[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76417-76422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31341]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0608]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; MedWatch: The Food
and Drug Administration Medical Products Reporting Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 January
6, 2012.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0291.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, (301)
796-3794, [email protected].
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.
[[Page 76418]]
MedWatch: The FDA Medical Products Reporting Program--(OMB Control
Number 0910-0291)--Extension
I. Background
To ensure the marketing of safe and effective products,
postmarketing adverse outcomes and product problems must be reported
for all FDA-regulated human health care products, including drugs, both
prescription and over-the-counter (OTC); biologics; medical devices;
dietary supplements and other special nutritional products (e.g.,
infant formula and medical foods); and cosmetics. In addition, FDA has
regulatory responsibility for tobacco products and an interest in
receiving reports about adverse outcomes and product problems for these
products.
Under sections 505, 512, 513, 515, 519 and 903 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355, 360b, 360c, 360e,
360i and 393) and section 351 of the Public Health Service Act (42
U.S.C. 262), FDA has the responsibility to ensure the safety and
effectiveness of drugs, biologics, and devices. Under section 502(a) of
the FD&C Act (21 U.S.C. 352(a)), a drug or device is misbranded if its
labeling is false or misleading. Under section 502(f)(2) of the FD&C
Act, it is misbranded if it fails to bear adequate warnings, and under
section 502(j), it is misbranded if it is dangerous to health when used
as directed in its labeling. Under section 502(t)(2) of the FD&C Act,
devices are considered to be misbranded if there has been a failure or
refusal to give required notification or to furnish required material
or information required under section 519. Requirements regarding
mandatory reporting of adverse events or product problems have been
codified in parts 310, 314, 600, and 803 (21 CFR 310, 314, 600, and
803), specifically Sec. Sec. 310.305, 314.80, 314.98, 600.80, 803.30,
803.50, 803.53, 803.56, and specified in sections 760 and 761 of the
FD&C Act (21 U.S.C. 379aa and 379aa-1). Mandatory reporting of adverse
reactions for human cells, tissues, and cellular and tissue-based
products (HCT/Ps) has been codified in 21 CFR 1271.350.
FDA regulates the safety (i.e., adulteration) of dietary
supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary
supplements do not require premarket approval by FDA and the Agency
bears the burden to gather and review evidence that a dietary
supplement may be adulterated under section 402 of the FD&C Act after
that product is marketed. Under section 761(b)(1) of the FD&C Act, a
dietary supplement manufacturer, packer, or distributor whose name
appears on the label of a dietary supplement marketed in the United
States is required to submit to FDA any serious adverse event report it
receives regarding use of the dietary supplement in the United States.
Mandatory reporting, since 1993, has been supplemented by voluntary
reporting by health care professionals, their patients, and consumers
via the MedWatch reporting process. To carry out its responsibilities,
the Agency needs to be informed when an adverse event, product problem,
error with use of a human medical product or evidence of therapeutic
failure (inequivalence) is suspected or identified in clinical use.
When FDA receives this information from either health care
professionals or patients, the report becomes data that will be used to
assess and evaluate the risk associated with the product, and then take
whatever action is necessary to reduce, mitigate, or eliminate the
public's exposure to the risk through regulatory and public health
interventions.
To implement these provisions for reporting on human medical
products during their postapproval and marketed lifetimes, two forms
are available from the Agency. FDA Form 3500 is used for voluntary
(i.e., not mandated by law or regulation) reporting by health care
professionals and the public. FDA Form 3500A is used for mandatory
reporting (i.e., required by law or regulation).
Respondents to this collection of information are health care
professionals; medical care organizations and other user-facilities
(e.g., extended care facilities, ambulatory surgical centers);
consumers; manufacturers of biological, dietary supplement, and drug
products or medical devices; and importers.
II. Use of FDA Form 3500 (Voluntary Version)
The voluntary version of the form is used to submit all reports not
mandated by Federal law or regulation. Individual health professionals
are not required by law or regulation to submit reports to the Agency
or the manufacturer, with the exception of certain adverse reactions
following immunization with vaccines as mandated by the National
Childhood Vaccine Injury Act of 1986. Those mandatory reports are not
submitted to FDA on the 3500 or 3500A form but are submitted to the
joint FDA/Centers for Disease Control and Prevention Vaccines Adverse
Event Reporting System (VAERS) on the VAERS-1 form (see http://vaers.hhs.gov/resources/vaers_form.pdf).
