical
aperture objective) images and demagnifies the surface of the diffractive
grating into a biological sample that
causes an excitation to occur in the
sample. The ensuing excitation
generates fluorescence in the sample
confined to the focal plane of the
objective lens, where the excitation is
maximized. The fluorescence is
collected through the objective lens and
then by a CCD camera.
Applications:
• The invention provides a high
resolution multiphoton microscopy
device to the laboratory instrumentation
market.
• The uses of such a device would
predominantly be for research in
biological imaging.
• The device provides the ability to
image a large frame rapidly and with
relatively low energy and thus without
burning the sample or destroying
subcellular structures.
Inventors: Hari Shroff and Andrew
York (NIBIB).
Patent Status: U.S. Provisional
Application No. 61/385,409 filed 22 Sep
2010 (HHS Reference No. E–105–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contacts:
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19:33 Nov 15, 2010
Jkt 223001
• Uri Reichman, Ph.D., MBA; 301–
435–4616; UR7a@nih.gov.
• Michael Shmilovich, Esq.; 301–
435–5019; ShmilovichM@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Biomedical
Imaging and Bioengineering Section on
High Resolution Optical Imaging is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
invention. Please contact Dr. Henry
Eden at edenh@mail.nih.gov for more
information.
Myosin-Based Protein-Protein
Interaction Assay
Description of Invention: Investigators
at the National Institute on Deafness and
Other Communication Disorders
(NIDCD) have developed an assay for
the detection of protein-protein
interactions in living cells. This assay
uses readily-available reagents and
straightforward techniques that avoid
the difficulty of purifying proteins or
generating antibodies required for other
binding studies. Proof-of-concept for
this assay has been demonstrated, and a
manuscript is in preparation for
publication.
This technology utilizes a molecular
motor, myosin X, which migrates along
actin filaments within cells. A protein
fused to a fragment of myosin X will
carry its binding partners to the cell
periphery. Since the myosin fusion
protein and its partner are labeled with
different fluorescent tags, an
unambiguous fluorescence overlap will
be visible as discrete points along the
periphery of the cell. The inventors
have designed a number of cDNAs for
the construction of fusion proteins
appropriate for such an assay.
Available for licensing are a variety of
cDNAs which may be used for
generating fluorescently-tagged myosin
X fusion proteins, for use in the assay
described above. Also available are a
number of constructs incorporating
other fluorescently-tagged myosins,
kinesins, myosin and kinesin binding
partners and a variety of PDZ scaffold
proteins. Further details of the available
cDNAs are available upon request.
Applications:
• Identification of protein-protein
binding interactions in living cells.
• DNA-based tools for study of
myosins, trafficking, signaling
complexes and other research focusing
on molecular motors.
Advantages:
• Assay avoids the need to purify
proteins or generate antibodies for
binding studies.
PO 00000
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70011
• Protein-protein interactions can be
unambiguously identified.
Development Status: Proof of concept
has been demonstrated.
Inventors: Erich T. Boger, Inna A.
Belyantseva, Thomas B. Friedman
(NIDCD).
Relevant Publication: Belyantseva IA
et al. Myosin-XVa is required for tip
localization of whirlin and differential
elongation of hair-cell stereocilia. Nat
Cell Biol. 2005 Feb;7(2):148–156.
[PubMed: 15654330]
Patent Status: HHS Reference Nos. E–
069–2009/0, E–069–2009/1, E–069–
2009/2, E–069–2009/3, E–069–2009/4,
E–069–2009/5, E–069–2009/6, and E–
069–2009/7—Research Tool. Patent
protection is not being sought for this
invention.
Licensing Status: Available for
licensing under a Biological Materials
License Agreement.
Licensing Contact: Tara L. Kirby,
Ph.D.; 301–435–4426;
tarak@mail.nih.gov.
Dated: November 9, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–28847 Filed 11–15–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0448]
Guidance for Industry, Mammography
Quality Standards Act Inspectors, and
Food and Drug Administration Staff;
The Mammography Quality Standards
Act Final Regulations: Modifications
and Additions to Policy Guidance Help
System #13; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘The Mammography Quality Standards
Act Final Regulations: Modifications
and Additions to Policy Guidance Help
System #13.’’ This document is intended
to assist mammography facilities and
their personnel in meeting the
requirements of the Mammography
Quality Standards Act (MQSA)
regulations.
