80 FR 72071 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting; Electronic Submissions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 222 (November 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 222 (November 18, 2015)
| Page Range | 72071-72075 | |
| FR Document | 2015-29407 |
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)] [Notices] [Pages 72071-72075] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29407] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0921] Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting; Electronic Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of the FDA Electronic Submission Gateway (ESG) and the Safety Reporting Portal (SRP) to collect adverse event reports and other safety information for FDA- regulated products. DATES: Submit either electronic or written comments on the collection of information by January 19, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://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-2012-N-0921 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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 information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets [[Page 72072]] Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 SRP and the 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. 110-85) (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 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 [[Page 72073]] 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 objective 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 change from the original to the new questionnaire is simply a change in wording, to make the question more understandable and specific. In other instances, alterations were made to the long 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 still other instances, questions were removed altogether in an effort to streamline the questionnaire and make it more user-friendly. Finally, we note that users who are 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 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. [[Page 72074]] 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 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 Information section, we propose to add, displayed if the person ``Please provide contact information for filling out the report is you, the person who is filling out this reporting on behalf of a report.'' responsible person, such 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 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. [[Page 72075]] 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. FDA estimates 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 Report 1,786 1 1,786 0.6 1,072 via the SRP (Other than RFR (36 minutes) Reports)....................... Mandatory Adverse Event Report 636 1 636 1.0 636 via the SRP (Other than RFR Reports)....................... Mandatory Adverse Event Report 1,864,035 1 1,864,035 0.6 1,118,421 via the ESG (Gateway-to-Gateway (36 minutes) 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. 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: November 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29407 Filed 11-17-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 72071
On April 1, 2013 (78 FR 19492), FDA SUMMARY: The Food and Drug comment, as well as any attachments,
announced the availability of a draft Administration (FDA) is announcing an except for information submitted,
version of this guidance. All comments opportunity for public comment on the marked and identified, as confidential,
received during the comment period for proposed collection of certain if submitted as detailed in
the draft guidance have been reviewed information by the Agency. Under the ‘‘Instructions.’’
and, where appropriate, incorporated Paperwork Reduction Act of 1995 (the Instructions: All submissions received
into this guidance. As a result of the PRA), Federal Agencies are required to must include the Docket No. FDA–
public comments, information has been publish notice in the Federal Register 2012–N–0921 for ‘‘Agency Information
added to provide clarity on the process concerning each proposed collection of Collection Activities; Proposed
for requesting meetings, including information, including each proposed Collection; Comment Request;
identifying the appropriate meeting extension of an existing collection of Electronic Submission of Food and Drug
type, and the data expectations to information, and to allow 60 days for Administration Adverse Event Reports
support the appropriate meeting type. public comment in response to the and Other Safety Information Using the
This guidance is being issued notice. This notice solicits comments on Electronic Submission Gateway and the
consistent with FDA’s good guidance the use of the FDA Electronic Safety Reporting Portal.’’ Received
practices regulation (21 CFR 10.115). Submission Gateway (ESG) and the comments will be placed in the docket
The guidance represents the current Safety Reporting Portal (SRP) to collect and, except for those submitted as
thinking of FDA on formal meetings adverse event reports and other safety ‘‘Confidential Submissions,’’ publicly
between FDA and biosimilar biological information for FDA-regulated products. viewable at http://www.regulations.gov
product sponsors or applicants. It does DATES: Submit either electronic or or at the Division of Dockets
not establish any rights for any person written comments on the collection of Management between 9 a.m. and 4 p.m.,
and is not binding on FDA or the public. information by January 19, 2016. Monday through Friday.
