83 FR 11756 - Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 52 (March 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 52 (March 16, 2018)
| Page Range | 11756-11759 | |
| FR Document | 2018-05337 |
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)] [Notices] [Pages 11756-11759] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05337] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1960] Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on revisions to Forms FDA 3500, 3500A, and 3500B used in the FDA Medical Products Reporting Program. DATES: Submit either electronic or written comments on the collection of information by May 15, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-N-1960 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The FDA Medical Products Reporting Program.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three [[Page 11757]] White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. MedWatch: The FDA Medical Products Reporting Program--OMB Control Number 0910-0291--Extension Members of the public use FDA's MedWatch system to report adverse events, product problems, errors with the use of a human medical product, or when evidence of therapeutic failure is suspected or identified in clinical use. To ensure the marketing of safe and effective products, it is critical that postmarketing adverse outcomes and product problems are reported for all FDA-regulated human healthcare products, including drugs (prescription and nonprescription), biologics, medical devices, dietary supplements, and other special nutritional products (e.g. infant formula and medical foods), and cosmetics. To facilitate reporting on human medical products (except vaccines) during their postapproval and marketed lifetimes, three forms (collectively known as the MedWatch forms) are available from the Agency. Form FDA 3500 is intended to be used for voluntary (i.e., not mandated by law or regulation) reporting by healthcare professionals. Form FDA 3500B is written in plain language and is intended to be used for voluntary reporting (i.e., not mandated by law or regulation) by consumers (i.e., patients and their caregivers). Form FDA 3500A is used for mandatory reporting (i.e., required by law or regulation). When FDA receives this information from healthcare professionals, patients, or consumers, the report becomes data that will be used to assess and evaluate the risk associated with the product. FDA will then take whatever action is necessary to reduce, mitigate, or eliminate the public's exposure to the risk through regulatory and public health interventions. Authorizing Statutes and Codified Regulations The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b, 355, 360i, 360l, and 393); and the Public Health Service Act (42 U.S.C. 262) represent the statutory authority for the FDA to collect mandatory adverse event reports from regulated industry on medical products once approved for marketing--to monitor the safety of drugs, biologics, medical devices, and dietary supplements. There are no laws or regulations mandating the post-market reporting for medical foods, infant formula, cosmetics, or tobacco products, and the reporting for these products is done voluntarily. 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 503B, 760, and 761 of the FD&C Act (21 U.S.C. 353b, 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. Use of Form 3500 (Voluntary Reporting) This voluntary version of the form may be used by healthcare professionals 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 Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Reports for vaccines are not submitted via MedWatch or MedWatch forms, but are submitted to the Vaccines Adverse Event Reporting System (see https://vaers.hhs.gov), which is jointly administered by FDA and the Centers for Disease Control and Prevention. 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 (21 U.S.C. 342) 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. All dietary supplement reports were previously received by the Agency on paper versions of Form FDA 3500 (or Form FDA 3500B) (by mail or fax). Currently, electronic reports may be sent to the Agency via an online submission route called the Safety Reporting Portal (https://www.safetyreporting.hhs.gov/). In that case, Form FDA 3500 (or Form FDA 3500B) is not used. Form FDA 3500 may be used to report to the Agency serious adverse events, product problems, and product use errors and therapeutic failures. The form is provided in both paper and electronic formats. Reporters may mail or fax paper forms to the Agency (a fillable PDF version of the form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) or reporters may electronically submit a report via the MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/). Reporting is supported for drugs, non-vaccine biologicals, medical devices, special nutritional products, cosmetics, and non-prescription (over the counter (OTC)) human drug products marketed without an approved [[Page 11758]] application. The paper form may also be used to submit reports about tobacco products and dietary supplements. Electronic