SUMMARY:
Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
DATES:
E:\FR\FM\16NON1.SGM
16NON1
70012
Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘The Mammography Quality
Standards Act Final Regulations:
Modifications and Additions to Policy
Guidance Help System #13’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance,
Center for Devices and Radiological
Health (CDRH), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4613, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Charles Finder, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4646, Silver Spring,
MD 20993–0002, 301–796–5710.
SUPPLEMENTARY INFORMATION:
I. Background
MQSA (Pub. L. 102–539) was signed
into law on October 27, 1992, to
establish national quality standards for
mammography. It is codified at 42
U.S.C. 263b. The MQSA requires that, in
order to lawfully provide
mammography services after October 1,
1994, all facilities, except facilities of
the Department of Veterans Affairs,
must be accredited by an approved
accreditation body and certified by the
Secretary of Health and Human Services
(the Secretary) or by an approved State
certification Agency (section 354(b) of
the MQSA, (42 U.S.C. 263b(b))). In June
1993, the authority to approve
accreditation bodies and State
certification agencies and to certify
facilities was delegated by the Secretary
to FDA (June 10, 1993, 58 FR 32543). On
October 28, 1997, FDA first published
final regulations implementing the
MQSA in the Federal Register (part 900
(21 CFR part 900)). The MQSA has
twice been amended since its
enactment, through the Mammography
Quality Standards Reauthorization Acts
of 1998 and 2004 (Pub. L. 105–248 and
108–365).
VerDate Mar<15>2010
19:33 Nov 15, 2010
Jkt 223001
This guidance updates the Policy
Guidance Help System (PGHS) and
addresses or contains the following:
1. Updated contact information for
accreditation bodies and certification
agencies;
2. General guidance regarding
Additional Mammography Reviews;
3. Previously approved alternative
standards;
4. Centers for Medicare and Medicaid
Services reimbursement;
5. Mechanisms to inform physicians
and patients of mammography results;
6. Mammographic modality and its
impact on personnel requirements;
7. Clarification of the personnel 6month exemption period;
8. Information on calibrating the air
kerma measuring instrument;
9. Medical physicist involvement as it
applies to cassette replacement;
10. Full Field Digital Mammography
(FFDM) and use of single-use cushion
pads;
11. Quality control testing of
computer controlled compression
devices;
12. Mammography equipment
evaluations of laser printers;
13. Quality control testing of monitors
and laser printers;
14. Mammography equipment
evaluations of new FFDM units; and
15. Mammography equipment
evaluations of off-site laser printers and
monitors.
The draft of this guidance was made
available in the Federal Register of
October 9, 2009 (74 FR 52242). The
comment period closed on January 7,
2010. During the public comment
period, 4 respondents submitted a total
of 14 comments. In addition, the
National Mammography Quality
Assurance Advisory Committee
reviewed the draft guidance during its
January 25, 2010, meeting and provided
additional comments. FDA reviewed
and considered all the comments and in
response FDA has modified the draft
guidance as follows by:
1. Providing the most current
accreditation body and certification
Agency contact information;
2. Clarifying that original or lossless
compressed digital image files may be
acceptable for record transfer;
3. Clarifying the conditions under
which an Additional Mammography
Review conducted by an outside entity
would be acceptable to FDA;
4. Deleting the question and answer
dealing with image labeling;
5. Modifying the section on the use of
attestation to include attesting to the
specific mammographic modality
included in personnel’s initial training;
PO 00000
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Fmt 4703
Sfmt 4703
6. Clarifying the guidance on the use
of non-invasive kilovolts peak (kVp)
meters; and
7. Recommending the inclusion of
cushion pad(s) when performing
automatic exposure control testing.
In November 1998, FDA compiled all
to-date final FDA guidances related to
MQSA and put them into a
computerized searchable database
called the PGHS. The PGHS is available
on the Internet at: https://www.fda.gov/
Radiation-EmittingProducts/
MammographyQualityStandardsAct
andProgram/Guidance/
PolicyGuidanceHelpSystem/
default.htm.
FDA periodically updates the
information in the PGHS and this
document serves as a further update.
Individuals wishing to receive
automatic notification of future updates
may subscribe to our E-mail ListServ by
visiting https://service.govdelivery.com/
service/subscribe.html?code=USFDA_45
and following the directions.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘The Mammography Quality
Standards Act Final Regulations:
Modifications and Additions to Policy
Guidance Help System #13,’’ you may
either send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1695 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
E:\FR\FM\16NON1.SGM
16NON1
Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 900 have been approved under
OMB control number 0910–0309.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: November 10, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2010–28762 Filed 11–15–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1344–CN]
RIN 0938–AP89
Medicare Program; Inpatient
Rehabilitation Facility Prospective
Payment System for Federal Fiscal
Year 2011; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction notice.
