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Federal Register / Vol. 73, No.

32 / Friday, February 15, 2008 / Notices 8879

contract requirements. CMS will use DEPARTMENT OF HEALTH AND agencies must obtain approval from the
this information to approve contract HUMAN SERVICES Office of Management and Budget
applications, monitor compliance with (OMB) for each collection of
contract requirements, make proper Food and Drug Administration information they conduct or sponsor.
payment to MA organizations, [Docket No. FDA–2008–N–0077] ‘‘Collection of information’’ is defined
determine compliance with the new in 44 U.S.C. 3502(3) and 5 CFR
prescription drug benefit requirements Agency Information Collection 1320.3(c) and includes agency requests
established by the MMA, and to ensure Activities; Proposed Collection; or requirements that members of the
that correct information is disclosed to Comment Request; MedWatch: The public submit reports, keep records, or
Food and Drug Administration Medical provide information to a third party.
Medicare beneficiaries, both potential
Products Reporting Program Section 3506(c)(2)(A) of the PRA (44
enrollees and enrollees. Form Number:
U.S.C. 3506(c)(2)(A)) requires Federal
CMS–R–267 (OMB #0938–0753); AGENCY: Food and Drug Administration, agencies to provide a 60-day notice in
Frequency: Yearly; Affected Public: HHS. the Federal Register concerning each
Business or other for-profit, and ACTION: Notice. proposed collection of information,
individuals or households; Number of including each proposed extension of an
Respondents: 9,000,670; Total Annual SUMMARY: The Food and Drug
existing collection of information,
Responses: 9,000,670; Total Annual Administration (FDA) is announcing an before submitting the collection to OMB
Hours: 7,711,085. opportunity for public comment on the for approval. To comply with this
proposed collection of certain requirement, FDA is publishing notice
To obtain copies of the supporting
information by the agency. Under the of the proposed collection of
statement and any related forms for the Paperwork Reduction Act of 1995 (the
proposed paperwork collections information set forth in this document.
PRA), Federal agencies are required to With respect to the following
referenced above, access CMS’ Web site publish notice in the Federal Register collection of information, FDA invites
address at http://www.cms.hhs.gov/ concerning each proposed collection of comments on these topics: (1) Whether
PaperworkReductionActof1995, or E- information, including each proposed the proposed collection of information
mail your request, including your extension of an existing collection of is necessary for the proper performance
address, phone number, OMB number, information, and to allow 60 days for of FDA’s functions, including whether
and CMS document identifier, to public comment in response to the the information will have practical
Paperwork@cms.hhs.gov, or call the notice. This notice solicits comments on utility; (2) the accuracy of FDA’s
Reports Clearance Office on (410) 786– the present MedWatch Forms 3500 and estimate of the burden of the proposed
1326. 3500A (also known as MedWatch collection of information, including the
In commenting on the proposed reporting forms) having an OMB validity of the methodology and
information collections please reference expiration date of October 31, 2008. assumptions used; (3) ways to enhance
the document identifier or OMB control These forms are presently used to report the quality, utility, and clarity of the
number. To be assured consideration, to the agency about adverse events, information to be collected; and (4)
product problems, and medication/ ways to minimize the burden of the
comments and recommendations must
device use errors that occur with FDA collection of information on
be submitted in one of the following
regulated products, including drugs, respondents, including through the use
ways by April 15, 2008:
biologicals, medical devices, special of automated collection techniques,
1. Electronically. You may submit nutritional products, dietary when appropriate, and other forms of
your comments electronically to http:// supplements, and non-prescription information technology.
www.regulations.gov. Follow the (over-the-counter (OTC)) human drug
instructions for ‘‘Comment or MedWatch: The FDA Medical Products
products marketed without an approved
Reporting Program, Form FDA 3500
Submission’’ or ‘‘More Search Options’’ application.
and Form FDA 3500A—(OMB Control
to find the information collection DATES: Submit written or electronic
Number 0910–0291)—Extension
document(s) accepting comments. comments on the collection of
information by April 15, 2008. Under sections 505, 512, 513, 515,
2. By regular mail. You may mail and 903 of the Federal Food, Drug, and
written comments to the following ADDRESSES: Submit electronic
comments on the collection of Cosmetic Act (the act) (21 U.S.C. 355,
address: CMS, Office of Strategic 360b, 360c, 360e, and 393), and section
Operations and Regulatory Affairs, information to http://
www.regulations.gov. Submit written 351 of the Public Health Service Act (42
Division of Regulations Development, U.S.C. 262), FDA has the responsibility
Attention: Document Identifier/OMB comments on the collection of
information to the Division of Dockets to ensure the safety and effectiveness of
Control Number ll, Room C4–26–05, drugs, biologics, and devices. Under
7500 Security Boulevard, Baltimore, Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm. section 502(a) of the act (21 U.S.C.
Maryland 21244–1850. 352(a)), a drug or device is misbranded
1061, Rockville, MD 20852. All
Dated: February 8, 2008. comments should be identified with the if its labeling is false or misleading.
docket number found in brackets in the Under section 502(f)(1) of the act it is
Michelle Shortt,
heading of this document. misbranded if it fails to bear adequate
Director, Regulations Development Group, warnings, and under section 502(j), it is
Office of Strategic Operations and Regulatory FOR FURTHER INFORMATION CONTACT:
misbranded if it is dangerous to health
Affairs. Elizabeth Berbakos, Office of the Chief when used as directed in its labeling.
[FR Doc. E8–2813 Filed 2–14–08; 8:45 am] Information Officer (HFA–250), Food Under section 4 of the Dietary
rwilkins on PROD1PC63 with NOTICES