reports for tobacco products and dietary supplements may be submitted to the Agency via an online submission route called the Safety Reporting Portal (https://www.safetyreporting.hhs.gov/). Use of Form 3500B (Consumer Voluntary Reporting) This voluntary version of the form may be used by consumers (i.e. patients and their caregivers) to submit reports not mandated by Federal law or regulation. Individual patients or their caregivers are not required by law or regulation to submit reports to the Agency or the manufacturer. FDA supports and encourages direct reporting to the Agency by consumers of suspected serious adverse outcomes and other product problems associated with human medical products, (https://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 healthcare professionals. FDA has further encouraged voluntary reporting by requiring inclusion of the MedWatch toll-free phone 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 Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) amended section 502(n) of the FD&C Act (21 U.S.C. 352) 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 https://www.fda.gov/safety/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. Since 2013, FDA has made available Form FDA 3500B. It was proposed during the previous authorization in 2012 and is a version of Form FDA 3500 that is tailored for consumers and written in plain language (in conformance with the Plain Writing Act of 2010 (Pub. L. 111-274), https://www.thefederalregister.org/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf). Form FDA 3500B 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. Form FDA 3500B may be used to report to the Agency adverse events, product problems, and product use errors. The form is provided in both paper and electronic formats. Reporters may mail or fax paper forms to the Agency (a fillable PDF version of the form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf) or electronically submit a report via the MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/). Reporting is supported for drugs, non-vaccine biologicals, medical devices, special nutritional products, cosmetics, and non-prescription OTC human drug products marketed without an approved application. The paper form may also be used to submit reports about tobacco products and dietary supplements. Electronic reports for tobacco products and dietary supplements may be submitted to the Agency via an online submission route called the Safety Reporting Portal (https://www.safetyreporting.hhs.gov/). I. Use of Form FDA 3500A (Mandatory Version) A. Drug and Biological Products In sections 505(b) and (j), 503B, and 704 (21 U.S.C. 355(b) and (j), 353B, and 374) of the FD&C Act, Congress has required that important safety information relating to all human 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 the FDA for enforcement of the FD&C Act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 and 314 (drugs) and 600 (biological products). Mandatory reporting of adverse reactions for HCT/Ps has been codified in Sec. 1271.350. B. OTC Monograph Drug Products and Dietary Supplements Section 760 of the FD&C Act provides for mandatory safety reporting for non-prescription human drug products marketed without an approved application as described in the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, December 22, 2006), which became law on December 22, 2006. The law requires manufacturers, packers, and distributors of nonprescription, over-the-counter (OTC) human drug products marketed without an approved application (OTC monograph drug products) to submit reports of adverse experiences from domestic sources. The law also requires reports of serious adverse events to be submitted to FDA by manufacturers of dietary supplements. C. Postmarketing Safety Reports--Changes in Format Starting in June 2018 Current requirements specify that postmarketing adverse experience reports must be submitted on paper on Form FDA Form 3500A (or the CIOMS (Council for International Organizations of Medical Sciences) I form for serious, unexpected adverse experiences from a foreign source). For the last several years the Agency has accepted electronic submissions in lieu of the paper Form FDA 3500A on the condition they are submitted in a manner that the Agency can process, review, and archive. On June 10, 2014, the Agency issued a final rule entitled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements'' (79 FR 33072) that requires electronic submission of all mandatory postmarketing safety reports, including individual case safety reports. Entities with mandatory reporting obligations under parts 310 and 314 (drugs) and 600 (biological products) and specified under section 760 of the FD&C Act must implement this rule within 1 year of the issuance date (by June 10, 2015). For more information see: https://www.thefederalregister.org/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf. D. Medical Device Products Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers and importers of devices 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 be required to provide assurance that such devices are not adulterated or misbranded and to otherwise assure its safety and effectiveness. The Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on November 28, 1990, amends section 519 of the FD&C Act. The [[Page 11759]] 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 (part 803). Part 803 mandates the use of Form FDA 3500A for reporting to FDA on medical devices. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), signed into law October 26, 2002, amended section 519 of the FD&C Act. The MDUFMA 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. II. Proposed Modification to Existing Forms FDA 3500, 3500A, and 3500B General changes--The proposed modifications to Forms FDA 3500 and 3500A reflect changes that will bring the form into conformance, since the previous authorization in 2015, with current regulations, rules, and guidances. The proposed extension to Forms FDA 3500, 3500A, and 3500B will only have changes in the form instructions to provide clarity of reporting. The proposed changes are regulatory driven, improving the Centers' work, and improving report processing. The Agency welcomes comments about translation of Form FDA 3500B (consumer) into Spanish and other languages. Formatting modifications are being proposed to several fields to enhance the quality, utility, and clarity of the information. 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.................................. 14,727 1 14,727 0.66 (40 min).......................... 9,720 Form 3500A (Sec. Sec. 310.305, 314.80, 599 98 58,702 1.21................................... 71,029 314.98, 600.80, 1271.350). Form 3500A (Sec. Sec. 310.305 50 2 100 1.21................................... 121 outsourcing facilities). Center for Devices and Radiological Health: Form 3500.................................. 5,233 1 5,233 0.66 (40 min).......................... 3,454 Form 3500A (803)........................... 2,277 296 673,992 1.21................................... 815,530 Center for Food Safety and Applied Nutrition: Form 3500.................................. 1,793 1 1,793 0.66 (40 min).......................... 1,183 Form 3500A................................. 1,659 1 1,659 1.21................................... 2,007 Center for Tobacco Products: Form 3500.................................. 39 1 39 0.66 (40 min).......................... 26 All Centers: Form 3500B................................. 13,750 1 13,750 0.46 (28 min).......................... 6,325 -------------------------------------------------------------------------------------------------------- Total.................................. .............. .............. .............. ....................................... 909,395 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates have not changed from the current approval. Dated: March 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-05337 Filed 3-15-18; 8:45 am] BILLING CODE 4164-01-P
![11756 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
FDA is revising the first paragraph of solicits comments on revisions to Forms identified, as confidential, if submitted
the agenda for that meeting to read as FDA 3500, 3500A, and 3500B used in as detailed in ‘‘Instructions.’’
follows: the FDA Medical Products Reporting Instructions: All submissions received
On Thursday, March 22, 2018, the Program. must include the Docket No. FDA–
PAC and EMDAC will meet to discuss DATES: Submit either electronic or 2014–N–1960 for ‘‘Agency Information
drug development for the treatment of written comments on the collection of Collection Activities; Proposed
children with achondroplasia (ACH). information by May 15, 2018. Collection; Comment Request;
The following topics should be MedWatch: The FDA Medical Products
ADDRESSES: You may submit comments
considered for discussion: Evidence Reporting Program.’’ Received
as follows. Please note that late,
required to establish dose-response, comments, those filed in a timely
untimely filed comments will not be
study design, study duration, intended manner (see ADDRESSES), will be placed
considered. Electronic comments must
population, and endpoints. In the open in the docket and, except for those
be submitted on or before May 15, 2018.
session, the committee does not intend submitted as ‘‘Confidential
The https://www.regulations.gov
to discuss any individual research Submissions,’’ publicly viewable at
electronic filing system will accept
programs. https://www.regulations.gov or at the
comments until midnight Eastern Time
FDA is also changing the meeting Dockets Management Staff between 9
at the end of May 15, 2018. Comments
procedure and closed committee a.m. and 4 p.m., Monday through
received by mail/hand delivery/courier
deliberations as follows: Friday.
(for written/paper submissions) will be
Procedure: On March 22, 2018, from • Confidential Submissions—To
considered timely if they are
12 p.m. to 6 p.m., the meeting is open submit a comment with confidential
postmarked or the delivery service
to the public. information that you do not wish to be
acceptance receipt is on or before that
Closed Committee Deliberations: On made publicly available, submit your
date.