You can use an alternative approach if ADDRESSES: You may submit comments • Confidential Submissions—To
it satisfies the requirements of the as follows: submit a comment with confidential
applicable statutes and regulations. information that you do not wish to be
Electronic Submissions made publicly available, submit your
II. Paperwork Reduction Act of 1995
Submit electronic comments in the comments only as a written/paper
This guidance contains information following way: submission. You should submit two
collection provisions that are subject to • Federal eRulemaking Portal: http:// copies total. One copy will include the
review by the Office of Management and www.regulations.gov. Follow the information you claim to be confidential
Budget (OMB) under the Paperwork instructions for submitting comments. with a heading or cover note that states
Reduction Act of 1995 (44 U.S.C. 3501– Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS
3520). The collection of information in including attachments, to http:// CONFIDENTIAL INFORMATION’’. The
this guidance was approved under OMB www.regulations.gov will be posted to Agency will review this copy, including
control number 0910–0802. the docket unchanged. Because your the claimed confidential information, in
III. Electronic Access comment will be made public, you are its consideration of comments. The
solely responsible for ensuring that your second copy, which will have the
Persons with access to the Internet claimed confidential information
comment does not include any
may obtain the guidance at http:// redacted/blacked out, will be available
confidential information that you or a
www.fda.gov/Drugs/Guidance for public viewing and posted on
third party may not wish to be posted,
ComplianceRegulatoryInformation/ http://www.regulations.gov. Submit
such as medical information, your or
Guidances/default.htm, http:// both copies to the Division of Dockets
anyone else’s Social Security number, or
www.fda.gov/BiologicsBloodVaccines/ Management. If you do not wish your
confidential business information, such
GuidanceComplianceRegulatory name and contact information to be
as a manufacturing process. Please note
Information/default.htm, or http:// made publicly available, you can
that if you include your name, contact
www.regulations.gov. provide this information on the cover
information, or other information that
Dated: November 13, 2015. identifies you in the body of your sheet and not in the body of your
Leslie Kux, comments, that information will be comments and you must identify this
Associate Commissioner for Policy. posted on http://www.regulations.gov. information as ‘‘confidential.’’ Any
[FR Doc. 2015–29455 Filed 11–17–15; 8:45 am] • If you want to submit a comment information marked as ‘‘confidential’’
BILLING CODE 4164–01–P with confidential information that you will not be disclosed except in
do not wish to be made available to the accordance with 21 CFR 10.20 and other
public, submit the comment as a applicable disclosure law. For more
DEPARTMENT OF HEALTH AND written/paper submission and in the information about FDA’s posting of
HUMAN SERVICES manner detailed (see ‘‘Written/Paper comments to public dockets, see 80 FR
Submissions’’ and ‘‘Instructions’’). 56469, September 18, 2015, or access
Food and Drug Administration the information at: http://www.fda.gov/
Written/Paper Submissions regulatoryinformation/dockets/
[Docket No. FDA–2012–N–0921] Submit written/paper submissions as default.htm.
follows: Docket: For access to the docket to
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Agency Information Collection • Mail/Hand delivery/Courier (for read background documents or the
Activities; Proposed Collection; written/paper submissions): Division of electronic and written/paper comments
Comment Request; Adverse Event Dockets Management (HFA–305), Food received, go to http://
Reporting; Electronic Submissions and Drug Administration, 5630 Fishers www.regulations.gov and insert the
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
HHS. • For written/paper comments heading of this document, into the
submitted to the Division of Dockets ‘‘Search’’ box and follow the prompts
ACTION: Notice.
