Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting; Electronic Submissions, 10252-10256 [2016-04223]

Download as PDF 10252 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per file is approximately 5,000 hours. We estimate that, annually, 5 respondents will each submit 1 such file, for a total of 25,000 hours. Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04228 Filed 2–26–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0921] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting; Electronic Submissions 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 March 30, 2016. 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 0910–0645. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. asabaliauskas on DSK5VPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 II. Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal—21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 1271.350 and Part 803 (OMB Control Number 0910— 0645)—Revision The Safety Reporting Portal (SRP) and the Electronic Submission Gateway (ESG) are the Agency’s electronic systems for collecting, submitting, and processing adverse event reports, product problem reports, and other safety information for FDA-regulated products. To ensure the safety and identify any risks, harms, or other dangers to health for all FDA-regulated human and animal products, the Agency needs to be informed whenever an adverse event, product quality problem, or product use error occurs. This risk identification process is the first necessary step that allows the Agency to gather the information necessary to be able to evaluate the risk associated with the product and take whatever action is necessary to mitigate or eliminate the public’s exposure to the risk. Some adverse event reports are required to be submitted to FDA (mandatory reporting) and some adverse event reports are submitted voluntarily (voluntary reporting). Requirements regarding mandatory reporting of adverse events or product problems have been codified in 21 CFR parts 310, 314, 514, 600, 803 and 1271, specifically §§ 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56, and 1271.350(a) (21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56, and 1271.350(a)). While adverse event reports submitted to FDA in paper format using Forms FDA 3500, 3500A, 1932, and 1932a, are approved under OMB control numbers 0910–0284 and 0910–0291, this notice solicits comments on adverse event reports filed electronically via the SRP and the ESG, and currently approved under OMB control number 0910–0645. III. The FDA Safety Reporting Portal Rational Questionnaires FDA currently has OMB approval to receive several types of adverse event reports electronically via the SRP using rational questionnaires. In this notice, FDA seeks comments on the extension of OMB approval for the existing rational questionnaires; the proposed revision of the existing rational questionnaire for dietary supplements; the proposed revision of the existing PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 rational questionnaire for tobacco products; a proposed new rational questionnaire that will be used for a new safety reporting program for clinical trials and/or investigational use by the Center for Tobacco Products (CTP); and proposed new rational questionnaires that will be used for food, infant formula, and cosmetic adverse event reports. A. Reportable Food Registry Reports The Food and Drug Administration Amendments Act of 2007 (Pub. L. 110– 085) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by creating section 417 (21 U.S.C. 350f), Reportable Food Registry (RFR or the Registry). Section 417 of the FD&C Act defines ‘‘reportable food’’ as an ‘‘article of food (other than infant formula or dietary supplements) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.’’ (See section 417(a)(2) of the FD&C Act). The Secretary of Health and Human Services (the Secretary) has delegated to the Commissioner of FDA the responsibility for administering the FD&C Act, including section 417. The Congressionally identified purpose of the RFR is to provide ‘‘a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health’’ (121 Stat. 965). We designed the RFR report rational questionnaire to enable FDA to quickly identify, track, and remove from commerce an article of food (other than infant formula and dietary supplements) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) uses the information collected to help ensure that such products are quickly and efficiently removed from the market to prevent foodborne illnesses. The data elements for RFR reports remain unchanged in this request for extension of OMB approval. B. Reports Concerning Experience With Approved New Animal Drugs Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and § 514.80(b) of FDA’s regulations (21 CFR 514.80) require applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) to report E:\FR\FM\29FEN1.SGM 29FEN1 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES adverse drug experiences and product/ manufacturing defects to the Center for Veterinary Medicine (CVM). This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product/manufacturing problems. Postapproval marketing surveillance is important because data previously submitted to FDA may no longer be adequate, as animal drug effects can change over time and less apparent effects may take years to manifest. If an applicant must report adverse drug experiences and product/ manufacturing defects and chooses to do so using the Agency’s paper forms, the applicant is required to use Form FDA 1932, ‘‘Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.’’ Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, ‘‘Transmittal of Periodic Reports and Promotional Material for New Animal Drugs’’ (see § 514.80(d)). Form FDA 1932a, ‘‘Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report’’ allows for voluntary reporting of adverse drug experiences or product/manufacturing defects by veterinarians and the general public. Collection of information using existing paper forms FDA 2301, 1932, and 1932a is approved under OMB control number 0910–0284. Alternatively, an applicant may choose to report adverse drug experiences and product/manufacturing defects electronically. The electronic submission data elements to report adverse drug experiences and product/ manufacturing defects electronically remain unchanged in this request for extension of OMB approval. C. Animal Food Adverse Event and Product Problem Reports Section 1002(b) of the FDAAA directed the Secretary to establish an early warning and surveillance system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food. As part of the effort to fulfill that directive, the Secretary tasked FDA with developing the instrument that would allow consumers to report voluntarily adverse events associated with pet food. We developed the Pet Food Early Warning System rational questionnaire as a userfriendly data collection tool, to make it easy for the public to report a safety problem with pet food. Subsequently, VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 we developed a questionnaire for collecting voluntary adverse event reports associated with livestock food from interested parties such as livestock owners, managers, veterinary staff or other professionals, and concerned citizens. Information collected in these voluntary adverse event reports contribute to CVM’s ability to identify adulteration of the livestock food supply and outbreaks of illness associated with livestock food. The Pet Food Early Warning System and the Livestock Food Reports are designed to identify adulteration of the animal food supply and outbreaks of illness associated with animal food to enable us to quickly identify, track, and remove from commerce such articles of food. We use the information collected to help ensure that such products are quickly and efficiently removed from the market to prevent foodborne illnesses. The electronic submission data elements to report adverse events associated with animal food remain unchanged in this request for extension of OMB approval. D. Voluntary Tobacco Product Adverse Event and Product Problem Reports As noted, this notice seeks comments on two items: (1) A revision to the existing rational questionnaire utilized by consumers and concerned citizens to report tobacco product adverse event or product problems, and (2) a proposed new rational questionnaire that will be used for a new safety reporting program for clinical trials and/or investigational use by CTP. FDA has broad legal authority under the FD&C Act to protect the public health, including protecting Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others. The Family Smoking Prevention and Tobacco Control Act of 2009 (Pub. L. 111–31) (Tobacco Control Act) amended the FD&C Act by creating a new section 909 (21 U.S.C. 387i, Records and Reports on Tobacco Products). Section 909(a) of the FD&C Act (21 U.S.C. 387i(a)) authorizes FDA to establish regulations with respect to mandatory adverse event reports associated with the use of a tobacco product. At this time, FDA collects voluntary adverse event reports associated with the use of tobacco products from interested parties such as health care providers, researchers, consumers, and other users of tobacco products. Information collected in voluntary adverse event reports will contribute to CTP’s ability PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 10253 to be informed of, and assess the real consequences of, tobacco product use. The need for this collection of information derives from our responsibility to obtain current, timely, and policy-relevant information to carry out our statutory functions. The FDA Commissioner is authorized to undertake this collection as specified in section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)). FDA’s CTP has been receiving adverse event and product problem reports through the Safety Reporting Portal since January 2014, when the Safety Reporting Portal for tobacco products first became available to the public. CTP also receives adverse event and product problem reports via paper forms, as approved under OMB Control number 0910–0291. The original questionnaire evolved with input from a National Institutes of Health team of humanfactors experts, from other regulatory agencies, and with extensive input from consumer advocacy groups and the general public. The revised CTP questionnaire along with the proposed new Investigator questionnaire build on the foundation of the original rational questionnaire to make the report’s data more useful, analyzable, and specific. The changes from the original to the new questionnaire are made in an effort to make the questions more understandable and specific. In some instances, alterations were made to the list of values to choose from by the end user in order to include values more pertinent to CTP’s current and future data collection needs. In other instances, questions were added that will provide FDA with more specific, analyzable information. In still other instances, questions were removed altogether in an effort to streamline the questionnaire and make it more userfriendly. All changes were made with the goal of providing FDA more pertinent information while minimizing the burden on the respondent. Finally, we note that respondents unable to submit reports using the electronic system will still be able to provide their information by paper form (by mail or fax) or telephone. The proposed new rational questionnaire will be used by tobacco product investigators in clinical trials with investigational tobacco products. In addition to the information collected by the existing rational questionnaire for tobacco products, the proposed rational questionnaire will collect identifying information specific to the clinical trial or investigational product such as clinical protocol numbers or other identifying features to pinpoint under E:\FR\FM\29FEN1.SGM 29FEN1 10254 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices which test or protocol the adverse event occurred. Both CTP voluntary rational questionnaires will capture tobaccospecific adverse event and product problem information from voluntary reporting entities such as health care providers, researchers, consumers, and other users of tobacco products. To carry out its responsibilities, FDA needs to be informed when an adverse event, product problem, or error with use is suspected or identified. When FDA receives tobacco-specific adverse event and product problem information, it will use the information to assess and evaluate the risk associated with the product, and then FDA will take whatever action is necessary to reduce, mitigate, or eliminate the public’s exposure to the risk through regulatory and public health interventions. E. Dietary Supplement Adverse Event Reports The Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) (Pub. L. 109–462, 120 Stat. 3469) amended the FD&C Act with respect to serious adverse event reporting and recordkeeping for dietary supplements and nonprescription drugs marketed without an approved application. Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)) requires the manufacturer, packer, or distributor whose name (under section 403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1)) appears on the label of a dietary supplement marketed in the United States to submit to FDA all serious adverse event reports associated with the use of a dietary supplement, accompanied by a copy of the product label. The manufacturer, packer, or distributor of a dietary supplement is required by the DSNDCPA to use the MedWatch form (Form FDA 3500A) when submitting a serious adverse event report to FDA. In addition, under section 761(c)(2) of the FD&C Act, the submitter of the serious adverse event report (referred to in the statute as the ‘‘responsible person’’) is required to submit to FDA a followup report of any related new medical information the responsible person receives within 1 year of the initial report. As required by section 3(d)(3) of the DSNDCPA, FDA issued guidance to describe the minimum data elements for serious adverse event reports for dietary supplements. The guidance document entitled ‘‘Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,’’ discusses how, when, and where to submit serious adverse event reports for dietary supplements and followup reports. The guidance also provides FDA’s recommendation on records maintenance and access for serious and non-serious adverse event reports and related documents. Reporting of serious adverse events for dietary supplements to FDA serves as an early warning sign of potential public health issues associated with such products. Without notification of all serious adverse events associated with dietary supplements, FDA would be unable to investigate and followup promptly, which in turn could cause delays in alerting the public when safety problems are found. In addition, the information received provides a reliable mechanism to track patterns of adulteration in food that supports efforts by FDA to target limited inspection resources to protect the public health. FDA uses the information collected to help ensure that such products are quickly and efficiently removed from the market to prevent foodborne illnesses. Paper mandatory dietary supplement adverse event reports are submitted to FDA on the MedWatch form, Form FDA 3500A, and paper voluntary reports are submitted on Form FDA 3500. Forms FDA 3500 and 3500A are available as fillable pdf forms. Dietary supplement adverse event reports may be electronically submitted to the Agency via the SRP. This method of submission is voluntary. A manufacturer, packer, or distributor of a dietary supplement who is unable to or chooses not to submit reports using the electronic system will still be able to provide their information by paper MedWatch form, Form FDA 3500A (by mail or fax). There is no change to the mandatory information previously required on the MedWatch form. CFSAN is making available the option to submit the same information via electronic means. However, we are proposing to add a new voluntary question on the mandatory report rational questionnaire and a new voluntary question on the voluntary report rational questionnaire. The text of the new questions is provided in table form in table 1. Finally, we are proposing to change the following data elements from a text box method of response to an individual question and answer method: Race and known allergies. TABLE 1—PROPOSED NEW QUESTIONS ON THE DIETARY SUPPLEMENT RATIONAL QUESTIONNAIRE Is response mandatory or voluntary? Mandatory Report—In the Contact Information section, we propose to add, ‘‘Please provide contact information for you, the person who is filling out this report.’’. Voluntary Report—In the Product Information section, we propose to request the ingredients of the suspect and concomitant product(s), as provided on the label of the product(s). asabaliauskas on DSK5VPTVN1PROD with NOTICES Text of new question Voluntary, and only displayed if the person filling out the report is reporting on behalf of a responsible person, such as a contractor, and has not created an account on the SRP. Voluntary. The reporting and recordkeeping requirements of the FD&C Act for dietary supplement adverse event reports and the recommendations of the guidance document were first approved in 2009 under OMB control number 0910–0635. OMB approved the extension of the 0910–0635 collection of information in February 2013. OMB approved the electronic submission of dietary supplement adverse event VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 reports via the SRP under OMB control number 0910–0645 in June 2013. Burden hours are also reported under OMB control number 0910–0291 reflecting the submission of dietary supplement adverse event reports on the paper MedWatch form, Form FDA 3500A. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 F. Food, Infant Formula, and Cosmetic Adverse Event Reports We are planning proposed new rational questionnaire functionality that will be used for food, infant formula, and cosmetic adverse event reports. Currently, voluntary adverse event reports for such products are submitted on Form FDA 3500, which is available as a fillable pdf form. However, we have not developed rational questionnaires E:\FR\FM\29FEN1.SGM 29FEN1 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices by which these reports may be electronically submitted to us via the SRP. In addition, MedWatch forms, although recently updated with field labels and descriptions to better clarify for reporters the range of reportable products, do not specifically include questions relevant for the analysis of adverse events related to food, infant formula, and cosmetics. The proposed food, infant formula, and cosmetics rational questionnaire functionality will 10255 operate in a manner similar to the dietary supplement rational questionnaire and will include specific questions relevant for the analysis of adverse events related to food, infant formula, and cosmetics. TABLE 2—NEW QUESTIONS ON THE PROPOSED FOOD, INFANT FORMULA, AND COSMETICS RATIONAL QUESTIONNAIRES FOR BOTH SUSPECT AND CONCOMITANT PRODUCTS Is response mandatory or voluntary? Text of new question For food products: .................................................................................................................................................................................. ‘‘Is this a medical food?’’ ‘‘If so, what was the diagnosis or reason for use?’’ ‘‘How was the product prepared?’’ For infant formula products: ................................................................................................................................................................... ‘‘What form of the product was used: Concentrate, powder or ready to serve?’’ ‘‘Is this a specialized infant formula?’’ ‘‘If so, what was the diagnosis or reason for use?’’ ‘‘How was the product prepared?’’ ‘‘What type of water was used to prepare the formula?’’ For cosmetic products: ........................................................................................................................................................................... ‘‘Do you have existing skin conditions?’’ ‘‘How soon did symptoms develop after using the product?’’ ‘‘Did the intensity of the reaction get worse with time?’’ ‘‘Where did the reaction develop?’’ ‘‘What treatments were sought for this adverse event?’’ ‘‘What ingredient do you suspect caused the adverse event?’’ ‘‘Has the problem resolved?’’ ‘‘Does the product label contain a warning or caution statement?’’ IV. Information Collection Burden Estimate submitting mandatory or voluntary adverse event reports electronically to FDA via the ESG or the SRP regarding FDA-regulated products. In the Federal Register of November 18, 2015 (80 FR 72071) FDA published Description of respondents: The respondents to this collection of information include all persons Voluntary. Voluntary. Voluntary. a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Voluntary Adverse Event Report via the SRP (Other than RFR Reports). Mandatory Adverse Event Report via the SRP (Other than RFR Reports). Mandatory Adverse Event Report via the ESG (Gateway-toGateway transmission). Mandatory and Voluntary RFR Reports via the SRP ............ Total ................................................................................ asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 There Number of responses per respondent Total annual responses 1,786 1 1,786 636 1 636 1,864,035 1 1,864,035 1,200 1 1,200 ........................ ........................ ........................ Average burden per response 0.6 ............... (36 minutes) 1.0 ............... 0.6 (36 0.6 (36 Total hours 1,072 636 ............... minutes) ............... minutes) 1,118,421 ..................... 1,120,849 720 are no capital costs or operating and maintenance costs associated with this collection of information. The Agency’s estimate of the number of respondents and the total annual responses in table 3, Estimated Annual Reporting Burden, is based primarily on mandatory and voluntary adverse event reports electronically submitted to the Agency. The estimated total annual responses are based on initial reports. Followup reports, if any, are not counted as new reports. Based on its experience with adverse event VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 reporting, FDA estimates that it will take a respondent 0.6 hour to submit a voluntary adverse event report via the SRP, 1 hour to submit a mandatory adverse event report via the SRP, and 0.6 hour to submit a mandatory adverse event report via the ESG (gateway-togateway transmission). Both mandatory and voluntary RFR reports must be submitted via the SRP. FDA estimates that it will take a respondent 0.6 hour PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 to submit a RFR report, whether the submission is mandatory or voluntary. The burden hours required to complete paper FDA reporting forms (Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control numbers 0910–0284 and 0910–0291. While FDA does not charge for the use of the ESG, FDA requires respondents to obtain a public key infrastructure certificate in order to set up the account. E:\FR\FM\29FEN1.SGM 29FEN1 10256 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices This can be obtained in-house or outsourced by purchasing a public key certificate that is valid for 1 year to 3 years. The certificate typically costs from $20 to $30. Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–04277 Filed 2–26–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–04223 Filed 2–26–16; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration [Docket No. FDA–2016–N–0586] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Food and Drug Administration Tribal Consultation Policy; Availability; Request for Comments [Docket No. FDA–2015–N–2126] AGENCY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco Among LGBT (RESPECT) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT)’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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: On January 26, 2016, the Agency submitted a proposed collection of information entitled ‘‘Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT)’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0808. The approval expires on January 31, 2019. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. April 4, 2016 asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 Food and Drug Administration, HHS. Notice of availability; request for comments. ACTION: The Food and Drug Administration (FDA or we) is announcing the availability of the draft FDA Tribal Consultation Policy. We are also announcing the establishment of a docket to receive comments on the draft FDA Tribal Consultation Policy. The purpose of the FDA Tribal Consultation Policy, when finalized, is to establish clear policies to further the governmentto-government relationship between FDA and American Indian and Alaskan Native Tribes (hereafter, Indian Tribes) and facilitate tribal consultation with FDA. The draft FDA Tribal Consultation Policy provides background on FDA’s mission and organizational structure and sets out principles and guidelines for the tribal consultation process. DATES: Comments must be received on or before May 31, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2016–N–0586 for ‘‘Draft FDA Tribal Consultation Policy; Availability; Request for Comments.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 E:\FR\FM\29FEN1.SGM 29FEN1

