Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program, 31042-31048 [2015-13102]

Download as PDF 31042 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices representative from the government of Canada, one representative from the industry of Canada, one representative from the government of South Africa, and one representative from the industry of South Africa. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings. II. Draft Guidance on Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish an Acute Reference Dose (ARfD) The VICH Steering Committee held a meeting in February 2015 and agreed that the draft guidance document entitled ‘‘Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)’’ (VICH GL54) should be made available for public comment. This draft VICH guidance document is intended to address the nature and types of data that can be useful in determining an ARfD for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. III. Significance of Guidance This draft guidance, developed under the VICH process, has been revised to conform to FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD). It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. Lhorne on DSK2VPTVN1PROD with NOTICES IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Action of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. VI. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: May 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–13105 Filed 5–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1960] 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. 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 July 1, 2015. 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 SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ 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. FOR FURTHER INFORMATION CONTACT: MedWatch: The FDA Medical Products Reporting Program OMB Control Number 0910–0291—Extension I. Background 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 (the 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 E:\FR\FM\01JNN1.SGM 01JNN1 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices Lhorne on DSK2VPTVN1PROD with NOTICES supplements. There are no laws or regulations mandating the postmarket 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 §§ 310.305, 314.80, 314.98, 600.80, 803.30, 803.50, 803.53, 803.56, and specified in sections 503B, 760, and 761 (21 U.S.C. 379aa and 379aa–1) of the FD&C Act. 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. II. 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 certain adverse reactions following immunization with vaccines as mandated by the National 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 devicerelated 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 VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 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 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/). III. 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 31043 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 (Pub. L. 110–85) amended section 502(n) of the FD&C Act and mandated that published directto-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 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.gpo.gov/fdsys/pkg/PLAW111publ274/pdf/PLAW111publ274.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 E:\FR\FM\01JNN1.SGM 01JNN1 31044 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices Safety Reporting Portal (https:// www.safetyreporting.hhs.gov/). IV. Use of Form FDA 3500A (Mandatory Version) A. Drug and Biological Products In sections 505(b), 505(j) (21 U.S.C. 354(b) and (j)), 503B, and 704 (21 U.S.C. 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 § 1271.350. B. OTC Monograph Drug Products and Dietary Supplements Section 760 of the FD&C Act provides for mandatory safety reporting for nonprescription human drug products marketed without an approved application as described in the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109– 462), which became law on December 22, 2006. The law requires manufacturers, packers, and distributors of nonprescription, 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. Lhorne on DSK2VPTVN1PROD with NOTICES C. Postmarketing Safety Reports— Changes in Format Starting in June 2015 Current requirements specify that postmarketing adverse experience reports must be submitted on paper on Form FDA 3500A (or the 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 VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 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, go to https://www.gpo.gov/fdsys/pkg/FR2014-06-10/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 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 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 re-processor and whether the device has been reused. V. Proposed Modifications to Existing Forms FDA 3500, 3500A, and 3500B A. General Changes The proposed modifications to Forms FDA 3500 and 3500A reflect changes that will bring the forms into conformation, since the previous authorization in 2012, with current regulations, rules, and guidances. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 B. Changes Proposed for Form FDA 3500 Formatting modifications are proposed to several fields to enhance the clarity and utility of the information collected. In section A2, it is proposed that checkboxes for years, months, weeks, and days be added to permit clarity about the age of the patient. In section A4, it is proposed that checkboxes for pounds (lb) and kilograms (kg) be added to permit clarity about the patient’s weight. To permit clarity and utility for the dates being reported, it is proposed that field labels and instructions be modified to ask the reporter to use the format DD–MMM– YYYY. A watermark will be added to the date fields to prompt the reporter to enter data using this format. This proposed change will reduce the dataentry burden for FDA by making the form more easily scanned by the optical character recognition (OCR) software used by the Agency. This change is proposed for all of the date fields on the form including: A2 (Date of Birth), B2 (Death), B3, B4, C (Returned to Manufacturer On), D7, E4 (Expiration Date), E6, and E7. In recognition of OMB 1997 Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity, and as part of FDA’s Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data (https:// www.fda.gov/downloads/ RegulatoryInformation/Legislation/ FederalFoodDrugand CosmeticActFDCAct/Significant AmendmentstotheFDCAct/FDASIA/ UCM410474.pdf) developed in response to the requirement in section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 (Pub. L.112–144), changes are proposed to the location and formatting of the fields containing data about the patient’s race. It is proposed that race be deleted from the descriptor in section B, field B7, that requests ‘‘Other Relevant History, Including Preexisting Medical Conditions (e.g. allergies, race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.).’’ Instead, it is proposed that a new race and ethnicity field be added to section A, ‘‘Patient Information.’’ The proposed ethnicity field will be numbered 5a and state ‘‘Ethnicity (Check single best answer)’’ with corresponding checkboxes for ‘‘Hispanic/Latino’’ and ‘‘Not Hispanic/Latino.’’ Adjacent to this field, the ‘‘Race’’ field will be numbered 5b and state ‘‘Race (Check all that apply).’’ It will contain checkboxes for ‘‘Asian,’’ ‘‘American Indian or Alaskan Native,’’ ‘‘Black or African American,’’ E:\FR\FM\01JNN1.SGM 01JNN1 Lhorne on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices ‘‘White,’’ and ‘‘Native Hawaiian or Other Pacific Islander.’’ Changes are proposed to the location, formatting, and labeling of fields related to the suspect product and its availability for evaluation to allow the product’s identifying information to be grouped in one place, and increase the likelihood that this information is entered. In section D, field D1 will be used to request data for ‘‘Name and Strength,’’ ‘‘Manufacturer/ Compounder,’’ as well as ‘‘Lot #,’’ and ‘‘NDC # or Unique ID #’’ for up to two suspect medical products. In 2013, the Drug Quality and Security Act (Pub. L. 113–54) added new section 503B to the FD&C Act, under which a compounder may elect to become an outsourcing facility by registering with FDA. Outsourcing facilities are required to report adverse events to FDA in accordance with the content and format requirements established through guidance or regulation under § 310.305. In addition to mandatory reporting, many adverse events related to compounded drugs are reported voluntarily by healthcare professionals and consumers. Therefore, FDA is proposing changes to the voluntary versions of the MedWatch forms (i.e. Forms FDA 3500 and 3500B) to improve the ability to rapidly identify reports involving compounded drugs. The existing field (section D, field D1) that contains the descriptor ‘‘Manufacturer’’ will be relabeled ‘‘Manufacturer/Compounder.’’ Correspondingly, a checkbox for ‘‘Manufacturer/Compounder’’ will be added to the existing field (section G, field G4) ‘‘Also Reported to.’’ It is proposed that a new field be added to the section entitled ‘‘Suspect Products.’’ The new field will be numbered and include a descriptor ‘‘Is the Product Compounded?’’ with corresponding checkboxes for ‘‘Yes’’ or ‘‘No.’’ The new field will also include a descriptor ‘‘Is the Product Over-theCounter’’ with corresponding checkboxes for ‘‘Yes’’ or ‘‘No.’’ The instructions to the form will be updated accordingly. The form remains a threepage form with all the main data fields on page one, with instructions for use and a self-addressed, postage-paid return mailer on the reverse side of page one, and page three being a continuation page for additional information should reporters need extra space. C. Changes Proposed for Form FDA 3500A Formatting modifications are proposed to several fields to enhance the clarity and utility of the information collected. In section A2, it is proposed VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 that checkboxes for years, months, weeks, and days be added to permit clarity about the age of the patient. In section A4, it is proposed that checkboxes for pounds (lb) and kilograms (kg) be added to permit clarity about the patient’s weight. To permit clarity and utility for the dates being reported, it is proposed that field labels and instructions be modified to ask the reporter to use the format DD–MMM– YYYY. A watermark will be added to the date fields to prompt the reporter to enter data using this format. This proposed change will reduce the dataentry burden for FDA by making the form more easily scanned by the OCR software used by the Agency. This change is proposed for all of the date fields on the form including: A2 (Date of Birth), B2 (Death), B3, B4, C7, D4 (Expiration Date), D6, D7, D10 (Returned to Manufacturer on), F6, F8, F11, F13, G4, and H4. In recognition of OMB’s 1997 Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity, and as part of FDA’s Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data (https://www.fda.gov/ downloads/RegulatoryInformation/ Legislation/FederalFoodDrugand CosmeticActFDCAct/Significant AmendmentstotheFDCAct/FDASIA/ UCM410474.pdf) developed in response to the requirement in section 907 of FDASIA, changes are proposed to the location and formatting of the fields containing data about the patient’s race. It is proposed that race be deleted from the descriptor in section B, field B7, that requests ‘‘Other Relevant History, Including Preexisting Medical Conditions (e.g. allergies, race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.).’’ Instead, it is proposed that a new race and ethnicity field be added to section A, ‘‘Patient Information.’’ The proposed ethnicity field will be numbered 5a, and state ‘‘Ethnicity (Check single best answer)’’ with corresponding checkboxes for ‘‘Hispanic/Latino’’ and ‘‘Not Hispanic/Latino.’’ Adjacent to this field, the ‘‘Race’’ field will be numbered 5b, and state ‘‘Race (Check all that apply).’’ It will contain checkboxes for ‘‘Asian,’’ ‘‘American Indian or Alaskan Native,’’ ‘‘Black or African American,’’ ‘‘White,’’ and ‘‘Native Hawaiian or Other Pacific Islander.’’ Changes are proposed to the location, formatting, and labeling of fields related to the suspect product and its availability for evaluation to allow the product’s identifying information to be grouped in one place and increase the likelihood that this information is PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 31045 entered. For consistency and clarity, it is proposed that many of the fields in the suspect products sections on Forms FDA 3500 and 3500A be mirrored. For Form FDA 3500A, it is proposed that the current section C, field C1, ‘‘Name (Give labeled strength & mfr/labeler),’’ also be used to request data for ‘‘Lot #’’ and ‘‘NDC # or Unique ID #.’’ Section C, field C1 will be relabeled ‘‘Name, Manufacturer/Compounder, Strength.’’ Proposed field C1 will contain distinct areas for ‘‘Name and Strength,’’ ‘‘Manufacturer/Compounder,’’ ‘‘NDC # or Unique ID #,’’ and ‘‘Lot #’’ for up to two suspect products. Since the information will now be captured in proposed field C1, separate fields for ‘‘Lot #’’ and ‘‘NDC #/Unique ID #’’ (C6 and C9 from the current form) will not be needed. The currently numbered field C2, ‘‘Dose, Frequency & Route Used,’’ will be renumbered C3. It will also be reformatted to have three distinct areas for dose, frequency, and route, respectively, for up to two suspect products. Current field C3, ‘‘Therapy Dates,’’ will be renumbered C4, and current field C4, ‘‘Diagnosis for Use,’’ will be renumbered C5. Current field C5, ‘‘Event Abated After Use Stopped or Dose Reduced,’’ will be renumbered C9, and field C8, ‘‘Event Reappeared After Reintroduction?’’ will be renumbered C10. The field for expiration date will be renumbered C8, and the field for concomitant medical products and therapy dates (current field C10) will be renumbered C2. As stated previously, in 2013, the Drug Quality and Security Act added new section 503B to the FD&C Act, under which a compounder may elect to become an outsourcing facility by registering with FDA. Outsourcing facilities are required to report adverse events to FDA in accordance with the content and format requirements established through guidance or regulation under § 310.305. To facilitate implementation of this mandatory reporting requirement, changes will need to be made to the existing Form FDA 3500A. It is proposed that a new field be added to section G1 that contains the descriptor ‘‘Compounding Outsourcing Facility 503B?’’ with a corresponding checkbox for ‘‘Yes.’’ It is also proposed that a new field be added to section C, ‘‘Suspect Products.’’ The new field will be numbered C6 and include a descriptor ‘‘Is the Product Compounded?’’ with corresponding checkboxes for ‘‘Yes’’ or ‘‘No’’ (for up to two suspect products). The instructions to the form will be updated accordingly. In addition, a new field numbered C7 will be added and ‘‘Is the Product Overthe-Counter?’’ with corresponding E:\FR\FM\01JNN1.SGM 01JNN1 31046 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices Lhorne on DSK2VPTVN1PROD with NOTICES checkboxes for ‘‘Yes’’ or ‘‘No’’ (for up to two suspect products). The instructions to the form will be updated accordingly. Additionally, for clarity, in section G, field G5, the area labeled ‘‘(A)NDA #’’ will be split into two separate areas— one for ‘‘ANDA #’’ and one for ‘‘NDA #.’’ D. Changes Proposed for Form FDA 3500B For consistency, and to improve the quality of the data received, the changes being proposed on the voluntary Form FDA 3500 (for use by healthcare professionals) are also being proposed on the voluntary Form FDA 3500B (for use by consumers). Formatting modifications are being proposed to several fields to enhance the quality, utility, and clarity of the information. In section D, the field entitled ‘‘Age (at time the problem occurred) or Birth Date’’ will be separated into separate fields for age and date of birth. In the field for ‘‘Age,’’ checkboxes for years, months, weeks, and days will be added to permit clarity about the age of the patient. Similarly, for the field in section D labeled ‘‘Weight,’’ checkboxes for pounds (lb) and kilograms (kg) will be added to permit clarity about the patient’s weight. The instructions will be modified accordingly. To permit clarity about the dates being reported, field labels and instructions will be modified to ask the reporter to use the format DD–MMM–YYYY. A watermark will be added to the field to prompt the reporter to respond using this format. This will also reduce the data entry burden by making the form more easily scanned by the OCR software used by FDA. All of the date fields on the form will be affected by this proposed change. These include section A (date the problem occurred, death), section B (expiration date, date the person first started taking or using this product, date the person stopped taking or using this product), section C (date the implant was put in, date the implant was taken out), section D (date of birth), and section E (today’s date). A formatting modification to the field in section D that is currently labeled ‘‘Race’’ is being proposed in recognition of OMB 1997 Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity, and as part of FDA’s Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data (https://www.fda.gov/ downloads/RegulatoryInformation/ Legislation/FederalFoodDrugand CosmeticActFDCAct/Significant AmendmentstotheFDCAct/FDASIA/ UCM410474.pdf) developed in response to the requirement in section 907 of VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 FDASIA. It is proposed that the field be relabeled ‘‘Race (Check all that apply)’’ and contain checkboxes for ‘‘Asian,’’ ‘‘American Indian or Alaskan Native,’’ ‘‘Black or African American,’’ ‘‘White,’’ and ‘‘Native Hawaiian or Other Pacific Islander.’’ It is also proposed that the field contain an adjacent area labeled ‘‘Ethnicity (Check single best answer)’’ with corresponding checkboxes for ‘‘Hispanic/Latino’’ and ‘‘Not Hispanic/ Latino.’’ As discussed previously in this notice, many adverse events related to compounded drugs are reported voluntarily by healthcare professionals and consumers. Therefore, FDA is proposing changes to the voluntary versions of Forms FDA 3500 and 3500B to improve the Agency’s ability to rapidly identify reports involving compounded drugs. FDA proposes to add a field to section B with the label ‘‘Is the Product Compounded?’’ and corresponding checkboxes for ‘‘Yes’’ or ‘‘No.’’ FDA also proposes to add a field to section B with the label ‘‘Is the Product Over-the-Counter’’ with corresponding checkboxes for ‘‘Yes’’ or ‘‘No.’’ Finally, to improve clarity and to be consistent with Form FDA 3500, FDA proposes to reword the last field of section E that currently asks ‘‘May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the product?’’ to ‘‘If you do NOT want your identity disclosed to the manufacturer, place an ‘X’ in this box.’’ Items that we proposed in the 60-day notice that have changed: The proposed change to Form FDA 3500 to merge sections C and D has been retracted; therefore, the sections will not be resequenced on Form FDA 3500. For the proposed new field ‘‘Is product compounded or over-the-counter’’ (proposed on Forms FDA 3500, 3500A and 3500B), the descriptor ‘‘Check all that apply’’ will be deleted and these will be broken out into two separate questions, in two separate fields, with corresponding ‘‘Yes’’ and ‘‘No’’ checkboxes for up to two suspect products. The proposal to add a new ‘‘compounder’’ checkbox to Form 3500 Field G4 has been retracted. Instead the existing manufacturer checkbox will be relabeled ‘‘manufacturer/compounder.’’ The proposal to add a new field ‘‘Product Available for Evaluation?’’ to the ‘‘suspect products’’ section of the Form FDA 3500A was retracted. The proposed changes outlined above reflect these differences. We have reviewed the name address field for Forms FDA 3500 and 3500A and believe data quality would be improved if separate fields for PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 last name, first name, address, state, ZIP code, and Country were also included instead of one field labeled ‘‘name and address’’ to capture all of that information. In the Federal Register of December 11, 2014 (79 FR 73591), FDA published a 60-day notice requesting public comment on the proposed collection of information. Four comments were received. Comments Affecting All Three FDA Forms (3500, 3500A, 3500B) (Comment 1) One commenter recommended the option of an ‘‘unknown’’ check box for race/ ethnicity. (Response) FDA disagrees with this comment as it is inconsistent with the OMB standards for the classification of Federal data on race and ethnicity. (Comment 2) One commenter requested an implementation date of 18 months after publication of the finalized form. (Response) FDA will allow sufficient time for implementation. Comments Affecting FDA Forms 3500 and 3500A (Comment 1) Section G Field 4 and Section C Field 6: We propose to add a third checkbox labeled ‘‘unknown’’ for when this type of information is not received. Rationale: This information may not be received. (Response) FDA disagrees. G4 corresponds to ‘‘Date Received by Manufacturer’’ on Form FDA 3500A. This is a required element and the manufacturer should always have this information. C6 corresponds to Lot # on the existing Form FDA 3500A. If this information is unknown the field should be left blank. (Comment 2) In Section A1: Along with Patient Identifier, in bracket (first, last) can be added for better identification. (Response) FDA disagrees. Capturing this data may discourage people from submitting voluntary reports. The instructions for the form state ‘‘Do not use the patient’s name or social security number.’’ (Comment 3) In Section A2, Age group can be added. (Response) FDA disagrees. The WG believes that the two data elements proposed for age—Age with checkboxes for days, weeks, months, years, and date of birth in the format DD–MMM–YYYY are sufficient to capture this data. (Comment 4) In Section A3, after selecting Female, a check box should populate for pregnancy with options Yes, No, UNK. Pregnancy can be removed from section B7. E:\FR\FM\01JNN1.SGM 01JNN1 31047 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices (Response) FDA disagrees. The Agency believes pregnancy status is captured sufficiently well through existing field B7. (Comment 5) In Section B1, if Product problem check box is selected then only a text box to enter NDC# should come as National Drug Code is required ONLY when reporting a drug product problem. It can be removed from C9. (Response) FDA disagrees. Product problem is not limited to drug products, and may include medical devices, biologics, and other products which would not have an associated NDC number. (Comment 6) In section B2, Hospitalization—initial or prolonged can be relabeled to only Hospitalization and can have three check boxes; Initial, Prolonged and Hospital discharge summary available. Reporter can select whichever is applicable. (Response) FDA Disagrees. We encourage reporters to put more detail about the hospitalization in the narrative text. (Comment 7) In section B5, Describe Event or Problem, along with individual event terms, seriousness criteria for each event should be populated, so that event-wise seriousness criteria can be identified. (Response) FDA disagrees. An event is considered serious if it meets the regulatory definition, as outlined in §§ 310.305, 314.80, 600.80, 803.3, and 1271. Comments Affecting Form FDA 3500 None. Comments Affecting Form FDA 3500A (Comment 1) Action taken with drug can be added in section C. (Response) FDA disagrees. This information equates to product use stopped or dose reduced, which is already captured on Forms FDA 3500 and 3500A. (Comment 2) We propose that the FDA require medical device adverse reporting use the MedDRA dictionary instead of the Patient Problem Codes. Rationale: Currently when reporting adverse events for medical devices, the current dictionary used is the ‘‘Patient Problem Codes of the Center for Devices and Radiological Health.’’ This dictionary is much smaller (∼800 terms) than the widely used MedDRA dictionary used when reporting adverse events with drugs (∼20.6K terms). Using the MedDRA dictionary in place of the Patient Problem Codes would allow for more accurate recording of patient adverse events. (Response) FDA disagrees. FDA will continue to use Patient Problem Codes for medical devices instead of MedDRA coding. While the MedDRA dictionary is able to adequately capture adverse events with drugs, patient problem codes and device problem codes are more effective at capturing device related adverse events. (Comment 3) Causality scale can be added in Section C. (Response) FDA Disagrees. Causality is not assessed at the reporting level. Refer to §§ 310.305(g), 314.80(k), 600.80(k)(1), and 803.16. (Comment 4) In section C10, Concomitant Medical Products and Therapy Dates (Exclude treatment of event), Dose of concomitant drugs should also be included. (Response) FDA disagrees. Concomitant medical products are not limited to drug products, and may include medical devices, biologics, and other regulated products. As concomitant products are not suspected to be related to the adverse event, it is not necessary to capture the dose. (Comment 5) In Section E1, along with Phone#, Email address can also be included. (Response) FDA disagrees. Form FDA 3500A, section E already includes a field for email address, as does Forms FDA 3500, section G, and 3500B. However, we have reviewed the name address field for Forms FDA 3500 and 3500A and believe data quality would be improved if separate fields for last name, first name, address, state, ZIP code, and Country were also included instead of one field labeled ‘‘name and address’’ to capture all of that information. Comments Affecting Form 3500B (Comment 1) One commenter urged the inclusion of a Spanish version of Form FDA 3500B. (Response) FDA agrees with the importance of communicating the benefits and risks of medical products to healthcare providers and patients, especially underrepresented populations, including those with limited English proficiency. FDA’s language access plan (https:// www.fda.gov/ForConsumers/ ByAudience/MinorityHealth/ ucm412582.htm) outlines some of the steps FDA is taking to improve communications with underrepresented populations. FDA’s drug safety communications are currently translated into Spanish and are available at https://www.fda.gov/Drugs/DrugSafety/ ucm263010.htm. FDA is also working to improve the quality of the data received in adverse event reports received directly from consumers. At this time, FDA plans to focus resources on improving data quality from Englishlanguage consumer reports before evaluating how to best handle product experience information from nonEnglish speaking consumers. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Lhorne on DSK2VPTVN1PROD with NOTICES FDA center/21 CFR section/FDA form Number of respondents Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research: Form FDA 3500 .................................................... Form FDA 3500A (§§ 310.305, 314.80, 314.98, 600.80, 1271.350). Form FDA 3500A (§ 310.305 outsourcing facilities). Center for Devices and Radiological Health: Form FDA 3500 .................................................... Form 3500A (§ 803) ............................................. Center for Food Safety and Applied Nutrition: Form FDA 3500 .................................................... Form 3500A .......................................................... Center for Tobacco Products Form FDA 3500 ........... VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 PO 00000 Number of responses per respondent Total annual responses Average burden per response Total 14,727 599 14,727 58,702 0.66 (40 minutes) ... 1.21 ........................ 9,720 71,029 50 2 100 1.21 ........................ 121 5,233 2,277 1 296 5,233 673,992 0.66 (40 minutes) ... 1.21 ........................ 3,454 815,530 1,793 1,659 39 Frm 00051 1 98 1 1 1 1,793 1,659 39 0.66 (40 minutes) ... 1.21 ........................ 0.66 (40 minutes) .. 1,183 2,007 26 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1 31048 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued Number of respondents FDA center/21 CFR section/FDA form Number of responses per respondent Total annual responses Average burden per response Total All Centers Form FDA 3500B ..................................... 13,750 1 13,750 0.46 (30 minutes) ... 6,325 Total ...................................................................... ........................ ........................ ........................ ................................ 909,395 Dated: May 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–13102 Filed 5–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1798] Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficiency; Public Meeting AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficiency (AATD). Patient-Focused Drug Development is an FDA performance commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to provide FDA with patients’ perspectives on the impact on daily life of AATD. FDA also is seeking patients’ perspectives on the available therapies for this disorder. DATES: The public meeting will be held on September 29, 2015, from 9 a.m. to 3:30 p.m. Registration to attend the meeting must be received by September 15, 2015. Registration from those individuals interested in presenting comments as part of the panel discussions should be received by July 31, 2015. See the SUPPLEMENTARY INFORMATION section for instructions on how to register for the meeting. Submit either electronic or written comments by November 30, 2015. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for public meeting participants (non-FDA employees) is through Lhorne on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 Building 1, where routine security checks will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Barbara Kass, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 1125, Silver Spring, MD 20993, 240–402– 6887, FAX: 301–595–1243, email: PatientFocused_CBER@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background on Patient-Focused Drug Development FDA has selected AATD as the focus of a public meeting under the PatientFocused Drug Development initiative. This initiative involves obtaining a better understanding of patients’ perspectives on the challenges posed by AATD and the impact of current therapies for this condition. The PatientFocused Drug Development initiative is being conducted to fulfill FDA performance commitments that are part of the PDUFA reauthorization under Title I of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144). The full set of performance commitments is available on the FDA Web site at https:// www.fda.gov/downloads/forindustry/ userfees/prescriptiondruguserfee/ ucm270412.pdf. FDA has committed to obtaining the patient perspective on 20 disease areas during the course of PDUFA V. For each disease area, the Agency will conduct a public meeting to discuss the disease and its impact on patients’ daily lives, the types of treatment benefits that matter most to patients, and patients’ perspectives on the adequacy of the available therapies. These meetings will PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 include participation of FDA review divisions, the relevant patient communities, and other interested stakeholders. On April 11, 2013, FDA published a notice in the Federal Register (78 FR 21613) that announced the disease areas for meetings in fiscal years (FY) 2013– 2015, the first 3 years of the 5-year PDUFA V timeframe. The Agency used several criteria outlined in the April 11, 2013, notice to develop the list of disease areas. FDA obtained public comment on the Agency’s proposed criteria and potential disease areas through a public docket and a public meeting that was convened on October 25, 2012. In selecting the set of disease areas, FDA carefully considered the public comments received and the perspectives of review divisions at FDA. FDA has initiated a second public process for determining the disease areas for meetings in FY 2016–2017 and published a notice in the Federal Register on October 8, 2014 (79 FR 60857). More information, including the list of disease areas and a general schedule of meetings, is posted on FDA’s Web site at https://www.fda.gov/ ForIndustry/UserFees/ PrescriptionDrugUserFee/ ucm326192.htm. II. Purpose and Scope of the Meeting The purpose of this Patient-Focused Drug Development meeting is to obtain input on the symptoms and other impacts that matter most to patients with AATD. FDA also intends to seek patients’ perspectives on current approaches to treating this disorder. FDA expects that this information will come directly from patients, caregivers, and patient advocates. Individuals with AATD have low serum levels of Alpha-1-Antitrypsin (AAT, also known as Alpha-1 proteinase inhibitor (A1–PI)) and increased risks of developing a form of chronic obstructive lung disease called emphysema and, less frequently, liver disease. Some AATD patients with emphysema have symptoms of asthma. There are different genetic forms of the disease, but even among people with the same genetic form and similar levels of AAT in their blood, there is tremendous diversity in E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31042-31048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13102]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1960]

