
[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76417-76422]
From the Federal Register Online via the Government Printing 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 oira_submission@omb.eop.gov. 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, Jonnalynn.Capezzuto@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.

[[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
     FDA Center FDA Form (21 CFR Section)           Number of       responses per     Total annual      Average burden per  response       Total hours
                                                   respondents       respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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


