80 FR 14138 - Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 52 (March 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 52 (March 18, 2015)
| Page Range | 14138-14139 | |
| FR Document | 2015-06118 |
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)] [Notices] [Pages 14138-14139] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06118] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0197] Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System 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 Emergency Shortages Data Collection System. DATES: Submit either electronic or written comments on the collection of information by May 18, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: 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, [[Page 14139]] when appropriate, and other forms of information technology. Emergency Shortages Data Collection System--Section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0491)-- (Extension) Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized to implement general powers (including conducting research) to carry out effectively the mission of FDA. Subsequent to the events of September 11, 2001, and as part of broader counterterrorism and emergency preparedness activities, FDA's Center for Devices and Radiological Health (CDRH) began developing operational plans and interventions that would enable CDRH to anticipate and respond to medical device shortages that might arise in the context of Federally declared disasters/emergencies or regulatory actions. In particular, CDRH identified the need to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand, and/or would be vulnerable to shortages in specific disaster/emergency situations or following specific regulatory actions. Such data could support prospective risk assessment, help inform risk mitigation strategies, and support real-time decision-making by the Department of Health and Human Services during actual emergencies or emergency preparedness exercises. FDA developed ``The Emergency Medical Device Shortages Program Survey'' in 2002 to support the acquisition of such data from medical device manufacturers. In 2004, CDRH changed the process for the data collection, and the electronic database in which the data were stored was formally renamed the ``Emergency Shortages Data Collection System'' (ESDCS). Recognizing that some of the data collected may be commercially confidential, access to the ESDCS is restricted to members of the CDRH Emergency Shortage Team (EST) and senior management with a need-to-know. At this time, the need-to-know senior management personnel are limited to two senior managers. Further, the data are used by this defined group only for decision making and planning in the context of a Federally declared disaster/emergency, an official emergency preparedness exercise, or a potential public health risk posed by non-disaster-related device shortage. The data procurement process consists of an initial scripted telephone call to a regulatory officer at a registered manufacturer of one or more key medical devices tracked in the ESDCS. In this initial call, the EST member describes the intent and goals of the data collection effort and makes the specific data request. After the initial call, one or more additional follow-up calls and/or electronic mail correspondence may be required to verify/validate data sent from the manufacturer, confirm receipt, and/or request additional detail. Although the regulatory officer is the agent who the EST member initially contacts, regulatory officers may designate an alternate representative within their organization to correspond subsequently with the CDRH EST member who is collecting or verifying/validating the data. Because of the dynamic nature of the medical device industry, particularly with respect to specific product lines, manufacturing capabilities, and raw material/subcomponent sourcing, it is necessary to update the data in the ESDCS at regular intervals. The EST makes such updates on a regular basis, but makes efforts to limit the frequency of outreach to a specific manufacturer to no more than every 4 months. The ESDCS will only include those medical devices for which there will likely be high demand during a specific emergency/disaster, or for which there are sufficiently small numbers of manufacturers such that disruption of manufacture or loss of one or more of these manufacturers would create a shortage. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden 1 ---------------------------------------------------------------------------------------------------------------- Number of Average Number of responses Total annual burden per Activity/FD&C act section respondents per responses response Total hours respondent (hours) ---------------------------------------------------------------------------------------------------------------- Emergency Shortages Data Collection System 125 3 375 0.5 188 (903(d)(2)).............................. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA based the burden estimates in table 1 of this document on past experience with direct contact with the medical device manufacturers and anticipated changes in the medical device manufacturing patterns for the specific devices being monitored. FDA estimates that approximately 125 manufacturers would be contacted by telephone and/or electronic mail 3 times per year either to obtain primary data or to verify/validate data. Because the requested data represent data elements that are monitored or tracked by manufacturers as part of routine inventory management activities, it is anticipated that for most manufacturers, the estimated time required of manufacturers to complete the data request will not exceed 30 minutes per request cycle. Dated: March 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06118 Filed 3-17-15; 8:45 am] BILLING CODE 4164-01-P
![14138 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued
First year
Number of Total Hours per Total
21 CFR Section frequency of
recordkeepers records record hours
recordkeeping
14 ...................... Controls to Prevent Adulteration From Microorga- 3 52 156 0.25 39
nisms 106.55(d), 106.100(e)(5)(ii), and
106.100(f)(7).
15 ...................... Controls to Prevent Adulteration During Packaging 1 12 12 0.25 3
and Labeling of Infant Formula 106.60(c).
16 ...................... General Quality Control—Testing 106.91(b)(1), 2 1 2 2 4
106.91(b)(2) and 106.91(b)(3).