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.

-----------------------------------------------------------------------

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 July 1,
2015.

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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.

MedWatch: The FDA Medical Products Reporting Program OMB Control Number
0910-0291--Extension

I. Background

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 (the 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

[[Page 31043]]

supplements. There are no laws or regulations mandating the postmarket
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 (21 U.S.C. 379aa and 379aa-1) of the FD&C
Act. 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.

II. 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 certain adverse reactions following immunization with
vaccines as mandated by the National 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 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/).

III. 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 (Pub. L. 110-85) 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
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.gpo.gov/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

[[Page 31044]]

Safety Reporting Portal (https://www.safetyreporting.hhs.gov/).

IV. Use of Form FDA 3500A (Mandatory Version)

A. Drug and Biological Products

In sections 505(b), 505(j) (21 U.S.C. 354(b) and (j)), 503B, and
704 (21 U.S.C. 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), which became law on
December 22, 2006. The law requires manufacturers, packers, and
distributors of nonprescription, 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
2015

Current requirements specify that postmarketing adverse experience
reports must be submitted on paper on Form FDA 3500A (or the 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, go
to https://www.gpo.gov/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 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 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 re-processor
and whether the device has been reused.

V. Proposed Modifications to Existing Forms FDA 3500, 3500A, and 3500B

A. General Changes

The proposed modifications to Forms FDA 3500 and 3500A reflect
changes that will bring the forms into conformation, since the previous
authorization in 2012, with current regulations, rules, and guidances.