Agencies

[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10252-10256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04223]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0921]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event
Reporting; Electronic Submissions

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 March
30, 2016.

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 0910-0645.
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:

I. Background

In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance.

II. Electronic Submission of Food and Drug Administration Adverse Event
Reports and Other Safety Information Using the Electronic Submission
Gateway and the Safety Reporting Portal--21 CFR 310.305, 314.80,
314.98, 314.540, 514.80, 600.80, 1271.350 and Part 803 (OMB Control
Number 0910--0645)--Revision

The Safety Reporting Portal (SRP) and the Electronic Submission
Gateway (ESG) are the Agency's electronic systems for collecting,
submitting, and processing adverse event reports, product problem
reports, and other safety information for FDA-regulated products. To
ensure the safety and identify any risks, harms, or other dangers to
health for all FDA-regulated human and animal products, the Agency
needs to be informed whenever an adverse event, product quality
problem, or product use error occurs. This risk identification process
is the first necessary step that allows the Agency to gather the
information necessary to be able to evaluate the risk associated with
the product and take whatever action is necessary to mitigate or
eliminate the public's exposure to the risk.
Some adverse event reports are required to be submitted to FDA
(mandatory reporting) and some adverse event reports are submitted
voluntarily (voluntary reporting). Requirements regarding mandatory
reporting of adverse events or product problems have been codified in
21 CFR parts 310, 314, 514, 600, 803 and 1271, specifically Sec. Sec.
310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 803.30, 803.40,
803.50, 803.53, 803.56, and 1271.350(a) (21 CFR 310.305, 314.80,
314.98, 314.540, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53,
803.56, and 1271.350(a)). While adverse event reports submitted to FDA
in paper format using Forms FDA 3500, 3500A, 1932, and 1932a, are
approved under OMB control numbers 0910-0284 and 0910-0291, this notice
solicits comments on adverse event reports filed electronically via the
SRP and the ESG, and currently approved under OMB control number 0910-
0645.

III. The FDA Safety Reporting Portal Rational Questionnaires

FDA currently has OMB approval to receive several types of adverse
event reports electronically via the SRP using rational questionnaires.
In this notice, FDA seeks comments on the extension of OMB approval for
the existing rational questionnaires; the proposed revision of the
existing rational questionnaire for dietary supplements; the proposed
revision of the existing rational questionnaire for tobacco products; a
proposed new rational questionnaire that will be used for a new safety
reporting program for clinical trials and/or investigational use by the
Center for Tobacco Products (CTP); and proposed new rational
questionnaires that will be used for food, infant formula, and cosmetic
adverse event reports.

A. Reportable Food Registry Reports

The Food and Drug Administration Amendments Act of 2007 (Pub. L.
110-085) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) by creating section 417 (21 U.S.C. 350f), Reportable Food
Registry (RFR or the Registry). Section 417 of the FD&C Act defines
``reportable food'' as an ``article of food (other than infant formula
or dietary supplements) for which there is a reasonable probability
that the use of, or exposure to, such article of food will cause
serious adverse health consequences or death to humans or animals.''
(See section 417(a)(2) of the FD&C Act). The Secretary of Health and
Human Services (the Secretary) has delegated to the Commissioner of FDA
the responsibility for administering the FD&C Act, including section
417. The Congressionally identified purpose of the RFR is to provide
``a reliable mechanism to track patterns of adulteration in food
[which] would support efforts by the Food and Drug Administration to
target limited inspection resources to protect the public health'' (121
Stat. 965). We designed the RFR report rational questionnaire to enable
FDA to quickly identify, track, and remove from commerce an article of
food (other than infant formula and dietary supplements) for which
there is a reasonable probability that the use of, or exposure to, such
article of food will cause serious adverse health consequences or death
to humans or animals. FDA's Center for Food Safety and Applied
Nutrition (CFSAN) uses the information collected to help ensure that
such products are quickly and efficiently removed from the market to
prevent foodborne illnesses. The data elements for RFR reports remain
unchanged in this request for extension of OMB approval.

B. Reports Concerning Experience With Approved New Animal Drugs

Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and Sec.
514.80(b) of FDA's regulations (21 CFR 514.80) require applicants of
approved new animal drug applications (NADAs) and approved abbreviated
new animal drug applications (ANADAs) to report