BILLING CODE 4120–01–P and Drug Administration, 5600 Fishers Supplement Health and Education Act
Lane, Rockville, MD 20857, 301–827– of 1994 (Public Law 103–417), 21 U.S.C.
1482. 342 is amended so that FDA must bear
SUPPLEMENTARY INFORMATION: Under the the burden of proof to show a dietary
PRA (44 U.S.C. 3501–3520), Federal supplement is unsafe.

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8880 Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices

To carry out its responsibilities, the Vaccine Injury Act of 1986 (Public Law adulterated or misbranded and to
agency needs to be informed whenever 99–660). Those mandatory reports are otherwise assure their safety and
an adverse event, product problem, or not submitted to FDA on the 3500 or effectiveness. The Safe Medical Device
error with use of a medication or device 3500A forms, but are submitted to the Act of 1990 (Public Law 91–4243),
occurs. Only if FDA is provided with joint FDA/Centers for Disease Control signed into law on November 28, 1990,
such information will the agency be able and Prevention Vaccines Adverse Event amends section 519 of the act. The
to evaluate the risk, if any, associated Reporting System (VAERS) on the amendment requires that user facilities
with the product, and take whatever VAERS–1 form (see: http:// such as hospitals, nursing homes,
action is necessary to reduce or www.vaers.hhs.gov/pdf/vaers_form.pdf). ambulatory surgical facilities, and
eliminate the public’s exposure to the Hospitals are not required by Federal outpatient treatment facilities report
risk through regulatory action. To law or regulation to submit reports deaths related to medical devices to
ensure the marketing of safe and associated with drug products, FDA and to the manufacturer, if known.
effective products, certain adverse biological products, or special Serious illnesses and injuries are to be
events must be reported. Requirements nutritional products. However, hospitals reported to the manufacturer or to FDA
regarding mandatory reporting of and other user facilities are required by if the manufacturer is not known. These
adverse events or product problems Federal law to report medical device- statutory requirements regarding
have been codified in parts 310, 314, related deaths and serious injuries. mandatory reporting have been codified
600, and 803 (21 CFR 310, 314, 600, and II. Use of Form FDA 3500A (Mandatory by FDA under part 803. Part 803
803), specifically §§ 310.305, 314.80, Version) mandates the use of FDA Form 3500A
314.98, 600.80, 803.30, 803.50, 803.53, for reporting to FDA on medical
and 803.56. A. Drug and Biologic Products devices.
Two forms are available from the In sections 505(j) and 704 of the act The Medical Device User Fee and
agency in order to implement these (21 U.S.C. 374), Congress has required Modernization Act of 2002 (MDUFMA)
provisions for reporting of adverse that important safety information (Public Law 107–250), signed into law
events, product problems, and relating to all human prescription drug October 26, 2002, amended section 519
medication/device use errors for FDA products be made available to FDA so of the act. The amendment (section 303
regulated products such as medications, that it can take appropriate action to of MDUFMA) required FDA to revise
devices, biologics, special nutritional protect the public health when the MedWatch forms ‘‘to facilitate the
products, cosmetics, dietary necessary. Section 702 of the act (21 reporting of information * * *relating
supplements, and non-prescription U.S.C. 372) authorizes investigational to reprocessed single-use devices,
(OTC) human drug products marketed powers to FDA for enforcement of the including the name of the reprocessor
without an approved application, as act. These statutory requirements and whether the device has been