B. Changes Proposed for Form FDA 3500

[[Page 31045]]

``White,'' and ``Native Hawaiian or Other Pacific Islander.''
Changes are proposed to the location, formatting, and labeling of
fields related to the suspect product and its availability for
evaluation to allow the product's identifying information to be grouped
in one place, and increase the likelihood that this information is
entered. In section D, field D1 will be used to request data for ``Name
and Strength,'' ``Manufacturer/Compounder,'' as well as ``Lot #,'' and
``NDC # or Unique ID #'' for up to two suspect medical products.
In 2013, the Drug Quality and Security Act (Pub. L. 113-54) added
new section 503B to the FD&C Act, under which a compounder may elect to
become an outsourcing facility by registering with FDA. Outsourcing
facilities are required to report adverse events to FDA in accordance
with the content and format requirements established through guidance
or regulation under Sec. 310.305. In addition to mandatory reporting,
many adverse events related to compounded drugs are reported
voluntarily by healthcare professionals and consumers. Therefore, FDA
is proposing changes to the voluntary versions of the MedWatch forms
(i.e. Forms FDA 3500 and 3500B) to improve the ability to rapidly
identify reports involving compounded drugs. The existing field
(section D, field D1) that contains the descriptor ``Manufacturer''
will be relabeled ``Manufacturer/Compounder.'' Correspondingly, a
checkbox for ``Manufacturer/Compounder'' will be added to the existing
field (section G, field G4) ``Also Reported to.'' It is proposed that a
new field be added to the section entitled ``Suspect Products.'' The
new field will be numbered and include a descriptor ``Is the Product
Compounded?'' with corresponding checkboxes for ``Yes'' or ``No.''
The new field will also include a descriptor ``Is the Product Over-
the-Counter'' with corresponding checkboxes for ``Yes'' or ``No.'' The
instructions to the form will be updated accordingly. The form remains
a three-page form with all the main data fields on page one, with
instructions for use and a self-addressed, postage-paid return mailer
on the reverse side of page one, and page three being a continuation
page for additional information should reporters need extra space.

C. Changes Proposed for Form FDA 3500A

Formatting modifications are proposed to several fields to enhance
the clarity and utility of the information collected. In section A2, it
is proposed that checkboxes for years, months, weeks, and days be added
to permit clarity about the age of the patient. In section A4, it is
proposed that checkboxes for pounds (lb) and kilograms (kg) be added to
permit clarity about the patient's weight. To permit clarity and
utility for the dates being reported, it is proposed that field labels
and instructions be modified to ask the reporter to use the format DD-
MMM-YYYY. A watermark will be added to the date fields to prompt the
reporter to enter data using this format. This proposed change will
reduce the data-entry burden for FDA by making the form more easily
scanned by the OCR software used by the Agency. This change is proposed
for all of the date fields on the form including: A2 (Date of Birth),
B2 (Death), B3, B4, C7, D4 (Expiration Date), D6, D7, D10 (Returned to
Manufacturer on), F6, F8, F11, F13, G4, and H4.
In recognition of OMB's 1997 Revisions to the Standards for the
Classification of Federal Data on Race and Ethnicity, and as part of
FDA's Action Plan to Enhance the Collection and Availability of
Demographic Subgroup Data (https://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf) developed in
response to the requirement in section 907 of FDASIA, changes are
proposed to the location and formatting of the fields containing data
about the patient's race. It is proposed that race be deleted from the
descriptor in section B, field B7, that requests ``Other Relevant
History, Including Preexisting Medical Conditions (e.g. allergies,
race, pregnancy, smoking and alcohol use, liver/kidney problems,
etc.).'' Instead, it is proposed that a new race and ethnicity field be
added to section A, ``Patient Information.'' The proposed ethnicity
field will be numbered 5a, and state ``Ethnicity (Check single best
answer)'' with corresponding checkboxes for ``Hispanic/Latino'' and
``Not Hispanic/Latino.'' Adjacent to this field, the ``Race'' field
will be numbered 5b, and state ``Race (Check all that apply).'' It will
contain checkboxes for ``Asian,'' ``American Indian or Alaskan
Native,'' ``Black or African American,'' ``White,'' and ``Native
Hawaiian or Other Pacific Islander.''
Changes are proposed to the location, formatting, and labeling of
fields related to the suspect product and its availability for
evaluation to allow the product's identifying information to be grouped
in one place and increase the likelihood that this information is
entered. For consistency and clarity, it is proposed that many of the
fields in the suspect products sections on Forms FDA 3500 and 3500A be
mirrored. For Form FDA 3500A, it is proposed that the current section
C, field C1, ``Name (Give labeled strength & mfr/labeler),'' also be
used to request data for ``Lot #'' and ``NDC # or Unique ID #.''
Section C, field C1 will be relabeled ``Name, Manufacturer/Compounder,
Strength.'' Proposed field C1 will contain distinct areas for ``Name
and Strength,'' ``Manufacturer/Compounder,'' ``NDC # or Unique ID #,''
and ``Lot #'' for up to two suspect products. Since the information
will now be captured in proposed field C1, separate fields for ``Lot
#'' and ``NDC #/Unique ID #'' (C6 and C9 from the current form) will
not be needed. The currently numbered field C2, ``Dose, Frequency &
Route Used,'' will be renumbered C3. It will also be reformatted to
have three distinct areas for dose, frequency, and route, respectively,
for up to two suspect products. Current field C3, ``Therapy Dates,''
will be renumbered C4, and current field C4, ``Diagnosis for Use,''
will be renumbered C5. Current field C5, ``Event Abated After Use
Stopped or Dose Reduced,'' will be renumbered C9, and field C8, ``Event
Reappeared After Reintroduction?'' will be renumbered C10. The field
for expiration date will be renumbered C8, and the field for
concomitant medical products and therapy dates (current field C10) will
be renumbered C2.
As stated previously, in 2013, the Drug Quality and Security Act
added new section 503B to the FD&C Act, under which a compounder may
elect to become an outsourcing facility by registering with FDA.
Outsourcing facilities are required to report adverse events to FDA in
accordance with the content and format requirements established through
guidance or regulation under Sec. 310.305. To facilitate
implementation of this mandatory reporting requirement, changes will
need to be made to the existing Form FDA 3500A. It is proposed that a
new field be added to section G1 that contains the descriptor
``Compounding Outsourcing Facility 503B?'' with a corresponding
checkbox for ``Yes.'' It is also proposed that a new field be added to
section C, ``Suspect Products.'' The new field will be numbered C6 and
include a descriptor ``Is the Product Compounded?'' with corresponding
checkboxes for ``Yes'' or ``No'' (for up to two suspect products). The
instructions to the form will be updated accordingly.
In addition, a new field numbered C7 will be added and ``Is the
Product Over-the-Counter?'' with corresponding

[[Page 31046]]

checkboxes for ``Yes'' or ``No'' (for up to two suspect products). The
instructions to the form will be updated accordingly.
Additionally, for clarity, in section G, field G5, the area labeled
``(A)NDA #'' will be split into two separate areas--one for ``ANDA #''
and one for ``NDA #.''