[[Page 10253]]

adverse drug experiences and product/manufacturing defects to the
Center for Veterinary Medicine (CVM). This continuous monitoring of
approved NADAs and ANADAs affords the primary means by which FDA
obtains information regarding potential problems with the safety and
efficacy of marketed approved new animal drugs as well as potential
product/manufacturing problems. Postapproval marketing surveillance is
important because data previously submitted to FDA may no longer be
adequate, as animal drug effects can change over time and less apparent
effects may take years to manifest.
If an applicant must report adverse drug experiences and product/
manufacturing defects and chooses to do so using the Agency's paper
forms, the applicant is required to use Form FDA 1932, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.''
Periodic drug experience reports and special drug experience reports
must be accompanied by a completed Form FDA 2301, ``Transmittal of
Periodic Reports and Promotional Material for New Animal Drugs'' (see
Sec. 514.80(d)). Form FDA 1932a, ``Veterinary Adverse Drug Reaction,
Lack of Effectiveness or Product Defect Report'' allows for voluntary
reporting of adverse drug experiences or product/manufacturing defects
by veterinarians and the general public. Collection of information
using existing paper forms FDA 2301, 1932, and 1932a is approved under
OMB control number 0910-0284.
Alternatively, an applicant may choose to report adverse drug
experiences and product/manufacturing defects electronically. The
electronic submission data elements to report adverse drug experiences
and product/manufacturing defects electronically remain unchanged in
this request for extension of OMB approval.

C. Animal Food Adverse Event and Product Problem Reports

Section 1002(b) of the FDAAA directed the Secretary to establish an
early warning and surveillance system to identify adulteration of the
pet food supply and outbreaks of illness associated with pet food. As
part of the effort to fulfill that directive, the Secretary tasked FDA
with developing the instrument that would allow consumers to report
voluntarily adverse events associated with pet food. We developed the
Pet Food Early Warning System rational questionnaire as a user-friendly
data collection tool, to make it easy for the public to report a safety
problem with pet food. Subsequently, we developed a questionnaire for
collecting voluntary adverse event reports associated with livestock
food from interested parties such as livestock owners, managers,
veterinary staff or other professionals, and concerned citizens.
Information collected in these voluntary adverse event reports
contribute to CVM's ability to identify adulteration of the livestock
food supply and outbreaks of illness associated with livestock food.
The Pet Food Early Warning System and the Livestock Food Reports are
designed to identify adulteration of the animal food supply and
outbreaks of illness associated with animal food to enable us to
quickly identify, track, and remove from commerce such articles of
food. We use the information collected to help ensure that such
products are quickly and efficiently removed from the market to prevent
foodborne illnesses. The electronic submission data elements to report
adverse events associated with animal food remain unchanged in this
request for extension of OMB approval.

D. Voluntary Tobacco Product Adverse Event and Product Problem Reports

As noted, this notice seeks comments on two items: (1) A revision
to the existing rational questionnaire utilized by consumers and
concerned citizens to report tobacco product adverse event or product
problems, and (2) a proposed new rational questionnaire that will be
used for a new safety reporting program for clinical trials and/or
investigational use by CTP.
FDA has broad legal authority under the FD&C Act to protect the
public health, including protecting Americans from tobacco-related
death and disease by regulating the manufacture, distribution, and
marketing of tobacco products and by educating the public, especially
young people, about tobacco products and the dangers their use poses to
themselves and others. The Family Smoking Prevention and Tobacco
Control Act of 2009 (Pub. L. 111-31) (Tobacco Control Act) amended the
FD&C Act by creating a new section 909 (21 U.S.C. 387i, Records and
Reports on Tobacco Products). Section 909(a) of the FD&C Act (21 U.S.C.
387i(a)) authorizes FDA to establish regulations with respect to
mandatory adverse event reports associated with the use of a tobacco
product. At this time, FDA collects voluntary adverse event reports
associated with the use of tobacco products from interested parties
such as health care providers, researchers, consumers, and other users
of tobacco products. Information collected in voluntary adverse event
reports will contribute to CTP's ability to be informed of, and assess
the real consequences of, tobacco product use.
The need for this collection of information derives from our
responsibility to obtain current, timely, and policy-relevant
information to carry out our statutory functions. The FDA Commissioner
is authorized to undertake this collection as specified in section
1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)).
FDA's CTP has been receiving adverse event and product problem
reports through the Safety Reporting Portal since January 2014, when
the Safety Reporting Portal for tobacco products first became available
to the public. CTP also receives adverse event and product problem
reports via paper forms, as approved under OMB Control number 0910-
0291. The original questionnaire evolved with input from a National
Institutes of Health team of human-factors experts, from other
regulatory agencies, and with extensive input from consumer advocacy
groups and the general public. The revised CTP questionnaire along with
the proposed new Investigator questionnaire build on the foundation of
the original rational questionnaire to make the report's data more
useful, analyzable, and specific. The changes from the original to the
new questionnaire are made in an effort to make the questions more
understandable and specific. In some instances, alterations were made
to the list of values to choose from by the end user in order to
include values more pertinent to CTP's current and future data
collection needs. In other instances, questions were added that will
provide FDA with more specific, analyzable information. In still other
instances, questions were removed altogether in an effort to streamline
the questionnaire and make it more user-friendly. All changes were made
with the goal of providing FDA more pertinent information while
minimizing the burden on the respondent. Finally, we note that
respondents unable to submit reports using the electronic system will
still be able to provide their information by paper form (by mail or
fax) or telephone.
The proposed new rational questionnaire will be used by tobacco
product investigators in clinical trials with investigational tobacco
products. In addition to the information collected by the existing
rational questionnaire for tobacco products, the proposed rational
questionnaire will collect identifying information specific to the
clinical trial or investigational product such as clinical protocol
numbers or other identifying features to pinpoint under