AGENCY:
This document corrects a
technical error that appeared in the
notice published in the July 22, 2010
Federal Register entitled, ‘‘Inpatient
Rehabilitation Facility Prospective
Payment System for Federal Fiscal Year
2011.’’
DATES: Effective Date. This correction is
effective for IRF discharges occurring on
or after October 1, 2010 and on or before
September 30, 2011.
FOR FURTHER INFORMATION CONTACT:
Susanne Seagrave, (410) 786–0044.
SUPPLEMENTARY INFORMATION:
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
I. Background
In FR Doc. 2010–17621 of July 22,
2010 (75 FR 42836), there was a
technical error that we are identifying
and correcting in the ‘‘Correction of
Errors’’ section below. The provisions in
this correction notice are effective as if
they had been included in the document
published July 22, 2010. Accordingly,
VerDate Mar<15>2010
19:33 Nov 15, 2010
Jkt 223001
the corrections are effective October 1,
2010.
II. Summary of Errors
In the July 22, 2010 notice (75 FR
42836), we applied our established
formula for calculating the national
cost-to-charge (CCR) ceiling. Using that
formula, the national CCR ceiling
should have been calculated to be 1.61.
It was inadvertently listed on page
42856 as 2.94 due to a calculation error.
Thus, we are correcting page 42856 to
reflect the correct result of the
application of the established formula.
The corrected national CCR ceiling is
1.61 for FY 2011.
III. Correction of Errors
In FR Doc. 2010—17621 of July 22,
2010 (75 FR 42836), make the following
corrections:
1. On page 42856, in column 1, in line
23 from the top of the page, the value
‘‘2.94’’ is corrected to read ‘‘1.61.’’
2. On page 42856, in column 1, in line
25 from the top of the page, the value
‘‘2.94’’ is corrected to read ‘‘1.61.’’
IV. Waiver of Proposed Rulemaking
and Delayed Effective Date
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register to provide a period for public
comment before the provisions of a rule
take effect in accordance with section
553(b) of the Administrative Procedure
Act (APA) (5 U.S.C. 553(b)). We also
ordinarily provide a 30-day delay in the
effective date of the provisions of a rule
in accordance with section 553(d) of the
APA (5 U.S.C. 553(d)). However, we can
waive both notice and comment
procedures and the 30-day delay in
effective date if the Secretary finds, for
good cause, that such procedures are
impracticable, unnecessary, or contrary
to the public interest, and incorporates
a statement of the finding and the
reasons into the notice.
The policies and payment
methodology expressed in the FY 2011
IRF PPS notice (75 FR 42836) have
previously been subjected to notice and
comment procedures. This correction
notice merely provides a technical
correction to the FY 2011 notice, and
does not make substantive changes to
the policies or payment methodologies
that were expressed in that notice.
Therefore, we find it unnecessary to
undertake further notice and comment
procedures with respect to this
correction notice. We also believe that it
is in the public interest (and would be
contrary to the public interest to do
otherwise) to waive notice and comment
procedures and the 30-day delay in
effective date for this notice. This
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70013
correction notice is intended to ensure
that the FY 2011 IRF PPS notice
accurately reflects the payment
methodologies and policies expressed in
the notice, and that the correct
information is made available to the
public. Therefore, we find good cause to
waive notice and comment procedures
and the 30-day delay in the effective
date for this correction notice.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: November 9, 2010.
Dawn L. Smalls,
Executive Secretary to the Department.
[FR Doc. 2010–28814 Filed 11–15–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
President’s Cancer Panel.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: President’s Cancer
Panel.
Date: December 14, 2010.
Time: 8 a.m. to 4:45 p.m.
Agenda: The Future of Cancer Research:
Accelerating Scientific Innovation.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6C10, Bethesda,
MD 20892.
