82 FR 44422 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 183 (September 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 183 (September 22, 2017)
| Page Range | 44422-44424 | |
| FR Document | 2017-20283 |
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)] [Notices] [Pages 44422-44424] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20283] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0501] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food 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 October 23, 2017. 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 0910-0643. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Third Party Disclosure and Recordkeeping Requirements for Reportable Food--21 U.S.C. 350f OMB Control Number 0910-0643--Extension The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), requires the establishment of a Reportable Food Registry (the Registry) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. Section 417 of the FD&C Act (21 U.S.C. 350f) 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.'' (Section 417(a)(2) of the FD&C Act.) We believe that the most efficient and cost effective means to implement the Registry is by utilizing our electronic Safety Reporting Portal. The information collection provisions associated with the submission of reportable food reports has been approved under OMB control number 0910-0643. In conjunction with the reportable foods requirements, section 417 of the FD&C Act also establishes third party disclosure and recordkeeping burdens. Specifically, we may require the responsible party to notify the immediate previous source(s) and/or immediate subsequent recipient(s) of a reportable food (section 417(d)(6)(B)(i) to (ii) of the FD&C Act). Similarly, we may also require the responsible party that is notified (i.e., the immediate previous source and/or immediate subsequent recipient) to notify their own immediate previous source(s) and/or immediate subsequent recipient(s) of a reportable food (section 417(d)(7)(C)(i) to (ii) of the FD&C Act). Notification to the immediate previous source(s) and immediate subsequent recipient(s) of the article of food may be accomplished by electronic communication methods such as email, fax, or text messaging or by telegrams, mailgrams, or first-class letters. Notification may also be accomplished by telephone call or other personal contacts but we recommend that such notifications also be confirmed by one of the previous methods and/or documented in an appropriate manner. We may require that the notification include any or all of the following data elements: (1) The date on which the article of food was determined to be a reportable food; (2) a description of the article of food including the quantity or amount; (3) the extent and nature of the adulteration; (4) the results of any investigation of the cause of the adulteration if it may have originated with the responsible party, if known; (5) the disposition of the article of food, when known; (6) product information typically found on packaging including product codes, use-by dates, and the names of manufacturers, packers, or distributors sufficient to identify the article of food; (7) contact information for the responsible party; (8) contact information for parties directly linked in the supply chain and notified under section 417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act, as applicable; (9) the information required by FDA to be included in the notification provided by the responsible party involved under section 417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act or required to report under section 417(d)(7)(A) of the FD&C Act; and (10) the unique number described in section 417(d)(4) of the FD&C Act (section 417(d)(6)(B)(iii)(I), (d)(7)(C)(iii)(I), and (e) of the FD&C Act). We may also require that the notification provides information about the actions that the recipient of the notification will perform and/or any other information we may require (section 417(d)(6)(B)(iii)(II) and (III), (d)(7)(C)(iii)(II) and (III) of the FD&C Act). Section 417(g) of the FD&C Act requires that responsible persons [[Page 44423]] maintain records related to reportable foods for a period of 2 years. The congressionally identified purpose of the Registry 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'' (FDAAA, section 1005(a)(4)). The reporting and recordkeeping requirements described previously are designed to enable FDA to quickly identify and track 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. We use the information collected under these provisions to help ensure that such products are quickly and efficiently removed from the market. As required under section 1005(f) of FDAAA and to assist industry, we have issued the guidance document entitled, ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007,'' which is available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm. The guidance contains questions and answers relating to the requirements under section 417 of the FD&C Act, including: (1) How, when, and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food. The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in questions 20 and 21 of the guidance have been approved under OMB control number 0910-0249. Description of Respondents: Mandatory respondents to this collection of information are the owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States (``responsible parties'') who have information on a reportable food. Voluntary respondents to this collection of information are Federal, State, and local public health officials who have information on a reportable food. In the Federal Register of June 7, 2017 (82 FR 26489), 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 1--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity/section Number of disclosures Total annual Average burden per disclosure Total hours respondents per respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- Notifying immediate previous source of the 1,200 1 1,200 0.6 (36 minutes)........................... 720 article of food under section 417(d)(6)(B)(i) of the FD&C Act (mandatory reporters only). Notifying immediate subsequent recipient of 1,200 1 1,200 0.6 (36 minutes)........................... 720 the article of food under section 417(d)(6)(B)(ii) of the FD&C Act (mandatory reporters only). Notifying immediate previous source of the 1 1,200 0.6 (36 720........................................ article of food under section minutes) 417(d)(7)(C)(i) of the FD&C Act (mandatory reporters only). Notifying immediate subsequent recipient of 1,200 1 1,200 0.6 (36 minutes)........................... 720 the article of food under section 417(d)(7)(C)(ii) of the FD&C Act (mandatory reporters only). ------------------------------------------------ --------------- Total.................................. .............. .............. .............. ........................................... 