81 FR 10252 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting; Electronic Submissions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 39 (February 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 39 (February 29, 2016)
| Page Range | 10252-10256 | |
| FR Document | 2016-04223 |
[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)] [Notices] [Pages 10252-10256] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. 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
![10252 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices
complex chemistry, manufacturing, II. Electronic Submission of Food and rational questionnaire for tobacco
efficacy, and/or safety issues, the Drug Administration Adverse Event products; a proposed new rational
estimated time requirement per file is Reports and Other Safety Information questionnaire that will be used for a
approximately 5,000 hours. We estimate Using the Electronic Submission new safety reporting program for
that, annually, 5 respondents will each Gateway and the Safety Reporting clinical trials and/or investigational use
submit 1 such file, for a total of 25,000 Portal—21 CFR 310.305, 314.80, 314.98, by the Center for Tobacco Products
hours. 314.540, 514.80, 600.80, 1271.350 and (CTP); and proposed new rational
Dated: February 23, 2016. Part 803 (OMB Control Number 0910— questionnaires that will be used for
0645)—Revision food, infant formula, and cosmetic
Leslie Kux,
adverse event reports.
Associate Commissioner for Policy. The Safety Reporting Portal (SRP) and
[FR Doc. 2016–04228 Filed 2–26–16; 8:45 am] the Electronic Submission Gateway A. Reportable Food Registry Reports
BILLING CODE 4164–01–P
(ESG) are the Agency’s electronic The Food and Drug Administration
systems for collecting, submitting, and Amendments Act of 2007 (Pub. L. 110–
processing adverse event reports, 085) (FDAAA) amended the Federal
DEPARTMENT OF HEALTH AND product problem reports, and other Food, Drug, and Cosmetic Act (the
HUMAN SERVICES safety information for FDA-regulated FD&C Act) by creating section 417 (21
products. To ensure the safety and U.S.C. 350f), Reportable Food Registry
Food and Drug Administration identify any risks, harms, or other (RFR or the Registry). Section 417 of the
dangers to health for all FDA-regulated FD&C Act defines ‘‘reportable food’’ as
[Docket No. FDA–2012–N–0921] human and animal products, the an ‘‘article of food (other than infant
Agency needs to be informed whenever formula or dietary supplements) for
Agency Information Collection an adverse event, product quality which there is a reasonable probability
Activities; Submission for Office of problem, or product use error occurs. that the use of, or exposure to, such
Management and Budget Review; This risk identification process is the article of food will cause serious adverse
Comment Request; Adverse Event first necessary step that allows the health consequences or death to humans
Reporting; Electronic Submissions 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
AGENCY: Food and Drug Administration, associated with the product and take Human Services (the Secretary) has
HHS. whatever action is necessary to mitigate delegated to the Commissioner of FDA
ACTION: Notice. or eliminate the public’s exposure to the the responsibility for administering the
risk. FD&C Act, including section 417. The
SUMMARY: The Food and Drug Some adverse event reports are Congressionally identified purpose of
Administration (FDA) is announcing required to be submitted to FDA the RFR is to provide ‘‘a reliable
that a proposed collection of (mandatory reporting) and some adverse mechanism to track patterns of
information has been submitted to the event reports are submitted voluntarily adulteration in food [which] would
Office of Management and Budget (voluntary reporting). Requirements support efforts by the Food and Drug
(OMB) for review and clearance under regarding mandatory reporting of Administration to target limited
the Paperwork Reduction Act of 1995. adverse events or product problems inspection resources to protect the
DATES: Fax written comments on the have been codified in 21 CFR parts 310, public health’’ (121 Stat. 965). We
collection of information by March 30, 314, 514, 600, 803 and 1271, specifically designed the RFR report rational
2016. §§ 310.305, 314.80, 314.98, 314.540, questionnaire to enable FDA to quickly
ADDRESSES: To ensure that comments on 514.80, 600.80, 803.30, 803.40, 803.50, identify, track, and remove from
the information collection are received, 803.53, 803.56, and 1271.350(a) (21 CFR commerce an article of food (other than