March 22, 2018, from 8 a.m. to 11 a.m., comments only as a written/paper
the meeting will be closed to permit Electronic Submissions submission. You should submit two
committee review and discussion of Submit electronic comments in the copies total. One copy will include the
trade secret and/or confidential following way: information you claim to be confidential
commercial information. • Federal eRulemaking Portal: with a heading or cover note that states
This notice is issued under the https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Federal Advisory Committee Act (5 instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
U.S.C. app. 2) and 21 CFR part 14, Comments submitted electronically, Agency will review this copy, including
relating to the advisory committees. including attachments, to https:// the claimed confidential information, in
Dated: March 13, 2018. www.regulations.gov will be posted to its consideration of comments. The
Leslie Kux, the docket unchanged. Because your second copy, which will have the
comment will be made public, you are claimed confidential information
Associate Commissioner for Policy.
solely responsible for ensuring that your redacted/blacked out, will be available
[FR Doc. 2018–05413 Filed 3–15–18; 8:45 am]
comment does not include any for public viewing and posted on
BILLING CODE 4164–01–P https://www.regulations.gov. Submit
confidential information that you or a
third party may not wish to be posted, both copies to the Dockets Management
such as medical information, your or Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND
anyone else’s Social Security number, or contact information to be made publicly
HUMAN SERVICES
confidential business information, such available, you can provide this
Food and Drug Administration as a manufacturing process. Please note information on the cover sheet and not
that if you include your name, contact in the body of your comments and you
[Docket No. FDA–2014–N–1960] must identify this information as
information, or other information that
identifies you in the body of your ‘‘confidential.’’ Any information marked
Agency Information Collection as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; comments, that information will be
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Comment Request; MedWatch: The and other applicable disclosure law. For
Food and Drug Administration Medical • If you want to submit a comment
with confidential information that you more information about FDA’s posting
Products Reporting Program of comments to public dockets, see 80
do not wish to be made available to the
AGENCY: Food and Drug Administration, public, submit the comment as a FR 56469, September 18, 2015, or access
HHS. written/paper submission and in the the information at: https://www.gpo.gov/
manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
ACTION: Notice.
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
SUMMARY: The Food and Drug Docket: For access to the docket to
Administration (FDA or Agency) is Written/Paper Submissions read background documents or the
announcing an opportunity for public Submit written/paper submissions as electronic and written/paper comments
comment on the proposed collection of follows: received, go to https://
certain information by the Agency. • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Under the Paperwork Reduction Act of written/paper submissions): Dockets docket number, found in brackets in the
1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and heading of this document, into the
daltland on DSKBBV9HB2PROD with NOTICES
required to publish notice in the Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
proposed collection of information, • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
including each proposed extension of an submitted to the Dockets Management Rockville, MD 20852.
existing collection of information, and Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
to allow 60 days for public comment in well as any attachments, except for Amber Sanford, Office of Operations,
response to the notice. This notice information submitted, marked and Food and Drug Administration, Three
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![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11759
amendment requires that user facilities section 519 of the FD&C Act. The The proposed extension to Forms
such as hospitals, nursing homes, MDUFMA amendment (section 303) FDA 3500, 3500A, and 3500B will only
ambulatory surgical facilities, and required FDA to revise the MedWatch have changes in the form instructions to
outpatient treatment facilities report forms to facilitate the reporting of provide clarity of reporting. The
deaths related to medical devices to information relating to reprocessed proposed changes are regulatory driven,
FDA and to the manufacturer, if known. single-use devices, including the name improving the Centers’ work, and
Serious illnesses and injuries are to be of the reprocessor and whether the improving report processing. The
reported to the manufacturer or to FDA device has been reused. Agency welcomes comments about
if the manufacturer is not known. These translation of Form FDA 3500B
statutory requirements regarding II. Proposed Modification to Existing
Forms FDA 3500, 3500A, and 3500B (consumer) into Spanish and other
mandatory reporting have been codified languages.
by FDA under 21 CFR part 803 (part General changes—The proposed
803). Part 803 mandates the use of Form modifications to Forms FDA 3500 and Formatting modifications are being
FDA 3500A for reporting to FDA on 3500A reflect changes that will bring the proposed to several fields to enhance
medical devices. The Medical Device form into conformance, since the the quality, utility, and clarity of the
User Fee and Modernization Act of 2002 previous authorization in 2015, with information.
