83 FR 61653 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Adverse Event Reports; Electronic Submissions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61653-61657 | |
| FR Document | 2018-26031 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61653-61657] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26031] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4131] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Adverse Event Reports; Electronic Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on 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 29, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 29, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-4131 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Adverse Event Reports; Electronic Submissions.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [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. [[Page 61654]] 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. FDA Adverse Event Reports; Electronic Submissions--21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 1271.350, and Part 803 OMB Control Number 0910-0645--Extension 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. [thinsp]310.305, 314.80, 314.98, 314.540, 329.100, 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, 329.100, 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. II. 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 these existing rational questionnaires and the proposed revision of the existing rational questionnaire for tobacco products. 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 (FD&C Act) by creating section 417 (21 U.S.C. 350f), Reportable Food Registry (RFR). Section 417 of the FD&C Act defines ``reportable food'' as an article of food (other than infant formula) 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 FDA Commissioner the responsibility for administering the FD&C Act, including section 417. The purpose of the RFR is to enable the Agency to track patterns of adulteration in food to support its efforts to target limited inspection resources to protect the public health. 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. [thinsp]514.80(b) of FDA's regulations 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 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. [thinsp]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 FDAAA directed the Secretary to establish an early warning and surveillance system to [[Page 61655]] 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 a revision to the existing rational questionnaire utilized by consumers and concerned citizens to report tobacco product adverse event or product problems. 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 (Pub. L. 111-31) 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 authorizes FDA to establish regulations with respect to mandatory adverse event reports associated with the use of a tobacco product. FDA collects voluntary adverse event reports associated with the use of tobacco products from interested parties such as healthcare providers, researchers, consumers, and other users of tobacco products. Information collected in voluntary adverse event reports contributes to the Center for Tobacco Product's (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. FDA's 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 SRP 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. We are revising the questionnaire with non- substantive changes. The changes are made 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 to include values more pertinent to CTP's current and future data collection needs. In one instance, a question was added about the event location: ``In what setting(s) did this problem occur?'' In still other instances, questions were removed altogether 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. CTP has two voluntary rational questionnaires on the SRP. The first is utilized by consumers and concerned citizens to report tobacco product adverse event or product problems. A second rational questionnaire is used by tobacco product investigators in clinical trials with investigational tobacco products. In addition to the information collected by the first rational questionnaire for tobacco products, the second rational questionnaire collects 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 capture tobacco-specific adverse event and product problem information from reporting entities such as healthcare 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. FDA uses tobacco-specific adverse event and product problem information to assess and evaluate the risk associated with the product and to take whatever action is necessary to reduce, mitigate, or eliminate the public's exposure to the risk through regulatory and public health interventions. The burden for CTP remains unchanged. We seek approval of the revised rational questionnaire in this request for extension of OMB approval. 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 [[Page 61656]] 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. 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 March 2016. 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. The electronic submission data elements to report adverse events associated with dietary supplement products remain unchanged in this request for extension of OMB approval. F. Food, Infant Formula, and Cosmetic Adverse Event Reports We continue to work on proposed new rational questionnaire functionality that will be used for food, infant formula, and cosmetic adverse event reports over the SRP. 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. The electronic submission data elements to report adverse events associated with food, infant formula, and cosmetics products remain unchanged in this request for extension of OMB approval. III. 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. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Voluntary Adverse Event Report via the SRP 1,800 1 1,800 0.6 (36 minutes)......................... 1,080 (Other than RFR Reports). Mandatory Adverse Event Report via the SRP 3,360 1 3,360 1........................................ 3,360 (Other than RFR Reports). Mandatory Adverse Event Report via the ESG 3,007,000 1 3,007,000 0.6 (36 minutes)......................... 1,804,200 (Gateway-to-Gateway transmission). Mandatory and Voluntary RFR Reports via the 1,260 1 1,260 0.6 (36 minutes)......................... 756 SRP. ---------------------------------------------------------------------------------------------------------- Total.................................... .............. .............. 3,013,420 ......................................... 1,809,396 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 1 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. [[Page 61657]] 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, the Agency requires respondents to obtain a public key infrastructure certificate 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. Our estimated burden for the information collection reflects an overall increase of 688,547 hours and a corresponding increase of 1,145,763 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Dated: November 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26031 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
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CONTACT) at least 7 days in advance of Comments received by mail/hand • Confidential Submissions—To
the meeting. delivery/courier (for written/paper submit a comment with confidential
FDA is committed to the orderly submissions) will be considered timely information that you do not wish to be
conduct of its advisory committee if they are postmarked or the delivery made publicly available, submit your
meetings. Please visit our website at service acceptance receipt is on or comments only as a written/paper
https://www.fda.gov/Advisory before that date. submission. You should submit two
Committees/AboutAdvisoryCommittees/ copies total. One copy will include the
ucm111462.htm for procedures on Electronic Submissions
information you claim to be confidential
public conduct during advisory Submit electronic comments in the with a heading or cover note that states
committee meetings. following way: ‘‘THIS DOCUMENT CONTAINS
Notice of this meeting is given under • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
the Federal Advisory Committee Act (5 https://www.regulations.gov. Follow the Agency will review this copy, including
U.S.C. app. 2). instructions for submitting comments. the claimed confidential information, in
Dated: November 26, 2018.
Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
Leslie Kux,
www.regulations.gov will be posted to claimed confidential information
Associate Commissioner for Policy. the docket unchanged. Because your redacted/blacked out, will be available
[FR Doc. 2018–25991 Filed 11–29–18; 8:45 am] comment will be made public, you are for public viewing and posted on
BILLING CODE 4164–01–P solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND third party may not wish to be posted,
HUMAN SERVICES contact information to be made publicly
such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Food and Drug Administration
confidential business information, such in the body of your comments and you
[Docket No. FDA–2018–N–4131] as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
Agency Information Collection information, or other information that
Activities; Proposed Collection; as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
Comment Request; Food and Drug comments, that information will be
Administration Adverse Event Reports; and other applicable disclosure law. For
posted on https://www.regulations.gov. more information about FDA’s posting
Electronic Submissions • If you want to submit a comment of comments to public dockets, see 80
AGENCY: Food and Drug Administration, with confidential information that you FR 56469, September 18, 2015, or access
HHS. do not wish to be made available to the the information at: https://www.gpo.gov/
ACTION: Notice. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Administration (FDA, Agency, or we) is Submissions’’ and ‘‘Instructions’’). read background documents or the
announcing an opportunity for public Written/Paper Submissions electronic and written/paper comments
comment on the proposed collection of received, go to https://
certain information by the Agency. Submit written/paper submissions as
www.regulations.gov and insert the
Under the Paperwork Reduction Act of follows:
• Mail/Hand Delivery/Courier (for docket number, found in brackets in the
1995 (PRA), Federal Agencies are heading of this document, into the
required to publish notice in the written/paper submissions): Dockets
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
Federal Register concerning each and/or go to the Dockets Management
proposed collection of information, Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
including each proposed extension of an Rockville, MD 20852.
• For written/paper comments
existing collection of information, and FOR FURTHER INFORMATION CONTACT:
submitted to the Dockets Management
to allow 60 days for public comment in Domini Bean, Office of Operations,
Staff, FDA will post your comment, as
response to the notice. This notice Food and Drug Administration, Three
well as any attachments, except for
solicits comments on the use of the FDA White Flint North, 10A–12M, 11601
information submitted, marked and
Electronic Submission Gateway (ESG) Landsdown St., North Bethesda, MD
identified, as confidential, if submitted
and the Safety Reporting Portal (SRP) to 20852, 301–796–5733, PRAStaff@
as detailed in ‘‘Instructions.’’
collect adverse event reports and other fda.hhs.gov.