Hospitals are not required by Federal law or regulation to submit
reports associated with drug products, biological products, or special
nutritional products. However, hospitals and other user facilities are
required by Federal law to report medical device-related deaths and
serious injuries.
Under Federal law and regulation (section 761(b)(1) of the FD&C
Act), a dietary supplement manufacturer, packer, or distributor whose
name appears on the label of a dietary supplement marketed in the
United States is required to submit to FDA any serious adverse event
report it receives regarding use of the dietary supplement in the
United States. However, FDA bears the burden to gather and review
evidence that a dietary supplement may be adulterated under section 402
of the FD&C Act after that product is marketed. Therefore, the Agency
depends on the voluntary reporting by health professionals and
especially by consumers of suspected serious adverse events and product
quality problems associated with the use of dietary supplements.
III. Use of FDA Form 3500A (Mandatory Version)
A. Drug and Biologic Products
In sections 505(j) and 704 (21 U.S.C. 374) of the FD&C Act,
Congress has required that important safety information relating to all
human prescription drug products be made available to the FDA so that
it can take appropriate action to protect the public health when
necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the FD&C Act. These
statutory requirements regarding mandatory reporting have been codified
by FDA under 21 parts 310 and 314 (drugs) and 600 (biologics) of the
Code of Federal Regulations. Parts 310, 314, and 600 mandate the use of
FDA Form 3500A for reporting to FDA on adverse events that occur with
drugs and biologics. Mandatory reporting of adverse reactions for HCT/
Ps has been codified in 21 CFR 1271.350.
The majority of the mandatory reports for drug products, which at
inception of FDA Form 3500A's use were received by the Agency on the
paper version of FDA Form 3500A (by mail or FAX), are now submitted and
received by the Agency via an electronic submission route. In that
case, the FDA Form 3500A is not used.
B. Medical Device Products
Section 519 of the FD&C Act requires manufacturers and importers of
devices
[[Page 76419]]
intended for human use to establish and maintain records, make reports,
and provide information as the Secretary of Health and Human Services
may by regulation reasonably require to assure that such devices are
not adulterated or misbranded and to otherwise assure its safety and
effectiveness. The Safe Medical Device Act of 1990, signed into law on
November 28, 1990, amends section 519 of the FD&C Act. The amendment
requires that user facilities such as hospitals, nursing homes,
ambulatory surgical facilities, and outpatient treatment facilities
report deaths related to medical devices to FDA and to the
manufacturer, if known. Serious illnesses and injuries are to be
reported to the manufacturer or to FDA if the manufacturer is not
known. These statutory requirements regarding mandatory reporting have
been codified by FDA under 21 CFR part 803, which mandates the use of
FDA Form 3500A for reporting to FDA on medical devices. The Medical
Device User Fee and Modernization Act of 2002, Public Law 107-250,
signed into law October 26, 2002, amended section 519 of the FD&C Act.
The amendment (section 303) required FDA to revise the MedWatch forms
``to facilitate the reporting of information * * * relating to
reprocessed single-use devices, including the name of the reprocessor
and whether the device has been reused.''
C. Nonprescription Drug Products and Dietary Supplements
Section 502(x) in the FD&C Act implements the requirements of the
Dietary Supplement and Nonprescription Drug Consumer Protection Act,
which became law (Pub. L. 109-462) on December 22, 2006. These
requirements apply to manufacturers, packers, and distributors of
nonprescription (OTC) human drug products marketed without an approved
application. The law requires reports of serious adverse events to be
submitted to FDA by manufacturers of dietary supplements and
nonprescription drugs.
IV. Proposed Modifications to Existing Forms 3500 and 3500A
A. General Changes
The proposed modifications to FDA Form 3500 and FDA Form 3500A
reflect changes that will bring the form into conformation, since the
previous authorization in 2008, with current regulations, rules, and
guidances.
B. Changes Proposed for FDA Form 3500
No additional fields will be added and no fields deleted. There are
no proposed formatting changes to the location or distribution of the
fields. Modifications are proposed to several field labels and
descriptions to better clarify for reporters the range of reportable
products, including tobacco products and food (e.g., food allergens
causing allergic or anaphylaxis reactions). Descriptive text in the
field labels and instructions were modified to permit a better
understanding of data requested. For section E, field E4, the label
``Other'' will be renamed ``Unique Identifier '' in
anticipation of the use of this product information by the Agency for
specific characterization and identification of the medical device. The
form remains a one-sided, one-page form with instructions for use on
the reverse side and a self-addressed, postage-paid return mailer.