OMB recommends that written 310.305, 314.80, 314.98, 314.540, infant formula and dietary supplements)
comments be faxed to the Office of 514.80, 600.80, 803.30, 803.40, 803.50, for which there is a reasonable
Information and Regulatory Affairs, 803.53, 803.56, and 1271.350(a)). While probability that the use of, or exposure
OMB, Attn: FDA Desk Officer, FAX: adverse event reports submitted to FDA to, such article of food will cause
202–395–7285, or emailed to oira_ in paper format using Forms FDA 3500, serious adverse health consequences or
submission@omb.eop.gov. All 3500A, 1932, and 1932a, are approved death to humans or animals. FDA’s
comments should be identified with the under OMB control numbers 0910–0284 Center for Food Safety and Applied
OMB control number 0910–0645. Also and 0910–0291, this notice solicits Nutrition (CFSAN) uses the information
include the FDA docket number found comments on adverse event reports filed collected to help ensure that such
in brackets in the heading of this electronically via the SRP and the ESG, products are quickly and efficiently
document. and currently approved under OMB removed from the market to prevent
control number 0910–0645. foodborne illnesses. The data elements
FOR FURTHER INFORMATION CONTACT: FDA
III. The FDA Safety Reporting Portal for RFR reports remain unchanged in
PRA Staff, Office of Operations, Food
Rational Questionnaires this request for extension of OMB
and Drug Administration, 8455
approval.
Colesville Rd., COLE–14526, Silver FDA currently has OMB approval to
Spring, MD 20993–0002, PRAStaff@ receive several types of adverse event B. Reports Concerning Experience With
asabaliauskas on DSK5VPTVN1PROD with NOTICES
fda.hhs.gov. reports electronically via the SRP using Approved New Animal Drugs
SUPPLEMENTARY INFORMATION: rational questionnaires. In this notice, Section 512(l) of the FD&C Act (21
FDA seeks comments on the extension U.S.C. 360b(l)) and § 514.80(b) of FDA’s
I. Background of OMB approval for the existing regulations (21 CFR 514.80) require
In compliance with 44 U.S.C. 3507, rational questionnaires; the proposed applicants of approved new animal drug
FDA has submitted the following revision of the existing rational applications (NADAs) and approved
proposed collection of information to questionnaire for dietary supplements; abbreviated new animal drug
OMB for review and clearance. the proposed revision of the existing applications (ANADAs) to report
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![10256 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices
This can be obtained in-house or Dated: February 23, 2016. comments, that information will be
outsourced by purchasing a public key Leslie Kux, posted on http://www.regulations.gov.
certificate that is valid for 1 year to 3 Associate Commissioner for Policy. • If you want to submit a comment
years. The certificate typically costs [FR Doc. 2016–04277 Filed 2–26–16; 8:45 am] with confidential information that you
from $20 to $30. BILLING CODE 4164–01–P
do not wish to be made available to the
Dated: February 23, 2016.
public, submit the comment as a
written/paper submission and in the
Leslie Kux,
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
Associate Commissioner for Policy. Submissions’’ and ‘‘Instructions’’).
HUMAN SERVICES
[FR Doc. 2016–04223 Filed 2–26–16; 8:45 am]
BILLING CODE 4164–01–P
Written/Paper Submissions
Food and Drug Administration
Submit written/paper submissions as
[Docket No. FDA–2016–N–0586] follows:
DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for
HUMAN SERVICES Draft Food and Drug Administration written/paper submissions): Division of
Tribal Consultation Policy; Availability; Dockets Management (HFA–305), Food
Food and Drug Administration Request for Comments and Drug Administration, 5630 Fishers
[Docket No. FDA–2015–N–2126] Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration,
• For written/paper comments
HHS.
Agency Information Collection submitted to the Division of Dockets
Activities; Announcement of Office of ACTION:Notice of availability; request Management, FDA will post your
Management and Budget Approval; for comments. comment, as well as any attachments,
Food and Drug Administration’s except for information submitted,
SUMMARY: The Food and Drug
Research and Evaluation Survey for marked and identified, as confidential,
Administration (FDA or we) is
the Public Education Campaign on if submitted as detailed in
announcing the availability of the draft
Tobacco Among LGBT (RESPECT) ‘‘Instructions.’’