D. Changes Proposed for Form FDA 3500B

For consistency, and to improve the quality of the data received,
the changes being proposed on the voluntary Form FDA 3500 (for use by
healthcare professionals) are also being proposed on the voluntary Form
FDA 3500B (for use by consumers). Formatting modifications are being
proposed to several fields to enhance the quality, utility, and clarity
of the information. In section D, the field entitled ``Age (at time the
problem occurred) or Birth Date'' will be separated into separate
fields for age and date of birth. In the field for ``Age,'' checkboxes
for years, months, weeks, and days will be added to permit clarity
about the age of the patient. Similarly, for the field in section D
labeled ``Weight,'' checkboxes for pounds (lb) and kilograms (kg) will
be added to permit clarity about the patient's weight. The instructions
will be modified accordingly. To permit clarity about the dates being
reported, field labels and instructions will be modified to ask the
reporter to use the format DD-MMM-YYYY. A watermark will be added to
the field to prompt the reporter to respond using this format. This
will also reduce the data entry burden by making the form more easily
scanned by the OCR software used by FDA. All of the date fields on the
form will be affected by this proposed change. These include section A
(date the problem occurred, death), section B (expiration date, date
the person first started taking or using this product, date the person
stopped taking or using this product), section C (date the implant was
put in, date the implant was taken out), section D (date of birth), and
section E (today's date).
A formatting modification to the field in section D that is
currently labeled ``Race'' is being proposed in recognition of OMB 1997
Revisions to the Standards for the Classification of Federal Data on
Race and Ethnicity, and as part of FDA's Action Plan to Enhance the
Collection and Availability of Demographic Subgroup Data (https://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf) developed in response to the requirement in
section 907 of FDASIA. It is proposed that the field be relabeled
``Race (Check all that apply)'' and contain checkboxes for ``Asian,''
``American Indian or Alaskan Native,'' ``Black or African American,''
``White,'' and ``Native Hawaiian or Other Pacific Islander.'' It is
also proposed that the field contain an adjacent area labeled
``Ethnicity (Check single best answer)'' with corresponding checkboxes
for ``Hispanic/Latino'' and ``Not Hispanic/Latino.''
As discussed previously in this notice, many adverse events related
to compounded drugs are reported voluntarily by healthcare
professionals and consumers. Therefore, FDA is proposing changes to the
voluntary versions of Forms FDA 3500 and 3500B to improve the Agency's
ability to rapidly identify reports involving compounded drugs. FDA
proposes to add a field to section B with the label ``Is the Product
Compounded?'' and corresponding checkboxes for ``Yes'' or ``No.'' FDA
also proposes to add a field to section B with the label ``Is the
Product Over-the-Counter'' with corresponding checkboxes for ``Yes'' or
``No.''
Finally, to improve clarity and to be consistent with Form FDA
3500, FDA proposes to reword the last field of section E that currently
asks ``May we give your name and contact information to the company
that makes the product (manufacturer) to help them evaluate the
product?'' to ``If you do NOT want your identity disclosed to the
manufacturer, place an `X' in this box.''
Items that we proposed in the 60-day notice that have changed: The
proposed change to Form FDA 3500 to merge sections C and D has been
retracted; therefore, the sections will not be re-sequenced on Form FDA
3500. For the proposed new field ``Is product compounded or over-the-
counter'' (proposed on Forms FDA 3500, 3500A and 3500B), the descriptor
``Check all that apply'' will be deleted and these will be broken out
into two separate questions, in two separate fields, with corresponding
``Yes'' and ``No'' checkboxes for up to two suspect products. The
proposal to add a new ``compounder'' checkbox to Form 3500 Field G4 has
been retracted. Instead the existing manufacturer checkbox will be
relabeled ``manufacturer/compounder.'' The proposal to add a new field
``Product Available for Evaluation?'' to the ``suspect products''
section of the Form FDA 3500A was retracted. The proposed changes
outlined above reflect these differences. We have reviewed the name
address field for Forms FDA 3500 and 3500A and believe data quality
would be improved if separate fields for last name, first name,
address, state, ZIP code, and Country were also included instead of one
field labeled ``name and address'' to capture all of that information.
In the Federal Register of December 11, 2014 (79 FR 73591), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four comments were received.
Comments Affecting All Three FDA Forms (3500, 3500A, 3500B)
(Comment 1) One commenter recommended the option of an ``unknown''
check box for race/ethnicity.
(Response) FDA disagrees with this comment as it is inconsistent
with the OMB standards for the classification of Federal data on race
and ethnicity.
(Comment 2) One commenter requested an implementation date of 18
months after publication of the finalized form.
(Response) FDA will allow sufficient time for implementation.
Comments Affecting FDA Forms 3500 and 3500A
(Comment 1) Section G Field 4 and Section C Field 6: We propose to
add a third checkbox labeled ``unknown'' for when this type of
information is not received. Rationale: This information may not be
received.
(Response) FDA disagrees. G4 corresponds to ``Date Received by
Manufacturer'' on Form FDA 3500A. This is a required element and the
manufacturer should always have this information. C6 corresponds to Lot
# on the existing Form FDA 3500A. If this information is unknown the
field should be left blank.
(Comment 2) In Section A1: Along with Patient Identifier, in
bracket (first, last) can be added for better identification.
(Response) FDA disagrees. Capturing this data may discourage people
from submitting voluntary reports. The instructions for the form state
``Do not use the patient's name or social security number.''
(Comment 3) In Section A2, Age group can be added.
(Response) FDA disagrees. The WG believes that the two data
elements proposed for age--Age with checkboxes for days, weeks, months,
years, and date of birth in the format DD-MMM-YYYY are sufficient to
capture this data.
(Comment 4) In Section A3, after selecting Female, a check box
should populate for pregnancy with options Yes, No, UNK. Pregnancy can
be removed from section B7.