C. Changes Proposed for FDA Form 3500A
Certain formatting changes are proposed to allow mandatory
reporters to better utilize available space for data entry and
facilitate specification of the device product's coding. In section D,
field D2, it is proposed that the same field be used to request the
procode (D2b) to correspond to the existing common device name (D2a).
The D4 field currently named ``Other'' will be renamed ``Unique
Identifier .'' Section H, currently named ``Device
Manufacturers Only'' will be renamed ``Manufacturers Only.'' Field H1
will have the ``Other'' checkbox removed and field H6, renamed ``Event
Problem and Evaluation Codes,'' will have patient code and device code
boxes added, as in the existing form's field F10. In section G, field
G5, STN will be relabeled BLA . Given the need to
contact mandatory reporters in a timely manner, the Agency proposes
that a field be added to FDA Form 3500A to request an email address for
the mandatory reporter, to supplement the phone number and mailing
address currently included on the form. This change is proposed for
fields E1 and G1.
V. Proposed Addition of Consumer Version of FDA Form 3500
FDA supports and encourages direct reporting to the Agency by
consumers (patients and their caregivers) of suspected serious adverse
outcomes and other product problems associated with human medical
products (http://www.fda.gov/Safety/ReportaProblem/default.htm.) Since
the inception of the MedWatch program, launched in July 1993 by then
FDA Commissioner David Kessler, the program has been promoting and
facilitating voluntary reporting by both the general public and health
care professionals (Ref. 1). FDA has further encouraged voluntary
reporting by requiring inclusion of the MedWatch toll-free telephone
number or the MedWatch Internet address on all outpatient drug
prescriptions dispensed, as mandated by section 17 of the Best
Pharmaceuticals for Children Act (Pub. L. 107-109).
On March 25, 2008, section 906 of the FDA Amendments Act amended
section 502(n) of the FD&C Act and mandated that published direct-to-
consumer advertisements for prescription drugs include the following
statement printed in conspicuous text (this includes vaccine products):
``You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-(800)
FDA-1088.'' Most private vendors of consumer medication information,
the drug product-specific instructions dispensed to consumers at
outpatient pharmacies, remind patients to report ``side effects'' to
FDA and provide contact information to permit reporting via the
MedWatch process and FDA Form 3500.
Currently, the non-health care professional public may submit
voluntary reports using FDA Form 3500 (http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm). This reporting form was created 20
years ago and modeled after an earlier version of the Agency's
reporting form for health care professionals. FDA Form 3500 is provided
in paper and electronic formats (HTML version at http://www.fda.gov/medwatch/report.htm and fillable pdf version at http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf), and
is used to report to the Agency about serious adverse events, product
problems, product use errors, and therapeutic failure (therapeutic
inequivalence). Reporting is supported for all FDA-regulated human
medical care products, including drugs, biologicals, medical devices,
special nutritional products, dietary supplements, cosmetics, and
nonprescription (OTC) human drug products marketed without an approved
application.
Qualitative assessment by social scientists, and comments and
feedback from the public, have recognized that FDA Form 3500 is written
and formatted at a literacy/comprehensibility level that far exceeds
[[Page 76420]]
the level recommended for the general public by health literacy experts
and does not conform to recommendations in the Plain Writing Act of
2010 (http://www.gpo.gov/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).
The proposed consumer version of the voluntary FDA Form 3500 will
request no new data from the voluntary reporter not already included in
the existing FDA Form 3500 that is currently used for reporting from
both health care professionals and consumers (patients). Certain
existing fields not considered essential data for the consumer report
but present on the standard (i.e., health care professional) version of
FDA Form 3500 have been eliminated to facilitate and expedite consumer
submissions and reduce reporting burden. The formatting and plain
language used are compatible with the intent of the Plain Writing Act
and is expected to provide non-health care professionals with a second
option to the existing FDA Form 3500 that will reduce the burden of
reporting by facilitating their understanding of the requested data and
further clarify the voluntary reporting process.
The proposed consumer version of FDA Form 3500 evolved from several
iterations of draft versions, with input from human factors experts,
from other regulatory agencies and with extensive input from consumer
advocacy groups and the general public. The Agency recognizes that many
consumer reporters have a preference for accessing a copy of the
voluntary reporting form on the Internet or submitting to FDA using an
electronic version of the form. The Agency currently supports voluntary
reporting with the forms submitted by mail, by FAX, by telephone via
the toll free 800 number and online at http://www.fda.gov/medwatch/report.htm. It is the Agency's expectation that an approved consumer
version of the voluntary form will be provided for consumer use by
these same channels.
