82 FR 6566 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6566-6568 | |
| FR Document | 2017-01187 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Notices] [Pages 6566-6568] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01187] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0084] Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network) 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 Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)). DATES: Submit either electronic or written comments on the collection of information by March 20, 2017. 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-2017-N-0084 for ``Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)).'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at [[Page 6567]] 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 Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: 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. Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))--OMB Control Number 0910-0471--Extension Under section 519 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i) authorizes FDA to require (1) manufacturers to report medical device-related deaths, serious injuries, and malfunctions; and (2) user facilities to report device-related deaths directly to manufacturers and FDA and serious injuries to the manufacturer. Section 213 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 519(b) of the FD&C Act relating to mandatory reporting by user facilities of deaths, serious injuries, and serious illnesses associated with the use of medical devices. This amendment legislated the replacement of universal user facility reporting by a system that is limited to a ``subset of user facilities that constitutes a representative profile of user reports'' for device-related deaths and serious injuries. This amendment is reflected in section 519(b)(5)(A) of the FD&C Act. This legislation provides FDA with the opportunity to design and implement a national surveillance network, composed of well-trained clinical facilities, to provide high-quality data on medical devices in clinical use. This system is called MedSun. FDA is seeking OMB clearance to continue to use electronic data collection to obtain the information on Form FDA 3500A (approved under OMB control number 0910-0291) related to medical devices and tissue products from the user facilities participating in MedSun, to obtain a demographic profile of the facilities, and for additional questions which will permit FDA to better understand the cause of reported adverse events. Participation in the program is voluntary and includes approximately 250 facilities. In addition to collecting data on the electronic adverse event report form, MedSun collects additional information from participating sites about reported problems emerging from the MedSun hospitals. This data collection is also voluntary and is collected on the same Web site as the report information. The burden estimate is based on the number of facilities participating in MedSun (250). FDA estimates an average of 15 reports per site annually. This estimate is based on MedSun working to promote reporting in general from the sites, as well as promoting reporting from specific parts of the hospitals, such as the pediatric intensive care units, the electrophysiology laboratories, and the hospital laboratories. FDA estimates 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Adverse event reporting................... 250 15 3,750 0.75 (45 minutes)....................... 2,813 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 6568]] Dated: January 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-01187 Filed 1-18-17; 8:45 am] BILLING CODE 4164-01-P
![6566 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices
2. Are there categories of genome voluntary premarket consultation public comment in response to the
edited plant varieties for which there process, foods from genome edited notice. This notice solicits comments on
are scientific bases to conclude that crops with modifications that could the Adverse Event Program for Medical
foods from such categories are unlikely have been achieved through traditional Devices (Medical Product Safety
to present food safety risks different breeding. Network (MedSun)).
from or greater than those for traditional 3. Are there categories of genome DATES: Submit either electronic or
plant breeding? Similarly, are there edited plant varieties for which there written comments on the collection of
categories of genome edited plant are scientific bases to conclude that information by March 20, 2017.
varieties for which the regulatory status foods from these categories are more ADDRESSES: You may submit comments
of the food derived from such plant likely than traditionally-bred plants to as follows:
varieties can be said to be no different present food safety risks? If so, please
from that of traditionally-bred plants? If describe the characteristics of these Electronic Submissions
there are such categories, is there a basis categories (including, for example, Submit electronic comments in the
upon which to determine that there information about the types of following way:
would be no reason to include them in phenotypes and modifications • Federal eRulemaking Portal: http://
any voluntary premarket consultation (insertions, deletions or substitutions) www.regulations.gov. Follow the
process? If so, please describe the achieved through genome editing) and instructions for submitting comments.