17 ...................... General Quality Control 106.91(b)(1), 106.91(d), 2 52 104 0.15 15.6
and 106.100(e)(5)(i).
18 ...................... General Quality Control 106.91(b)(2) 106.91(d), 2 52 104 0.15 15.6
and 106.100(e)(5)(i).
19 ...................... General Quality Control 106.91(b)(3) 106.91(d), 2 52 104 0.15 15.6
and 106.100(e)(5)(i).
20 ...................... Audit Plans and Procedures 106.94—Ongoing re- 3 1 3 8 24
view and updating of Audits.
21 ...................... Audit Plans and Procedures 106.94—Regular Au- 3 52 156 4 624
dits.
Total Recurring Recordkeeping Burden ................... .......................... .......................... ................ ................ 6,328.06
Total Recordkeeping Burden ................................... .......................... .......................... ................ ................ 25,648.06
1 Asnoted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
2 As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
III. References information by the Agency. Under the information they conduct or sponsor.
The following references have been Paperwork Reduction Act of 1995 (the ‘‘Collection of information’’ is defined
placed on display in the Division of PRA), Federal Agencies are required to in 44 U.S.C. 3502(3) and 5 CFR
Dockets Management (HFA–305), Food publish notice in the Federal Register 1320.3(c) and includes Agency requests
and Drug Administration, 5630 Fishers concerning each proposed collection of or requirements that members of the
Lane, rm. 1061, Rockville, MD 20852, information, including each proposed public submit reports, keep records, or
and may be seen by interested persons extension of an existing collection of provide information to a third party.
between 9 a.m. and 4 p.m., Monday information, and to allow 60 days for Section 3506(c)(2)(A) of the PRA (44
through Friday. public comment in response to the U.S.C. 3506(c)(2)(A)) requires Federal
notice. This notice solicits comments on Agencies to provide a 60-day notice in
1. Zink, Don. Statement of Donald L. Zink, the Emergency Shortages Data
Ph.D.: Infant Formula Manufacturing the Federal Register concerning each
Collection System. proposed collection of information,
Practices, 2013.
DATES: Submit either electronic or including each proposed extension of an
Dated: March 12, 2015. written comments on the collection of existing collection of information,
Leslie Kux, information by May 18, 2015. before submitting the collection to OMB
Associate Commissioner for Policy. ADDRESSES: Submit electronic for approval. To comply with this
[FR Doc. 2015–06117 Filed 3–17–15; 8:45 am] comments on the collection of requirement, FDA is publishing notice
BILLING CODE 4164–01–P information to http:// of the proposed collection of
www.regulations.gov. Submit written
information set forth in this document.
comments on the collection of
DEPARTMENT OF HEALTH AND information to the Division of Dockets With respect to the following
HUMAN SERVICES Management (HFA–305), Food and Drug collection of information, FDA invites
Administration, 5630 Fishers Lane, Rm. comments on these topics: (1) Whether
Food and Drug Administration 1061, Rockville, MD 20852. All the proposed collection of information
[Docket No. FDA–2012–N–0197] comments should be identified with the is necessary for the proper performance
docket number found in brackets in the of FDA’s functions, including whether
Agency Information Collection heading of this document. the information will have practical
Activities; Proposed Collection; FOR FURTHER INFORMATION CONTACT: FDA utility; (2) the accuracy of FDA’s
Comment Request; Emergency PRA Staff, Office of Operations, Food estimate of the burden of the proposed
Shortages Data Collection System and Drug Administration, 8455 collection of information, including the
Colesville Rd., COLE–14526, Silver validity of the methodology and
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration,
Spring, MD 20993–0002, PRAStaff@ assumptions used; (3) ways to enhance
HHS.
fda.hhs.gov. the quality, utility, and clarity of the
ACTION: Notice.