In the Federal Register of September 9, 2011 (76 FR 55919), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Comments were received from seven
individuals and organizations.
VI. Response to Comments
1. 3500 Form
(Comment 1) One comment observed that it may be difficult for FDA
to identify the pregnancy status of the person experiencing the
reported adverse event and suggested that the Agency add a separate
field for documenting pregnancy status.
(Response) FDA agrees that documenting pregnancy status is
important; however, FDA does not plan to add an additional checkbox for
pregnancy to the forms at this time. In 2005, FDA proposed adding
checkboxes for both ``Product Used During Pregnancy'' and ``Product
Used During Breast Feeding'' to section B.5 of both forms. FDA received
comments expressing concern that these new data fields introduced
divergence from International Council on Harmonisation standards and
appeared to duplicate information that is usually provided in the
narrative section and in coded adverse event terms. The pregnancy
status data can also be captured in field B7 as ``Other Relevant
History''. FDA agreed with the comments and did not include these
checkboxes with the 2005 revisions; FDA believes these reasons are
still valid.
(Comment 2) One comment encouraged the FDA to use the voluntary
consumer version of the form to allow for electronic filing of reports
and to continue to promote the reporting process to the public, whether
by the traditional paper-based route or electronically.
(Response) FDA agrees with the comment and expects to support both
the promotion of the use of the new consumer version of the voluntary
form and to explore methods of facilitating reporting and reducing
reporter burden by using online and other electronic means of report
submission.
(Comment 3) One comment supported the plan to deploy a consumer
version of the voluntary form and suggested that its use also be
promoted to health care providers for their use. The comment also
encouraged the Agency to expedite a process for converting the paper-
based reporting process to allow for electronic submission of voluntary
reports using the consumer version of the form.
(Response) FDA agrees that support of electronic submissions of
voluntary reports should be supported and facilitated. The new form was
designed as a consumer friendly option for use by non-health care
professionals. The standard FDA Form 3500 will continue to be the
primary form offered to health care professionals. FDA encourages the
continued use of FDA Form 3500 by health care professionals; however,
if a health care professional chooses to submit a report using the
consumer form, it will be accepted by FDA.
(Comment 4) One comment stated that implementing a consumer
friendly version of FDA Form 3500 would not ``serve any value'' and
suggested that instead a more comprehensible form be created that would
be used by health care professionals and consumers.
(Response) The Agency disagrees. The current FDA Form 3500 is
widely known, well accepted, and used by the range of health care
professionals. Assessment of, and feedback from, consumers has
demonstrated the demand and need for a modified form that would serve
those non-health care professional reporters, using both literacy-
appropriate language and formatting that will serve consumers but not
be optimal for health care professional reporting.
(Comment 5) A comment suggested that for the proposed change to
field E4 from ``Other'' to ``Unique Identifier'' that the term used be
``UDI''.
(Response) FDA agrees with this comment.
(Comment 6) One comment supported the development of a consumer
friendly version of the voluntary form but observed that with the
anticipated increase in the number of consumer-initiated reports that
the Agency consider a process for ``broader sharing with industry
sponsors of adverse event reports made directly to FDA.''
(Response) FDA agrees that adverse event report data should be more
readily available to the public (which includes industry). The current
mechanisms that FDA has to share reports with industry are the MedWatch
to Manufacturer Program and through requests to Freedom of Information.
In addition, as part of Phase II of the FDA Transparency Initiative,
FDA is planning to provide the public with online access (in a
searchable format) to public information from adverse event reports
submitted to FDA.
2. 3500A Form
(Comment 7) One comment asked that no changes be made to the FDA
Form 3500A at the present time due to consideration of the costs and
expenditure of resources incurred by mandatory reporters who are often
using electronic systems to do their required reporting to FDA. In
addition, the comment noted that there are several proposed or not yet
finalized rules that might further impact the content of the mandatory
FDA Form 3500. A comment stated that they would ask for a 12-month
implementation time to allow for design, testing, and validation of any
software changes necessary.
(Response) The Agency has considered the impact of implementing
changes to FDA Form 3500A and the need for mandatory reporters to
change their electronic systems to comply with the proposed changes.
FDA will allow
[[Page 76421]]
for sufficient time for design, testing, and validation of any software
changes as a result of any new data requirements that may follow from
new requirements based on final rules and regulations.
(Comment 8) One comment stated that for mandatory reporters the
estimate of burden has been underestimated and fails to take into
consideration the effort by firms to collect facts, prepare
investigations, and evaluate the data.