characteristics of such categories provide data and/or information to Comments submitted electronically,
(including, for example, information support why plant varieties in these including attachments, to http://
about the types of phenotypes and categories are more likely to present www.regulations.gov will be posted to
modifications (insertions, deletions or food safety risks than traditionally-bred the docket unchanged. Because your
substitutions) achieved through genome plants. comment will be made public, you are
editing) and provide data and/or 4. What steps can we take to help solely responsible for ensuring that your
information for why plant varieties in small firms, including those who may comment does not include any
these categories are unlikely to present be considering using genome editing to confidential information that you or a
food safety risks or regulatory status produce new plant varieties for use in
questions. Regulatory status questions third party may not wish to be posted,
human or animal food, to engage with such as medical information, your or
may include, for example, whether food FDA about any questions related to food
from the new plant variety contains an anyone else’s Social Security number, or
safety or the regulatory status of foods confidential business information, such
unapproved food or color additive such from their new plant varieties? Please
that premarket review and approval is as a manufacturing process. Please note
provide supporting data and other that if you include your name, contact
required (see sections 409 and 721 of information to support your comments
the FD&C Act). As another example, if information, or other information that
and responses to this question. identifies you in the body of your
food from the new plant variety has a
different nutritional profile from food Dated: January 11, 2017. comments, that information will be
from traditionally-bred plants, then Leslie Kux, posted on http://www.regulations.gov.
certain labeling may be required to Associate Commissioner for Policy. • If you want to submit a comment
disclose a material change in the food. [FR Doc. 2017–00840 Filed 1–18–17; 8:45 am] with confidential information that you
a. If such categories exist, how do BILLING CODE 4164–01–P
do not wish to be made available to the
plant developers ensure the safety of public, submit the comment as a
foods from new plant varieties in these written/paper submission and in the
categories? For example, how are safety DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
assessments of foods from these HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
varieties accomplished, and what data Written/Paper Submissions
and information are or should be Food and Drug Administration
considered in such assessments? Submit written/paper submissions as
[Docket No. FDA–2017–N–0084] follows:
b. If certain categories of genome
edited plants do not raise questions of • Mail/Hand delivery/Courier (for
Agency Information Collection
safety or regulatory status, should there written/paper submissions): Division of
Activities; Proposed Collection;
nevertheless be a mechanism separate Dockets Management (HFA–305), Food
Comment Request; Adverse Event
from the voluntary premarket and Drug Administration, 5630 Fishers
Program for Medical Devices (Medical
consultation process through which Lane, Rm. 1061, Rockville, MD 20852.
Product Safety Network)
plant developers may voluntarily notify • For written/paper comments
FDA about their intent to market a food AGENCY: Food and Drug Administration, submitted to the Division of Dockets
derived from a genome edited new plant HHS. Management, FDA will post your
variety that falls within these ACTION: Notice. comment, as well as any attachments,
categories? If so, what process should except for information submitted,
plant developers use to notify FDA? SUMMARY: The Food and Drug marked and identified, as confidential,
What kind of information should be Administration (FDA) is announcing an if submitted as detailed in
included in such a notification to FDA? opportunity for public comment on the ‘‘Instructions.’’
c. Given that genome editing proposed collection of certain Instructions: All submissions received
techniques can give rise to a broad range information by the Agency. Under the must include the Docket No. FDA–
mstockstill on DSK3G9T082PROD with NOTICES
of plant modifications, from simple gene Paperwork Reduction Act of 1995 (the 2017–N–0084 for ‘‘Adverse Event
deletions to totally novel genes, and that PRA), Federal Agencies are required to Program for Medical Devices (Medical
some such modifications can be publish notice in the Federal Register Product Safety Network (MedSun)).’’
achieved through traditional breeding, concerning each proposed collection of Received comments will be placed in
please discuss the basis upon which to information, including each proposed the docket and, except for those
determine that there would or would extension of an existing collection of submitted as ‘‘Confidential
not be a reason to include, in any information, and to allow 60 days for Submissions,’’ publicly viewable at
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![6568 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices
Dated: January 13, 2017. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Leslie Kux, https://www.regulations.gov. Follow the Agency will review this copy, including
Associate Commissioner for Policy. instructions for submitting comments. the claimed confidential information, in
[FR Doc. 2017–01187 Filed 1–18–17; 8:45 am] Comments submitted electronically, its consideration of comments. The
BILLING CODE 4164–01–P including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND comment will be made public, you are for public viewing and posted on
HUMAN SERVICES solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Division of Dockets
Food and Drug Administration confidential information that you or a Management. If you do not wish your
[Docket No. FDA–2016–D–1307] third party may not wish to be posted, name and contact information to be
such as medical information, your or made publicly available, you can
Drug and Device Manufacturer anyone else’s Social Security number, or provide this information on the cover
Communications With Payors, confidential business information, such sheet and not in the body of your
Formulary Committees, and Similar as a manufacturing process. Please note comments and you must identify this
Entities—Questions and Answers; that if you include your name, contact information as ‘‘confidential.’’ Any
Draft Guidance for Industry and information, or other information that information marked as ‘‘confidential’’
Review Staff; Availability identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
AGENCY: Food and Drug Administration, posted on https://www.regulations.gov. applicable disclosure law. For more
HHS. • If you want to submit a comment information about FDA’s posting of
ACTION: Notice of availability. with confidential information that you comments to public dockets, see 80 FR
do not wish to be made available to the 56469, September 18, 2015, or access
SUMMARY: The Food and Drug
public, submit the comment as a the information at: http://www.fda.gov/
Administration (FDA or Agency) is
written/paper submission and in the regulatoryinformation/dockets/
announcing the availability of a draft
manner detailed (see ‘‘Written/Paper default.htm.