Instructions: All submissions received
safety information for FDA-regulated
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION:
products.
2018–N–4131 for ‘‘Agency Information
DATES: Submit either electronic or Collection Activities; Proposed I. Background
written comments on the collection of Collection; Comment Request; FDA Under the PRA (44 U.S.C. 3501–
information by January 29, 2019. Adverse Event Reports; Electronic 3520), Federal Agencies must obtain
ADDRESSES: You may submit comments Submissions.’’ Received comments, approval from the Office of Management
as follows. Please note that late, those filed in a timely manner (see and Budget (OMB) for each collection of
amozie on DSK3GDR082PROD with NOTICES1
untimely filed comments will not be ADDRESSES), will be placed in the docket information they conduct or sponsor.
considered. Electronic comments must and, except for those submitted as ‘‘Collection of information’’ is defined
be submitted on or before January 29, ‘‘Confidential Submissions,’’ publicly in 44 U.S.C. 3502(3) and 5 CFR
2019. The https://www.regulations.gov viewable at https://www.regulations.gov 1320.3(c) and includes Agency requests
electronic filing system will accept or at the Dockets Management Staff or requirements that members of the
comments until 11:59 p.m. Eastern Time between 9 a.m. and 4 p.m., Monday public submit reports, keep records, or
at the end of January 29, 2019. through Friday. provide information to a third party.
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The burden hours required to Participants should call and connect 15 number listed above at least 3 business
complete paper FDA reporting forms minutes before the meeting starts for days before the meeting.
(Forms FDA 3500, 3500A, 1932, and logistics to be set up. If you have never Amy P. McNulty,
1932a) are reported under OMB control attended an Adobe Connect meeting,
numbers 0910–0284 and 0910–0291. Acting Director, Division of the Executive
please test your connection using the Secretariat.
While FDA does not charge for the use following URL: https://
of the ESG, the Agency requires [FR Doc. 2018–26080 Filed 11–29–18; 8:45 am]
hrsa.connectsolutions.com/common/
respondents to obtain a public key help/en/support/meeting_test.htm Get a
BILLING CODE 4165–15–P
infrastructure certificate to set up the quick overview at the following URL:
account. This can be obtained in-house http://www.adobe.com/go/connectpro_
or outsourced by purchasing a public DEPARTMENT OF HEALTH AND
overview. HUMAN SERVICES
key certificate that is valid for 1 year to
3 years. The certificate typically costs FOR FURTHER INFORMATION CONTACT: Meetings Announcement for the
from $20 to $30. Annie Herzog, Program Analyst, Physician-Focused Payment Model
Our estimated burden for the Division of Injury Compensation Technical Advisory Committee
information collection reflects an Programs (DICP), HRSA, 5600 Fishers Required by the Medicare Access and
overall increase of 688,547 hours and a Lane, 08N146B, Rockville, Maryland CHIP Reauthorization Act of 2015
corresponding increase of 1,145,763
20857; 301–443–6593; or aherzog@ (MACRA); Correction
responses. We attribute this adjustment
hrsa.gov.
to an increase in the number of ACTION: Notice of public meetings;
submissions we received over the last SUPPLEMENTARY INFORMATION: The ACCV correction.
few years. was established by section 2119 of the
Dated: November 26, 2018. Public Health Service (PHS) Act (42 SUMMARY: The Department of Health and
Leslie Kux, U.S.C. 300aa–19), as enacted by Public Human Services published a document
Law (Pub. L.) 99–660, and as in the Federal Register of February 05,
Associate Commissioner for Policy.
2018 detailing the 2018 PTAC meeting
[FR Doc. 2018–26031 Filed 11–29–18; 8:45 am] subsequently amended, and advises the
dates and the link that connects to the
BILLING CODE 4164–01–P Secretary of HHS (the Secretary) on
meeting registration website. The
issues related to implementation of the
December meeting date has been
National Vaccine Injury Compensation shortened to a one day meeting and the
DEPARTMENT OF HEALTH AND Program (VICP). During the December 6, registration link has been updated.