Contact Person: Abby B. Sandler, PhD,
Executive Secretary, Chief, Institute Review
Office, Office of the Director, 6116 Executive
Blvd., Suite 220, MSC 8349, National Cancer
Institute, NIH, Bethesda, MD 20892–8349,
(301) 451–9399, sandlera@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70011-70013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28762]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0448]
Guidance for Industry, Mammography Quality Standards Act
Inspectors, and Food and Drug Administration Staff; The Mammography
Quality Standards Act Final Regulations: Modifications and Additions to
Policy Guidance Help System 13; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``The Mammography Quality
Standards Act Final Regulations: Modifications and Additions to Policy
Guidance Help System 13.'' This document is intended to assist
mammography facilities and their personnel in meeting the requirements
of the Mammography Quality Standards Act (MQSA) regulations.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency
[[Page 70012]]
guidance documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``The Mammography Quality Standards Act Final
Regulations: Modifications and Additions to Policy Guidance Help System
13'' to the Division of Small Manufacturers, International,
and Consumer Assistance, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Charles Finder, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4646, Silver Spring, MD 20993-0002, 301-796-5710.
SUPPLEMENTARY INFORMATION:
I. Background
MQSA (Pub. L. 102-539) was signed into law on October 27, 1992, to
establish national quality standards for mammography. It is codified at
42 U.S.C. 263b. The MQSA requires that, in order to lawfully provide
mammography services after October 1, 1994, all facilities, except
facilities of the Department of Veterans Affairs, must be accredited by
an approved accreditation body and certified by the Secretary of Health
and Human Services (the Secretary) or by an approved State
certification Agency (section 354(b) of the MQSA, (42 U.S.C. 263b(b))).
In June 1993, the authority to approve accreditation bodies and State
certification agencies and to certify facilities was delegated by the
Secretary to FDA (June 10, 1993, 58 FR 32543). On October 28, 1997, FDA
first published final regulations implementing the MQSA in the Federal
Register (part 900 (21 CFR part 900)). The MQSA has twice been amended
since its enactment, through the Mammography Quality Standards
Reauthorization Acts of 1998 and 2004 (Pub. L. 105-248 and 108-365).
This guidance updates the Policy Guidance Help System (PGHS) and
addresses or contains the following:
1. Updated contact information for accreditation bodies and
certification agencies;
2. General guidance regarding Additional Mammography Reviews;
3. Previously approved alternative standards;
4. Centers for Medicare and Medicaid Services reimbursement;
5. Mechanisms to inform physicians and patients of mammography
results;
6. Mammographic modality and its impact on personnel requirements;
7. Clarification of the personnel 6-month exemption period;
8. Information on calibrating the air kerma measuring instrument;
9. Medical physicist involvement as it applies to cassette
replacement;
10. Full Field Digital Mammography (FFDM) and use of single-use
cushion pads;
11. Quality control testing of computer controlled compression
devices;
12. Mammography equipment evaluations of laser printers;
13. Quality control testing of monitors and laser printers;
14. Mammography equipment evaluations of new FFDM units; and
15. Mammography equipment evaluations of off-site laser printers
and monitors.
The draft of this guidance was made available in the Federal
Register of October 9, 2009 (74 FR 52242). The comment period closed on
January 7, 2010. During the public comment period, 4 respondents
submitted a total of 14 comments. In addition, the National Mammography
Quality Assurance Advisory Committee reviewed the draft guidance during
its January 25, 2010, meeting and provided additional comments. FDA
reviewed and considered all the comments and in response FDA has
modified the draft guidance as follows by:
1. Providing the most current accreditation body and certification
Agency contact information;
2. Clarifying that original or lossless compressed digital image
files may be acceptable for record transfer;
3. Clarifying the conditions under which an Additional Mammography
Review conducted by an outside entity would be acceptable to FDA;
4. Deleting the question and answer dealing with image labeling;
5. Modifying the section on the use of attestation to include
attesting to the specific mammographic modality included in personnel's
initial training;
6. Clarifying the guidance on the use of non-invasive kilovolts
peak (kVp) meters; and
7. Recommending the inclusion of cushion pad(s) when performing
automatic exposure control testing.
In November 1998, FDA compiled all to-date final FDA guidances
related to MQSA and put them into a computerized searchable database
called the PGHS. The PGHS is available on the Internet at: https://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/default.htm.
FDA periodically updates the information in the PGHS and this
document serves as a further update. Individuals wishing to receive
automatic notification of future updates may subscribe to our E-mail
ListServ by visiting https://service.govdelivery.com/service/subscribe.html?code=USFDA_45 and following the directions.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. To receive
``The Mammography Quality Standards Act Final Regulations:
Modifications and Additions to Policy Guidance Help System
13,'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number 1695 to identify the guidance you are requesting.
IV. Paperwork Reduction Act
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork
[[Page 70013]]
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 900 have been approved under OMB control number
0910-0309.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 10, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28762 Filed 11-15-10; 8:45 am]
BILLING CODE 4160-01-P