guidance for industry and review staff
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
entitled ‘‘Drug and Device Manufacturer
Communications With Payors, Written/Paper Submissions read background documents or the
Formulary Committees, and Similar electronic and written/paper comments
Submit written/paper submissions as
Entities—Questions and Answers.’’ This received, go to https://
follows:
draft guidance provides answers to • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
common questions regarding the written/paper submissions): Division of docket number, found in brackets in the
communication of health care economic Dockets Management (HFA–305), Food heading of this document, into the
information (HCEI) about approved and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
prescription drugs by medical product Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
manufacturers, packers, distributers, • For written/paper comments Management, 5630 Fishers Lane, Rm.
and their representatives (firms) to submitted to the Division of Dockets 1061, Rockville, MD 20852.
payors, formulary committees, or other Management, FDA will post your Submit written requests for single
similar entities with knowledge and comment, as well as any attachments, copies of this draft guidance to the
expertise in the area of health care except for information submitted, Division of Drug Information, Center for
economic analysis (collectively referred marked and identified, as confidential, Drug Evaluation and Research, Food
to as payors). This draft guidance also if submitted as detailed in and Drug Administration, 10001 New
provides answers to common questions ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
about firms’ communications regarding Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
investigational drugs and devices must include the Docket No. FDA– 0002; the Office of Communication,
(investigational products) to payors 2016–D–1307 for ‘‘Drug and Device Outreach and Development, Center for
before FDA approval or clearance of Manufacturer Communications With Biologics Evaluation and Research,
such products. The Agency is issuing Payors, Formulary Committees, and Food and Drug Administration, 10903
this draft guidance to explain FDA’s Similar Entities—Questions and New Hampshire Ave., Bldg. 71, Rm.
current thinking on frequently asked Answers.’’ Received comments will be 3128, Silver Spring, MD 20993–0002;
questions regarding such placed in the docket and, except for the Office of the Center Director,
communications in order to provide those submitted as ‘‘Confidential Guidance and Policy Development,
clarity for firms and payors. Submissions,’’ publicly viewable at Center for Devices and Radiological
DATES: Although you can comment on https://www.regulations.gov or at the Health, Food and Drug Administration,
any guidance at any time (see 21 CFR Division of Dockets Management 10903 New Hampshire Ave., Bldg.66,
10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday Rm. 5431, Silver Spring, MD 20993–
considers your comment on this draft through Friday. 0002. Send one self-addressed adhesive
guidance before it begins work on the • Confidential Submissions—To label to assist that office in processing
final version of the guidance, submit submit a comment with confidential your requests. See the SUPPLEMENTARY
either electronic or written comments information that you do not wish to be INFORMATION section for electronic
mstockstill on DSK3G9T082PROD with NOTICES
on the draft guidance by April 19, 2017. made publicly available, submit your access to this draft guidance document.
ADDRESSES: You may submit comments comments only as a written/paper FOR FURTHER INFORMATION CONTACT:
as follows: submission. You should submit two Elaine Hu Cunningham, Center for Drug
copies total. One copy will include the Evaluation and Research, Food and
Electronic Submissions information you claim to be confidential Drug Administration, 10903 New
Submit electronic comments in the with a heading or cover note that states Hampshire Ave., Bldg. 51, Rm. 3203,
following way: ‘‘THIS DOCUMENT CONTAINS Silver Spring, MD 20993–0002, 301–
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Document Created: 2018-02-01 15:15:43
Document Modified: 2018-02-01 15:15:43
| 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 March 20, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 6566 |
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