HUMAN SERVICES 2018, meeting, agenda items will
FOR FURTHER INFORMATION CONTACT:
include, but are not limited to, updates
Health Resources and Services Sarah Selenich, Designated Federal
from the DICP, Department of Justice Official, at the Office of Health Policy,
Administration
(DOJ), National Vaccine Program Office Assistant Secretary for Planning and
Meeting of the Advisory Commission (NVPO), Immunization Safety Office Evaluation, U.S. Department of Health
on Childhood Vaccines (Centers for Disease Control and and Human Services, 200 Independence
Prevention), National Institute of Ave. SW, Washington, DC 20201, (202)
AGENCY: Health Resources and Services Allergy and Infectious Diseases
Administration (HRSA), Department of 690–6870.
(National Institutes of Health) and SUPPLEMENTARY INFORMATION:
Health and Human Services (HHS).
Center for Biologics, Evaluation and
ACTION: Notice. Correction
Research (Food and Drug
SUMMARY: The Advisory Commission on Administration). Agenda items are In the Federal Register of February 5,
Childhood Vaccines (ACCV) has subject to change as priorities dictate. 2018, in FR Doc. 2018–02211, on page
scheduled a public meeting. Information Refer to the ACCV website listed above 5109, in the first column, correct the
about the ACCV and the agenda for this for any updated information concerning ‘‘Dates’’ caption to read:
meeting can be found on the ACCV the meeting to include a draft agenda DATES: The 2018 PTAC meetings will
website at: http://www.hrsa.gov/ and additional meeting materials that occur on the following dates:
advisorycommittees/childhoodvaccines/ will be posted before the meeting. • Monday–Tuesday, March 26–27,
index.html. This notice is being Members of the public will have the 2018, from 9:00 a.m. to 5:00 p.m. ET
published less than 15 days prior to the opportunity to provide comments. • Thursday–Friday, June 14–15, 2018,
meeting date due to unexpected from 9:00 a.m. to 5:00 p.m. ET
Public participants may submit written
administrative delays. • Thursday–Friday, September 6–7,
statements in advance of the scheduled
DATES: December 6, 2018, at 10:00 a.m. 2018, from 9:00 a.m. to 5:00 p.m. ET
meeting. Oral comments will be
ET.
honored in the order they are requested • Monday, December 10, 2018, from
ADDRESSES: This meeting will be held 12:30 p.m. to 5:00 p.m. ET
and may be limited as time allows.
by teleconference and Adobe Connect Requests to submit a written statement Please note that times are subject to
webinar. The public can join the change. If the times change, registrants
or make oral comments to the ACCV
meeting by: will be notified directly via email.
1. (Audio Portion) Calling the should be sent to Annie Herzog using
conference phone number 800–988– the contact information above by Correction
amozie on DSK3GDR082PROD with NOTICES1
0218 and providing the following Wednesday, December 5, 2018. In the Federal Register of February 5,
information: Leader Name: Dr. Narayan Individuals who need special 2018, in FR Doc. 2018–02211, on page
Nair, Password: 9302948. assistance or another reasonable 5109, in the second column, correct the
2. (Visual Portion) Connect to the accommodation should notify Annie ‘‘Meeting Registration’’ caption to read:
ACCV Adobe Connect Meeting using the Herzog at the address and phone Meeting Registration:
following URL: https:// The public may attend the meetings
hrsa.connectsolutions.com/accv/. in-person or participate by phone via
VerDate Sep<11>2014 17:00 Nov 29, 2018 Jkt 247001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1](https://thefederalregister.org/doc/83_FR_61884/page/5.svg)
Document Created: 2018-11-30 04:35:46
Document Modified: 2018-11-30 04:35:46
| 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 29, 2019. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 61653 |
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