well as any other products that are regarding mandatory reporting have reused.’’
regulated by FDA. Form FDA 3500 may been codified by FDA under parts 310 Under section 303 of the FDA
be used by health care professionals and and 314 (drugs) and 600 (biologics). Amendments Act of 2007 (Public Law
the public for voluntary (i.e., not Parts 310, 314, and 600 mandate the use 110–85), FDA must share reports for
mandated by law or regulation) of FDA Form 3500A for reporting to Humanitarian Device Exemption (HDE)
reporting. Form FDA 3500A is used by FDA on adverse events that occur with devices. To facilitate sharing the
industry for mandatory reporting (i.e., drugs and biologics. appropriate reports, it would be helpful
required by law or regulation). Manufacturers whose name (under to obtain the HDE number in the present
Respondents to this collection of section 403(e)(1) of the act (21 U.S.C. section G, box 5, on page 2 of FDA Form
information are health care 343(e)(1)) appears on the label of a 3500A.
professionals, hospitals and other user- dietary supplement marketed in the III. Proposed Modifications to Forms
facilities (e.g., nursing homes, etc.), United States are required to report
consumers, manufacturers of biological adverse reactions associated with use of The proposed extension to Form FDA
and drug products or medical devices, the dietary supplement to FDA (the 3500 and Form FDA 3500A will only
and importers. Dietary Supplement and have changes in the form instructions to
Nonprescription Drug Consumer reflect the range of reportable products
I. Use of Form FDA 3500 (Voluntary and provide clarity of reporting. The
Version) Protection Act (Public Law 109–462)).
previous forms changes (2005–2008)
The voluntary version of the form is B. Medical Device Products allow reporters to better utilize available
used to submit all reports not mandated Section 519 of the act (21 U.S.C. 360i) space for data entry and offer voluntary
by Federal law or regulation. Individual requires manufacturers and importers of reporters the opportunity to clearly
health professionals are not required by devices intended for human use to describe the suspected adverse event,
law or regulation to submit reports to establish and maintain records, make product problem or error, and provide
the agency or the manufacturer, with the reports, and provide information as the better quality safety-related data for
exception of certain adverse reactions Secretary of Health and Human Services agency evaluation.
following immunization with vaccines may by regulation reasonably require to FDA estimates the burden of this
as mandated by the National Childhood assure that such devices are not collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
FDA Center Total Hours
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Respondents per Response Responses Response

CBER/CDER

Form 3500 22,955 1 22,955 0.6 13,773

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Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices 8881

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued


No. of Annual Frequency Total Annual Hours per
FDA Center Total Hours
Respondents per Response Responses Response

Form 3500A (§§ 310.305,


314.80, 314.98, and
600.80) 600 579.9 347,940 1.1 382,734

CDRH

Form 3500 3,433 1 3,433 0.6 2,060


Form 3500A (Part 803) 1,935 33 63,855 1.0 63,855

CFSAN

Form 3500 847 1 847 0.6 508


Form 3500A 0 0 0 1.0 0

Form 3500 16,341


Form 3500A 446,589
Total 462,930
1CBER (Center for Biologics Evaluation and Research), CDER (Center for Drug Evaluation and Research), CDRH (Center for Devices and Ra-
diological Health), and CFSAN (Center for Food Safety and Applied Nutrition). FDA Form 3500 is for voluntary reporting; FDA Form 3500A is for
mandatory reporting.