[[Page 31047]]

(Response) FDA disagrees. The Agency believes pregnancy status is
captured sufficiently well through existing field B7.
(Comment 5) In Section B1, if Product problem check box is selected
then only a text box to enter NDC# should come as National Drug Code is
required ONLY when reporting a drug product problem. It can be removed
from C9.
(Response) FDA disagrees. Product problem is not limited to drug
products, and may include medical devices, biologics, and other
products which would not have an associated NDC number.
(Comment 6) In section B2, Hospitalization--initial or prolonged
can be relabeled to only Hospitalization and can have three check
boxes; Initial, Prolonged and Hospital discharge summary available.
Reporter can select whichever is applicable.
(Response) FDA Disagrees. We encourage reporters to put more detail
about the hospitalization in the narrative text.
(Comment 7) In section B5, Describe Event or Problem, along with
individual event terms, seriousness criteria for each event should be
populated, so that event-wise seriousness criteria can be identified.
(Response) FDA disagrees. An event is considered serious if it
meets the regulatory definition, as outlined in Sec. Sec. 310.305,
314.80, 600.80, 803.3, and 1271.
Comments Affecting Form FDA 3500
None.
Comments Affecting Form FDA 3500A
(Comment 1) Action taken with drug can be added in section C.
(Response) FDA disagrees. This information equates to product use
stopped or dose reduced, which is already captured on Forms FDA 3500
and 3500A.
(Comment 2) We propose that the FDA require medical device adverse
reporting use the MedDRA dictionary instead of the Patient Problem
Codes. Rationale: Currently when reporting adverse events for medical
devices, the current dictionary used is the ``Patient Problem Codes of
the Center for Devices and Radiological Health.'' This dictionary is
much smaller (~800 terms) than the widely used MedDRA dictionary used
when reporting adverse events with drugs (~20.6K terms). Using the
MedDRA dictionary in place of the Patient Problem Codes would allow for
more accurate recording of patient adverse events.
(Response) FDA disagrees. FDA will continue to use Patient Problem
Codes for medical devices instead of MedDRA coding. While the MedDRA
dictionary is able to adequately capture adverse events with drugs,
patient problem codes and device problem codes are more effective at
capturing device related adverse events.
(Comment 3) Causality scale can be added in Section C.
(Response) FDA Disagrees. Causality is not assessed at the
reporting level. Refer to Sec. Sec. 310.305(g), 314.80(k),
600.80(k)(1), and 803.16.
(Comment 4) In section C10, Concomitant Medical Products and
Therapy Dates (Exclude treatment of event), Dose of concomitant drugs
should also be included.
(Response) FDA disagrees. Concomitant medical products are not
limited to drug products, and may include medical devices, biologics,
and other regulated products. As concomitant products are not suspected
to be related to the adverse event, it is not necessary to capture the
dose.
(Comment 5) In Section E1, along with Phone#, Email address can
also be included.
(Response) FDA disagrees. Form FDA 3500A, section E already
includes a field for email address, as does Forms FDA 3500, section G,
and 3500B. However, we have reviewed the name address field for Forms
FDA 3500 and 3500A and believe data quality would be improved if
separate fields for last name, first name, address, state, ZIP code,
and Country were also included instead of one field labeled ``name and
address'' to capture all of that information.
Comments Affecting Form 3500B
(Comment 1) One commenter urged the inclusion of a Spanish version
of Form FDA 3500B.
(Response) FDA agrees with the importance of communicating the
benefits and risks of medical products to healthcare providers and
patients, especially underrepresented populations, including those with
limited English proficiency. FDA's language access plan (https://www.fda.gov/ForConsumers/ByAudience/MinorityHealth/ucm412582.htm)
outlines some of the steps FDA is taking to improve communications with
underrepresented populations. FDA's drug safety communications are
currently translated into Spanish and are available at https://www.fda.gov/Drugs/DrugSafety/ucm263010.htm. FDA is also working to
improve the quality of the data received in adverse event reports
received directly from consumers. At this time, FDA plans to focus
resources on improving data quality from English-language consumer
reports before evaluating how to best handle product experience
information from non-English speaking consumers.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA center/21 CFR section/FDA form Number of responses per Total annual Average burden per response Total
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research/
Center for Drug Evaluation and Research:
Form FDA 3500............................ 14,727 1 14,727 0.66 (40 minutes)........................ 9,720
Form FDA 3500A (Sec. Sec. 310.305, 599 98 58,702 1.21..................................... 71,029
314.80, 314.98, 600.80, 1271.350).
Form FDA 3500A (Sec. 310.305 50 2 100 1.21..................................... 121
outsourcing facilities).
Center for Devices and Radiological Health:
Form FDA 3500............................ 5,233 1 5,233 0.66 (40 minutes)........................ 3,454
Form 3500A (Sec. 803).................. 2,277 296 673,992 1.21..................................... 815,530
Center for Food Safety and Applied Nutrition:
Form FDA 3500............................ 1,793 1 1,793 0.66 (40 minutes)........................ 1,183
Form 3500A............................... 1,659 1 1,659 1.21..................................... 2,007
Center for Tobacco Products Form FDA 3500.... 39 1 39 0.66 (40 minutes)........................ 26

[[Page 31048]]

All Centers Form FDA 3500B................... 13,750 1 13,750 0.46 (30 minutes)........................ 6,325
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 909,395
--------------------------------------------------------------------------------------------------------------------------------------------------------

Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13102 Filed 5-29-15; 8:45 am]
BILLING CODE 4164-01-P

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