SUPPLEMENTARY INFORMATION: Under the information to be collected; and (4)
SUMMARY: The Food and Drug PRA (44 U.S.C. 3501–3520), Federal ways to minimize the burden of the
Administration (FDA) is announcing an Agencies must obtain approval from the collection of information on
opportunity for public comment on the Office of Management and Budget respondents, including through the use
proposed collection of certain (OMB) for each collection of of automated collection techniques,
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![Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14139
when appropriate, and other forms of mitigation strategies, and support real- data collection effort and makes the
information technology. time decision-making by the specific data request. After the initial
Department of Health and Human call, one or more additional follow-up
Emergency Shortages Data Collection
Services during actual emergencies or calls and/or electronic mail
System—Section 903(d)(2) of the
emergency preparedness exercises. correspondence may be required to
Federal Food, Drug, and Cosmetic Act
FDA developed ‘‘The Emergency verify/validate data sent from the
(OMB Control Number 0910–0491)—
Medical Device Shortages Program manufacturer, confirm receipt, and/or
(Extension)
Survey’’ in 2002 to support the request additional detail. Although the
Under section 903(d)(2) of the Federal acquisition of such data from medical regulatory officer is the agent who the
Food, Drug, and Cosmetic Act (the device manufacturers. In 2004, CDRH EST member initially contacts,
FD&C Act) (21 U.S.C. 393(d)(2)), the changed the process for the data regulatory officers may designate an
Commissioner of Food and Drugs is collection, and the electronic database alternate representative within their
authorized to implement general powers in which the data were stored was organization to correspond subsequently
(including conducting research) to carry formally renamed the ‘‘Emergency with the CDRH EST member who is
out effectively the mission of FDA. Shortages Data Collection System’’ collecting or verifying/validating the
Subsequent to the events of September (ESDCS). Recognizing that some of the data.
11, 2001, and as part of broader data collected may be commercially Because of the dynamic nature of the
counterterrorism and emergency confidential, access to the ESDCS is medical device industry, particularly
preparedness activities, FDA’s Center restricted to members of the CDRH with respect to specific product lines,
for Devices and Radiological Health Emergency Shortage Team (EST) and manufacturing capabilities, and raw
(CDRH) began developing operational senior management with a need-to- material/subcomponent sourcing, it is
plans and interventions that would know. At this time, the need-to-know necessary to update the data in the
enable CDRH to anticipate and respond senior management personnel are ESDCS at regular intervals. The EST
to medical device shortages that might limited to two senior managers. Further, makes such updates on a regular basis,
arise in the context of Federally the data are used by this defined group but makes efforts to limit the frequency
declared disasters/emergencies or only for decision making and planning of outreach to a specific manufacturer to
regulatory actions. In particular, CDRH in the context of a Federally declared no more than every 4 months.
identified the need to acquire and disaster/emergency, an official The ESDCS will only include those
maintain detailed data on domestic emergency preparedness exercise, or a medical devices for which there will
inventory, manufacturing capabilities, potential public health risk posed by likely be high demand during a specific
distribution plans, and raw material non-disaster-related device shortage. emergency/disaster, or for which there
constraints for medical devices that The data procurement process are sufficiently small numbers of
would be in high demand, and/or would consists of an initial scripted telephone manufacturers such that disruption of
be vulnerable to shortages in specific call to a regulatory officer at a registered manufacture or loss of one or more of
disaster/emergency situations or manufacturer of one or more key these manufacturers would create a
following specific regulatory actions. medical devices tracked in the ESDCS. shortage.
Such data could support prospective In this initial call, the EST member FDA estimates the burden of this
risk assessment, help inform risk describes the intent and goals of the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual burden per
Activity/FD&C act section Total hours
respondents per responses response
respondent (hours)
Emergency Shortages Data Collection System (903(d)(2)) .................... 125 3 375 0.5 188
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in request will not exceed 30 minutes per DEPARTMENT OF HEALTH AND
table 1 of this document on past request cycle. HUMAN SERVICES
experience with direct contact with the Dated: March 12, 2015.
medical device manufacturers and Food and Drug Administration
Leslie Kux,
anticipated changes in the medical
device manufacturing patterns for the Associate Commissioner for Policy. [Docket No. FDA–2015–N–0001]
specific devices being monitored. FDA [FR Doc. 2015–06118 Filed 3–17–15; 8:45 am]
estimates that approximately 125 BILLING CODE 4164–01–P
Cardiovascular and Renal Drugs
manufacturers would be contacted by Advisory Committee; Amendment of
Notice
telephone and/or electronic mail 3 times
per year either to obtain primary data or AGENCY: Food and Drug Administration,
mstockstill on DSK4VPTVN1PROD with NOTICES
to verify/validate data. Because the HHS.
requested data represent data elements ACTION: Notice.
that are monitored or tracked by
manufacturers as part of routine SUMMARY: The Food and Drug
inventory management activities, it is Administration (FDA) is announcing an
anticipated that for most manufacturers, amendment to the notice of meeting of
the estimated time required of the Cardiovascular and Renal Drugs
manufacturers to complete the data Advisory Committee. This meeting was
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Document Created: 2018-02-21 09:39:52
Document Modified: 2018-02-21 09:39:52
| 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 May 18, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 14138 |
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