Please note that on January 15, 2008, public comment in response to the agencies to provide a 60-day notice in
the FDA Web site transitioned to the notice. This notice solicits comments on the Federal Register concerning each
Federal Dockets Management System the information collection requirements proposed collection of information,
(FDMS). FDMS is a Government-wide, relating to FDA’s adverse experience including each proposed extension of an
electronic docket management system. reporting (AER) for licensed biological existing collection of information,
Electronic submissions will be accepted products, and general records associated before submitting the collection to OMB
by FDA through FDMS only. with the manufacture and distribution for approval. To comply with this
Dated: February 8, 2008. of biological products. requirement, FDA is publishing notice
Jeffrey Shuren, DATES: Submit written or electronic of the proposed collection of
comments on the collection of information set forth in this document.
Assistant Commissioner for Policy.
information by April 15, 2008. With respect to the following
[FR Doc. E8–2821 Filed 2–14–08; 8:45 am] collection of information, FDA invites
BILLING CODE 4160–01–S
ADDRESSES: Submit electronic
comments on the collection of comments on these topics: (1) Whether
information to http:// the proposed collection of information
www.regulations.gov. Submit written is necessary for the proper performance
DEPARTMENT OF HEALTH AND of FDA’s functions, including whether
HUMAN SERVICES comments on the collection of
information to the Division of Dockets the information will have practical
Food and Drug Administration Management (HFA–305), Food and Drug utility; (2) the accuracy of FDA’s
Administration, 5630 Fishers Lane, rm. estimate of the burden of the proposed
[Docket No. FDA–2008–N–0073] (formerly collection of information, including the
Docket No. 2002N–0418) 1061, Rockville, MD 20852. All
comments should be identified with the validity of the methodology and
docket number found in brackets in the assumptions used; (3) ways to enhance
Agency Information Collection
heading of this document. the quality, utility, and clarity of the
Activities: Proposed Collection;
information to be collected; and (4)
Comment Request; Adverse FOR FURTHER INFORMATION CONTACT:
ways to minimize the burden of the
Experience Reporting for Licensed JonnaLynn P. Capezzuto, Office of the collection of information on
Biological Products; and General Chief Information Officer (HFA–250), respondents, including through the use
Records Food and Drug Administration, 5600 of automated collection techniques
AGENCY: Food and Drug Administration, Fishers Lane, Rockville, MD 20857, when appropriate, and other forms of
HHS. 301–827–4659. information technology.
ACTION: Notice. SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal Adverse Experience Reporting for
SUMMARY: The Food and Drug agencies must obtain approval from the Licensed Biological Products; and
Administration (FDA) is announcing an Office of Management and Budget General Records —21 CFR Part 600
opportunity for public comment on the (OMB) for each collection of (OMB Control Number 0910–0308)—
proposed collection of certain information they conduct or sponsor. Extension
information by the agency. Under the ‘‘Collection of information’’ is defined Under the Public Health Service Act
Paperwork Reduction Act of 1995 (the in 44 U.S.C. 3502(3) and 5 CFR (42 U.S.C. 262), FDA is required to
PRA), Federal agencies are required to 1320.3(c) and includes agency requests ensure the marketing of only those
rwilkins on PROD1PC63 with NOTICES

publish notice in the Federal Register or requirements that members of the biological products which are safe and
concerning each proposed collection of public submit reports, keep records, or effective. FDA must, therefore, be
information, including each proposed provide information to a third party. informed of all adverse experiences
extension of an existing collection of Section 3506(c)(2)(A) of the PRA (44 occasioned by the use of licensed
information, and to allow 60 days for U.S.C. 3506(c)(2)(A)) requires Federal biological products. FDA issued the

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