Management, FDA will post your and/or go to the Division of Dockets
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![72072 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
Management, 5630 Fishers Lane, Rm. reports, and other safety information for FD&C Act) by creating section 417 (21
1061, Rockville, MD 20852. FDA-regulated products. To ensure the U.S.C. 350f), Reportable Food Registry
FOR FURTHER INFORMATION CONTACT: FDA safety and identify any risks, harms, or (RFR or the Registry). Section 417 of the
PRA Staff, Office of Operations, Food other dangers to health for all FDA- FD&C Act defines ‘‘reportable food’’ as
and Drug Administration, 8455 regulated human and animal products, an ‘‘article of food (other than infant
Colesville Rd., COLE–14526, Silver the Agency needs to be informed formula or dietary supplements) for
Spring, MD 20993–0002, PRAStaff@ whenever an adverse event, product which there is a reasonable probability
fda.hhs.gov. quality problem, or product use error that the use of, or exposure to, such
occurs. This risk identification process article of food will cause serious adverse
SUPPLEMENTARY INFORMATION:
is the first necessary step that allows the health consequences or death to humans
I. Background Agency to gather the information or animals.’’ (See section 417(a)(2) of the
necessary to be able to evaluate the risk FD&C Act). The Secretary of Health and
Under the PRA (44 U.S.C. 3501–
associated with the product and take Human Services (the Secretary) has
3520), Federal Agencies must obtain
whatever action is necessary to mitigate delegated to the Commissioner of FDA
approval from the Office of Management
or eliminate the public’s exposure to the the responsibility for administering the
and Budget (OMB) for each collection of
risk. FD&C Act, including section 417. The
information they conduct or sponsor. Some adverse event reports are
‘‘Collection of information’’ is defined Congressionally identified purpose of
required to be submitted to FDA the RFR is to provide ‘‘a reliable
in 44 U.S.C. 3502(3) and 5 CFR (mandatory reporting) and some adverse
1320.3(c) and includes Agency requests mechanism to track patterns of
event reports are submitted voluntarily adulteration in food [which] would
or requirements that members of the (voluntary reporting). Requirements
public submit reports, keep records, or support efforts by the Food and Drug
regarding mandatory reporting of Administration to target limited
provide information to a third party. adverse events or product problems
Section 3506(c)(2)(A) of the PRA (44 inspection resources to protect the
have been codified in 21 CFR parts 310, public health’’ (121 Stat. 965). We
U.S.C. 3506(c)(2)(A)) requires Federal 314, 514, 600, 803 and 1271, specifically
Agencies to provide a 60-day notice in designed the RFR report rational
§§ 310.305, 314.80, 314.98, 314.540, questionnaire to enable FDA to quickly
the Federal Register concerning each 514.80, 600.80, 803.30, 803.40, 803.50,
proposed collection of information, identify, track, and remove from
803.53, 803.56 and 1271.350(a) (21 CFR commerce an article of food (other than
including each proposed extension of an 310.305, 314.80, 314.98, 314.540,
existing collection of information, infant formula and dietary supplements)
514.80, 600.80, 803.30, 803.40, 803.50, for which there is a reasonable
before submitting the collection to OMB 803.53, 803.56 and 1271.350(a)). While
for approval. To comply with this probability that the use of, or exposure
adverse event reports submitted to FDA to, such article of food will cause
requirement, FDA is publishing notice in paper format using Forms FDA 3500,
of the proposed collection of serious adverse health consequences or
3500A, 1932, and 1932a, are approved death to humans or animals. FDA’s
information set forth in this document. under OMB control numbers 0910–0284
With respect to the following Center for Food Safety and Applied
and 0910–0291, this notice solicits Nutrition (CFSAN) uses the information
collection of information, FDA invites comments on adverse event reports filed
comments on these topics: (1) Whether collected to help ensure that such
electronically via the SRP and the ESG, products are quickly and efficiently
the proposed collection of information and currently approved under OMB
is necessary for the proper performance removed from the market to prevent
control number 0910–0645. foodborne illnesses. The data elements
of FDA’s functions, including whether
the information will have practical III. The FDA Safety Reporting Portal for RFR reports remain unchanged in
utility; (2) the accuracy of FDA’s Rational Questionnaires this request for extension of OMB
estimate of the burden of the proposed FDA currently has OMB approval to approval.