[[Page 10254]]

which test or protocol the adverse event occurred.
Both CTP voluntary rational questionnaires will capture tobacco-
specific adverse event and product problem information from voluntary
reporting entities such as health care providers, researchers,
consumers, and other users of tobacco products. To carry out its
responsibilities, FDA needs to be informed when an adverse event,
product problem, or error with use is suspected or identified. When FDA
receives tobacco-specific adverse event and product problem
information, it will use the information to assess and evaluate the
risk associated with the product, and then FDA will take whatever
action is necessary to reduce, mitigate, or eliminate the public's
exposure to the risk through regulatory and public health
interventions.

E. Dietary Supplement Adverse Event Reports

The Dietary Supplement and Nonprescription Drug Consumer Protection
Act (DSNDCPA) (Pub. L. 109-462, 120 Stat. 3469) amended the FD&C Act
with respect to serious adverse event reporting and recordkeeping for
dietary supplements and nonprescription drugs marketed without an
approved application.
Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1))
requires the manufacturer, packer, or distributor whose name (under
section 403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1)) appears on the
label of a dietary supplement marketed in the United States to submit
to FDA all serious adverse event reports associated with the use of a
dietary supplement, accompanied by a copy of the product label. The
manufacturer, packer, or distributor of a dietary supplement is
required by the DSNDCPA to use the MedWatch form (Form FDA 3500A) when
submitting a serious adverse event report to FDA. In addition, under
section 761(c)(2) of the FD&C Act, the submitter of the serious adverse
event report (referred to in the statute as the ``responsible person'')
is required to submit to FDA a followup report of any related new
medical information the responsible person receives within 1 year of
the initial report.
As required by section 3(d)(3) of the DSNDCPA, FDA issued guidance
to describe the minimum data elements for serious adverse event reports
for dietary supplements. The guidance document entitled ``Guidance for
Industry: Questions and Answers Regarding Adverse Event Reporting and
Recordkeeping for Dietary Supplements as Required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act,''
discusses how, when, and where to submit serious adverse event reports
for dietary supplements and followup reports. The guidance also
provides FDA's recommendation on records maintenance and access for
serious and non-serious adverse event reports and related documents.
Reporting of serious adverse events for dietary supplements to FDA
serves as an early warning sign of potential public health issues
associated with such products. Without notification of all serious
adverse events associated with dietary supplements, FDA would be unable
to investigate and followup promptly, which in turn could cause delays
in alerting the public when safety problems are found. In addition, the
information received provides a reliable mechanism to track patterns of
adulteration in food that supports efforts by FDA to target limited
inspection resources to protect the public health. FDA uses the
information collected to help ensure that such products are quickly and
efficiently removed from the market to prevent foodborne illnesses.
Paper mandatory dietary supplement adverse event reports are
submitted to FDA on the MedWatch form, Form FDA 3500A, and paper
voluntary reports are submitted on Form FDA 3500. Forms FDA 3500 and
3500A are available as fillable pdf forms. Dietary supplement adverse
event reports may be electronically submitted to the Agency via the
SRP. This method of submission is voluntary. A manufacturer, packer, or
distributor of a dietary supplement who is unable to or chooses not to
submit reports using the electronic system will still be able to
provide their information by paper MedWatch form, Form FDA 3500A (by
mail or fax). There is no change to the mandatory information
previously required on the MedWatch form. CFSAN is making available the
option to submit the same information via electronic means. However, we
are proposing to add a new voluntary question on the mandatory report
rational questionnaire and a new voluntary question on the voluntary
report rational questionnaire. The text of the new questions is
provided in table form in table 1. Finally, we are proposing to change
the following data elements from a text box method of response to an
individual question and answer method: Race and known allergies.