FDA Tribal Consultation Policy. We are Instructions: All submissions received
AGENCY: Food and Drug Administration, also announcing the establishment of a must include the Docket No. FDA–
HHS. docket to receive comments on the draft 2016–N–0586 for ‘‘Draft FDA Tribal
ACTION: Notice. FDA Tribal Consultation Policy. The Consultation Policy; Availability;
purpose of the FDA Tribal Consultation Request for Comments.’’ Received
SUMMARY: The Food and Drug Policy, when finalized, is to establish comments will be placed in the docket
Administration (FDA) is announcing clear policies to further the government- and, except for those submitted as
that a collection of information entitled to-government relationship between ‘‘Confidential Submissions,’’ publicly
‘‘Food and Drug Administration’s FDA and American Indian and Alaskan viewable at http://www.regulations.gov
Research and Evaluation Survey for the Native Tribes (hereafter, Indian Tribes) or at the Division of Dockets
Public Education Campaign on Tobacco and facilitate tribal consultation with Management between 9 a.m. and 4 p.m.,
among LGBT (RESPECT)’’ has been FDA. The draft FDA Tribal Consultation Monday through Friday.
approved by the Office of Management Policy provides background on FDA’s • Confidential Submissions—To
and Budget (OMB) under the Paperwork mission and organizational structure submit a comment with confidential
Reduction Act of 1995. and sets out principles and guidelines information that you do not wish to be
FOR FURTHER INFORMATION CONTACT: FDA for the tribal consultation process. made publicly available, submit your
PRA Staff, Office of Operations, Food DATES: Comments must be received on comments only as a written/paper
and Drug Administration, 8455 or before May 31, 2016. submission. You should submit two
Colesville Rd., COLE–14526, Silver ADDRESSES: You may submit comments copies total. One copy will include the
Spring, MD 20993–0002, PRAStaff@ as follows: information you claim to be confidential
fda.hhs.gov. with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
SUPPLEMENTARY INFORMATION: On
January 26, 2016, the Agency submitted Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
a proposed collection of information following way: Agency will review this copy, including
entitled ‘‘Food and Drug • Federal eRulemaking Portal: http:// the claimed confidential information, in
Administration’s Research and www.regulations.gov. Follow the its consideration of comments. The
Evaluation Survey for the Public instructions for submitting comments. second copy, which will have the
Education Campaign on Tobacco among Comments submitted electronically, claimed confidential information
LGBT (RESPECT)’’ to OMB for review including attachments, to http:// redacted/blacked out, will be available
and clearance under 44 U.S.C. 3507. An www.regulations.gov will be posted to for public viewing and posted on
Agency may not conduct or sponsor, the docket unchanged. Because your http://www.regulations.gov. Submit
and a person is not required to respond comment will be made public, you are both copies to the Division of Dockets
to, a collection of information unless it solely responsible for ensuring that your Management. If you do not wish your
displays a currently valid OMB control comment does not include any name and contact information to be
number. OMB has now approved the confidential information that you or a made publicly available, you can
asabaliauskas on DSK5VPTVN1PROD with NOTICES
information collection and has assigned third party may not wish to be posted, provide this information on the cover
OMB control number 0910–0808. The such as medical information, your or sheet and not in the body of your
approval expires on January 31, 2019. A anyone else’s Social Security number, or comments and you must identify this
copy of the supporting statement for this confidential business information, such information as ‘‘confidential.’’ Any
information collection is available on as a manufacturing process. Please note information marked as ‘‘confidential’’
the Internet at http://www.reginfo.gov/ that if you include your name, contact will not be disclosed except in
public/do/PRAMain. information, or other information that accordance with 21 CFR 10.20 and other
April 4, 2016 identifies you in the body of your applicable disclosure law. For more
VerDate Sep<11>2014 19:23 Feb 26, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\29FEN1.SGM 29FEN1](https://thefederalregister.org/doc/81_FR_10291/page/5.svg)
Document Created: 2016-02-27 02:05:24
Document Modified: 2016-02-27 02:05:24
| 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 | Fax written comments on the collection of information by March 30, 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 | 81 FR 10252 |
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