collection of information, including the receive several types of adverse event B. Reports Concerning Experience With
validity of the methodology and reports electronically via the SRP using Approved New Animal Drugs
assumptions used; (3) ways to enhance rational questionnaires. In this notice,
the quality, utility, and clarity of the FDA seeks comments on the extension Section 512(l) of the FD&C Act (21
information to be collected; and (4) of OMB approval for the existing U.S.C. 360b(l)) and § 514.80(b) of FDA’s
ways to minimize the burden of the rational questionnaires; the proposed regulations (21 CFR 514.80) require
collection of information on revision of the existing rational applicants of approved new animal drug
respondents, including through the use questionnaire for dietary supplements; applications (NADAs) and approved
of automated collection techniques, the proposed revision of the existing abbreviated new animal drug
when appropriate, and other forms of rational questionnaire for tobacco applications (ANADAs) to report
information technology. products; a proposed new rational adverse drug experiences and product/
questionnaire that will be used for a manufacturing defects to the Center for
II. Electronic Submission of Food and Veterinary Medicine (CVM). This
Drug Administration Adverse Event new safety reporting program for
clinical trials and/or investigational use continuous monitoring of approved
Reports and Other Safety Information NADAs and ANADAs affords the
Using the Electronic Submission by the Center for Tobacco Products
(CTP); and proposed new rational primary means by which FDA obtains
Gateway and the Safety Reporting information regarding potential
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Portal—21 CFR 310.305, 314.80, 314.98, questionnaires that will be used for
food, infant formula, and cosmetic problems with the safety and efficacy of
314.540, 514.80, 600.80, 1271.350 and marketed approved new animal drugs as
Part 803—OMB Control Number 0910– adverse event reports.
well as potential product/manufacturing
0645—Revision A. Reportable Food Registry Reports problems. Postapproval marketing
The SRP and the ESG are the The Food and Drug Administration surveillance is important because data
Agency’s electronic systems for Amendments Act of 2007 (Pub. L. 110– previously submitted to FDA may no
collecting, submitting, and processing 85) (FDAAA) amended the Federal longer be adequate, as animal drug
adverse event reports, product problem Food, Drug, and Cosmetic Act (the effects can change over time and less
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![Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 72075
TABLE 2—NEW QUESTIONS ON THE PROPOSED FOOD, INFANT FORMULA, AND COSMETICS RATIONAL QUESTIONNAIRES
FOR BOTH SUSPECT AND CONCOMITANT PRODUCTS
Text of new question Is response mandatory or 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 information include all persons FDA via the ESG or the SRP regarding
Estimate submitting mandatory or voluntary FDA-regulated products.
Description of respondents: The adverse event reports electronically to FDA estimates the burden of this
respondents to this collection of collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Voluntary Adverse Event Report via the SRP (Other than
RFR Reports) ................................................................... 1,786 1 1,786 0.6 1,072
(36 minutes)
Mandatory Adverse Event Report via the SRP (Other than
RFR Reports) ................................................................... 636 1 636 1.0 636
Mandatory Adverse Event Report via the ESG (Gateway-
to-Gateway transmission) ................................................. 1,864,035 1 1,864,035 0.6 1,118,421
(36 minutes)
Mandatory and Voluntary RFR Reports via the SRP .......... 1,200 1 1,200 0.6 720
(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 and voluntary RFR reports must be Dated: November 12, 2015.
of respondents and the total annual submitted via the SRP. FDA estimates Leslie Kux,
responses in table 3, Estimated Annual that it will take a respondent 0.6 hour Associate Commissioner for Policy.
Reporting Burden, is based primarily on to submit a RFR report, whether the [FR Doc. 2015–29407 Filed 11–17–15; 8:45 am]
mandatory and voluntary adverse event submission is mandatory or voluntary.
BILLING CODE 4164–01–P
reports electronically submitted to the The burden hours required to
Agency. The estimated total annual complete paper FDA reporting forms
responses are based on initial reports. (Forms FDA 3500, 3500A, 1932, and
Followup reports, if any, are not 1932a) are reported under OMB control
counted as new reports. Based on its numbers 0910–0284 and 0910–0291.
experience with adverse event While FDA does not charge for the use
asabaliauskas on DSK5VPTVN1PROD with NOTICES
reporting, FDA estimates that it will of the ESG, FDA requires respondents to
take a respondent 0.6 hour to submit a obtain a public key infrastructure
voluntary adverse event report via the certificate in order to set up the account.
SRP, 1 hour to submit a mandatory This can be obtained in-house or
adverse event report via the SRP, and outsourced by purchasing a public key
0.6 hour to submit a mandatory adverse certificate that is valid for 1 year to 3
event report via the ESG (gateway-to- years. The certificate typically costs
gateway transmission). Both mandatory from $20 to $30.
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Document Created: 2018-03-01 11:19:42
Document Modified: 2018-03-01 11:19:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by January 19, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 72071 |
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