Table 1--Proposed New Questions on the Dietary Supplement Rational
Questionnaire
------------------------------------------------------------------------
Is response mandatory or
Text of new question voluntary?
------------------------------------------------------------------------
Mandatory Report--In the Contact Voluntary, and only displayed
Information section, we propose to if the person filling out the
add, ``Please provide contact report is reporting on behalf
information for you, the person who is of a responsible person, such
filling out this report.''. as a contractor, and has not
created an account on the SRP.
Voluntary Report--In the Product Voluntary.
Information section, we propose to
request the ingredients of the suspect
and concomitant product(s), as
provided on the label of the
product(s).
------------------------------------------------------------------------

The reporting and recordkeeping requirements of the FD&C Act for
dietary supplement adverse event reports and the recommendations of the
guidance document were first approved in 2009 under OMB control number
0910-0635. OMB approved the extension of the 0910-0635 collection of
information in February 2013. OMB approved the electronic submission of
dietary supplement adverse event reports via the SRP under OMB control
number 0910-0645 in June 2013. Burden hours are also reported under OMB
control number 0910-0291 reflecting the submission of dietary
supplement adverse event reports on the paper MedWatch form, Form FDA
3500A.

F. Food, Infant Formula, and Cosmetic Adverse Event Reports

We are planning proposed new rational questionnaire functionality
that will be used for food, infant formula, and cosmetic adverse event
reports. Currently, voluntary adverse event reports for such products
are submitted on Form FDA 3500, which is available as a fillable pdf
form. However, we have not developed rational questionnaires

[[Page 10255]]

by which these reports may be electronically submitted to us via the
SRP. In addition, MedWatch forms, although recently updated with field
labels and descriptions to better clarify for reporters the range of
reportable products, do not specifically include questions relevant for
the analysis of adverse events related to food, infant formula, and
cosmetics. The proposed food, infant formula, and cosmetics rational
questionnaire functionality will operate in a manner similar to the
dietary supplement rational questionnaire and will include specific
questions relevant for the analysis of adverse events related to food,
infant formula, and cosmetics.

Table 2--New Questions on the Proposed Food, Infant Formula, and
Cosmetics Rational Questionnaires for Both Suspect and Concomitant
Products
------------------------------------------------------------------------
Is response mandatory or
Text of new question voluntary?
------------------------------------------------------------------------
For food products:........................ Voluntary.
``Is this a medical food?''
``If so, what was the diagnosis or
reason for use?''
``How was the product prepared?''
For infant formula products:.............. Voluntary.
``What form of the product was used:
Concentrate, powder or ready to
serve?''
``Is this a specialized infant
formula?''
``If so, what was the diagnosis or
reason for use?''
``How was the product prepared?''
``What type of water was used to
prepare the formula?''
For cosmetic products:.................... Voluntary.
``Do you have existing skin
conditions?''
``How soon did symptoms develop after
using the product?''
``Did the intensity of the reaction
get worse with time?''
``Where did the reaction develop?''
``What treatments were sought for this
adverse event?''
``What ingredient do you suspect
caused the adverse event?''
``Has the problem resolved?''
``Does the product label contain a
warning or caution statement?''
------------------------------------------------------------------------

IV. Information Collection Burden Estimate

Description of respondents: The respondents to this collection of
information include all persons submitting mandatory or voluntary
adverse event reports electronically to FDA via the ESG or the SRP
regarding FDA-regulated products.
In the Federal Register of November 18, 2015 (80 FR 72071) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:

Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Voluntary Adverse Event 1,786 1 1,786 0.6.............. 1,072
Report via the SRP (Other (36 minutes).....
than RFR Reports).
Mandatory Adverse Event 636 1 636 1.0.............. 636
Report via the SRP (Other
than RFR Reports).
Mandatory Adverse Event 1,864,035 1 1,864,035 0.6.............. 1,118,421
Report via the ESG (Gateway- (36 minutes).....
to-Gateway transmission).
Mandatory and Voluntary RFR 1,200 1 1,200 0.6.............. 720
Reports via the SRP. (36 minutes).....
----------------------------------------------------------------------------------
Total.................... .............. .............. .............. ................. 1,120,849
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The Agency's estimate of the number of respondents and the total
annual responses in table 3, Estimated Annual Reporting Burden, is
based primarily on mandatory and voluntary adverse event reports
electronically submitted to the Agency. The estimated total annual
responses are based on initial reports. Followup reports, if any, are
not counted as new reports. Based on its experience with adverse event
reporting, FDA estimates that it will take a respondent 0.6 hour to
submit a voluntary adverse event report via the SRP, 1 hour to submit a
mandatory adverse event report via the SRP, and 0.6 hour to submit a
mandatory adverse event report via the ESG (gateway-to-gateway
transmission). Both mandatory and voluntary RFR reports must be
submitted via the SRP. FDA estimates that it will take a respondent 0.6
hour to submit a RFR report, whether the submission is mandatory or
voluntary.
The burden hours required to complete paper FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control
numbers 0910-0284 and 0910-0291. While FDA does not charge for the use
of the ESG, FDA requires respondents to obtain a public key
infrastructure certificate in order to set up the account.

[[Page 10256]]

This can be obtained in-house or outsourced by purchasing a public key
certificate that is valid for 1 year to 3 years. The certificate
typically costs from $20 to $30.

Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04223 Filed 2-26-16; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.