(Response) The Agency disagrees that the estimate for the average
time to complete a given report is low. This estimate is intended not
to represent the totality of the effort for completing the postmarket
drug and device safety surveillance process mandated by law, rule, and
regulation for application holders but a fair estimate of data
collection, organization, entry, and submission time for a given
``average'' report.
(Comment 9) A comment suggested that for the proposed change to
field D4 from ``Other'' to ``Unique Identifier'' that the term used be
``UDI''.
(Response) FDA agrees with this comment. We recommend changing this
to UDI.
(Comment 10) A comment disagreed with requesting an email address
from the reporter in field E1, and a second comment expressed similar
reservations but suggested that, if used, the initial reporter
understand that this information is optional.
(Response) FDA recognizes that an email address is one of several
elements in the contact information that may assist FDA and others in
effective postmarket safety surveillance and followup inquiries. The
reporter is not compelled to complete the information in this field in
order for the report to be considered complete and registered in the
appropriate database. A statement that this information is optional
will be made clear in the instructions for completing the form.
(Comment 11) A comment disagreed with the proposed change in the
Section H heading from ``Device Manufacturers Only'' to ``Manufacturers
Only''.
(Response) FDA agrees that this title should not be changed.
Section H should be titled ``Device Manufacturers Only'' as it
currently appears.
(Comment 12) Two comments recommended the addition of a new
checkbox field in Section/field H2 named ``Final report'' that would be
used to ``reflect the best efforts of the manufacturer to retrieve and
analyze information pertaining to the reported event''.
(Response) FDA disagrees that ``Final report'' should be added to
Section H2. This information can be added as part of the text narrative
in Section H10.
(Comment 13) Two comments disagreed with the removal of field H1's
``Other'' checkbox and stated that there are rare examples of events
that do not meet the regulatory definition of death, serious injury, or
malfunction but are considered by the mandatory reporting entity to be
necessary and required reports. One comment suggested that if the
checkbox is removed, that specific instruction be provided for handling
reports that would have been compatible with an ``Other'' designation.
(Response) FDA disagrees. FDA recommends removal of the ``Other''
checkbox. In lieu of the checkbox, FDA proposes that rare events that
fit the definition of ``Other significant adverse device experiences''
as specified in FD&C Act section 519(a)(3) can be submitted to the FDA
using the mailing address identified in 21 CFR 803.12(a).
(Comment 14) One comment suggested changing the title of field B4
from ``Date of This Report'' to ``Date of First Contact With Initial
Reporter''.
(Response) FDA disagrees. On August 21, 2009, FDA published a
proposed rule (74 FR 42203) to amend part 803 to require manufacturers,
importers, and user facilities to submit medical device reports to the
Agency in an electronic format (i.e., the 2009 proposed rule). Section
II(4)(D)(2) of the 2009 proposed rule specified that in the final rule,
FDA specifically proposed to change Sec. Sec. 803.32(b)(4),
803.42(b)(4), and 803.52(b)(4) from ``date of report by the initial
reporter'' to ``date of this report''. Further it states, ``This change
would make part 803 consistent with the way that other FDA Centers
interpret FDA Form 3500A, Block B4 and how Block B4 appears on FDA Form
3500A.''
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FDA Center FDA Form (21 CFR Section) Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Center for Biologics Evaluation and Research/
Center for Drug Evaluation and Research:
Form 3500................................. 28,952 1 28,952 0.60............................ 17,371
(36 minutes).................... ................
Form 3500A (Sec. Sec. 310.305, 314.80, 599 96 57,504 1.10............................
314.98, and 600.80).
Center for Devices and Radiological Health:
Form 3500................................. 4,585 1 4,585 0.60............................ 2,751
(36 minutes).................... ................
Form 3500A (Sec. 803)................... 1,485 225 334,125 1.10............................ 367,538
(66 minutes)....................
Center for Food Safety and Applied Nutrition:
Form 3500................................. 297 1 297 0.6............................. 178
(36 minutes)....................
Form 3500A................................ 1,039 1 1,039 1.10............................ 1,143
(66 minutes)....................
Total................................. ................ ................ ................ ................................ 452,234
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 76422]]
VII. Reference
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Kessler, D.A., ``Introducing MEDWatch: A New Approach to
Reporting Medication and Device Adverse Effects and Product
Problems,'' Journal of the American Medical Association, 269: 2765-
2768, 1993.
Dated: December 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31341 Filed 12-6-11; 8:45 am]
BILLING CODE 4160-01-P