(MDUFMA) (Pub. L. 107–250), signed current regulations, rules, and FDA estimates the burden of this
into law October 26, 2002, amended guidances. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
FDA Center/FDA Form/21 CFR section responses per Total hours
respondents responses per response
respondent
Center for Biologics Evaluation and Research/Center for
Drug Evaluation and Research:
Form 3500 ................................................................. 14,727 1 14,727 0.66 (40 min) .... 9,720
Form 3500A (§§ 310.305, 314.80, 314.98, 600.80, 599 98 58,702 1.21 .................. 71,029
1271.350).
Form 3500A (§§ 310.305 outsourcing facilities) ........ 50 2 100 1.21 .................. 121
Center for Devices and Radiological Health:
Form 3500 ................................................................. 5,233 1 5,233 0.66 (40 min) .... 3,454
Form 3500A (803) ..................................................... 2,277 296 673,992 1.21 .................. 815,530
Center for Food Safety and Applied Nutrition:
Form 3500 ................................................................. 1,793 1 1,793 0.66 (40 min) .... 1,183
Form 3500A ............................................................... 1,659 1 1,659 1.21 .................. 2,007
Center for Tobacco Products:
Form 3500 ................................................................. 39 1 39 0.66 (40 min) .... 26
All Centers:
Form 3500B ............................................................... 13,750 1 13,750 0.46 (28 min) .... 6,325
Total .................................................................... ........................ ........................ ........................ ........................... 909,395
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates have not SUMMARY: The Food and Drug FDA is establishing a docket for
changed from the current approval. Administration (FDA) announces a public comment on this meeting. The
Dated: March 12, 2018. forthcoming public advisory committee docket number is FDA–2018–N–0976.
Leslie Kux,
meeting of the Arthritis Advisory The docket will close on April 20, 2018.
Committee. The general function of the Submit either electronic or written
Associate Commissioner for Policy.
committee is to provide advice and comments on this public meeting by
[FR Doc. 2018–05337 Filed 3–15–18; 8:45 am] April 20, 2018. Please note that late,
recommendations to FDA on regulatory
BILLING CODE 4164–01–P issues. The meeting will be open to the untimely filed comments will not be
public. FDA is establishing a docket for considered. Electronic comments must
public comment on this document. be submitted on or before April 20,
DEPARTMENT OF HEALTH AND 2018. The https://www.regulations.gov
HUMAN SERVICES DATES: The meeting will be held on
electronic filing system will accept
April 23, 2018, from 8 a.m. to 5 p.m.
Food and Drug Administration comments until midnight Eastern Time
ADDRESSES: FDA White Oak Campus, at the end of April 20, 2018. Comments
10903 New Hampshire Ave., Building received by mail/hand delivery/courier
[Docket No. FDA–2018–N–0976] 31 Conference Center, the Great Room (for written/paper submissions) will be
(Rm. 1503), Silver Spring, MD 20993– considered timely if they are
Arthritis Advisory Committee; Notice 0002. Answers to commonly asked postmarked or the delivery service
daltland on DSKBBV9HB2PROD with NOTICES
of Meeting; Establishment of a Public questions including information acceptance receipt is on or before that
Docket; Request for Comments regarding special accommodations due date.
AGENCY: Food and Drug Administration, to a disability, visitor parking, and Comments received on or before April
HHS. transportation may be accessed at: 9, 2018, will be provided to the
https://www.fda.gov/ committee. Comments received after
ACTION: Notice, establishment of a
AdvisoryCommittees/AboutAdvisory that date will be taken into
public docket; request for comments.
Committees/ucm408555.htm. consideration by FDA.
VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1](https://thefederalregister.org/doc/83_FR_11808/page/4.svg)
Document Created: 2018-03-16 01:12:03
Document Modified: 2018-03-16 01:12:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by May 15, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 11756 |
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