2,880 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Third Party Disclosure: We estimate that approximately 1,200 reportable food events with mandatory reporters will occur annually. Based on past FDA experiences, we estimate that we could receive 200 to 1,200 ``reportable'' food reports annually from 200 to 1,200 mandatory and voluntary users of the electronic reporting system. We utilized the upper-bound estimate of 1,200 for these calculations. We estimate that notifying the immediate previous source(s) will take 0.6 hours per reportable food and notifying the immediate subsequent recipient(s) will take 0.6 hours per reportable food. We also estimate that it will take 0.6 hours for the immediate previous source and/or the immediate subsequent recipient to also notify their immediate previous source(s) and/or immediate subsequent recipient(s). The Agency bases its estimate on its experience with mandatory and voluntary reports submitted to FDA. Although it is not mandatory under FDAAA, section 1005, that responsible persons notify the sources and recipients of instances of reportable food, for purposes of the burden estimate we are assuming FDA would exercise its authority and require such notifications in all such instances for mandatory reporters. This notification burden will not affect voluntary reporters of reportable food events. Therefore, we estimate that the total burden of notifying the immediate previous source(s) and immediate subsequent recipient(s) under section 417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and (ii) of the FD&C Act for 1,200 reportable foods will be 2,880 hours annually (1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours). This annual burden is shown in table 1. [[Page 44424]] Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity/section Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Maintenance of reportable food records 1,200 1 1,200 0.25 (15 minutes).......................... 300 under section 417(g) of the FD&C Act-- mandatory reports. Maintenance of reportable food records 4 1 4 0.25 (15 minutes).......................... 1 under section 417(g) of the FD&C Act-- voluntary reports. ------------------------------------------------ --------------- Total.................................. .............. .............. .............. ........................................... 301 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Recordkeeping: As noted previously, section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods reports and notifications under section 417 of the FD&C Act for a period of 2 years. Based on past FDA experiences, we estimate that each mandatory report and its associated notifications will require 30 minutes of recordkeeping for the 2-year period, or 15 minutes per record per year. The annual recordkeeping burden for mandatory reportable food reports and their associated notifications is thus estimated to be 300 hours (1,200 x 0.25 hours). We do not expect that records will always be kept in relation to voluntary reportable food reports. Therefore, we estimate that records will be kept for four voluntary reports we expect to receive annually. The recordkeeping burden associated with voluntary reports is thus estimated to be 1 hour annually (4 x 0.25 hours). The estimated total annual recordkeeping burden will be 301 hours annually (1,200 x 0.25 hours) + (4 x 0.25 hours). This annual burden is shown in table 2. Dated: September 19, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-20283 Filed 9-21-17; 8:45 am] BILLING CODE 4164-01-P
![44422 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
We base our estimate on our review DATES: Fax written comments on the responsible party to notify the
of the certification requests received collection of information by October 23, immediate previous source(s) and/or
over the past 3 fiscal years (FY). The 2017. immediate subsequent recipient(s) of a
annual burden estimate for this ADDRESSES: To ensure that comments on reportable food (section 417(d)(6)(B)(i)
information collection is 3,536 hours. the information collection are received, to (ii) of the FD&C Act). Similarly, we
The estimated reporting burden for this OMB recommends that written may also require the responsible party
information collection is 1,655 hours comments be faxed to the Office of that is notified (i.e., the immediate
and the estimated recordkeeping burden Information and Regulatory Affairs, previous source and/or immediate
for this information collection is 1,881 OMB, Attn: FDA Desk Officer, Fax: 202– subsequent recipient) to notify their
hours. From FY 2014 to FY 2016, we 395–7285, or emailed to oira_ own immediate previous source(s) and/
processed an average of 7,524 responses submission@omb.eop.gov. All or immediate subsequent recipient(s) of
(requests for certification of batches of comments should be identified with the a reportable food (section 417(d)(7)(C)(i)
color additives) per year. There were 38 OMB control number 0910–0643. Also to (ii) of the FD&C Act).
different respondents, corresponding to include the FDA docket number found Notification to the immediate
an average of approximately 198 in brackets in the heading of this previous source(s) and immediate
responses from each respondent per document. subsequent recipient(s) of the article of
year. Using information from industry food may be accomplished by electronic
FOR FURTHER INFORMATION CONTACT: Ila communication methods such as email,
personnel, we estimate that an average
S. Mizrachi, Office of Operations, Food fax, or text messaging or by telegrams,
of 0.22 hour per response is required for
and Drug Administration, Three White mailgrams, or first-class letters.
reporting (preparing certification
Flint North, 10A–12M, 11601 Notification may also be accomplished
requests and accompanying samples)
Landsdown St., North Bethesda, MD by telephone call or other personal
and an average of 0.25 hour per
20852, 301–796–7726, PRAStaff@ contacts but we recommend that such
response is required for recordkeeping.
fda.hhs.gov. notifications also be confirmed by one
FDA’s web-based Color Certification
information system allows submitters to SUPPLEMENTARY INFORMATION: In of the previous methods and/or
request color certification online, follow compliance with 44 U.S.C. 3507, FDA documented in an appropriate manner.
their submissions through the process, has submitted the following proposed We may require that the notification
and obtain information on account collection of information to OMB for include any or all of the following data
status. The system sends back the review and clearance. elements: (1) The date on which the
certification results electronically, article of food was determined to be a
Third Party Disclosure and reportable food; (2) a description of the
allowing submitters to sell their Recordkeeping Requirements for
certified color before receiving hardcopy article of food including the quantity or
Reportable Food—21 U.S.C. 350f amount; (3) the extent and nature of the
certificates. Any delays in the system
result only from shipment of color OMB Control Number 0910–0643— adulteration; (4) the results of any
additive samples to FDA’s Office of Extension investigation of the cause of the
Cosmetics and Colors for analysis. adulteration if it may have originated
The Federal Food, Drug, and Cosmetic with the responsible party, if known; (5)
Dated: September 15, 2017. Act (the FD&C Act), as amended by the the disposition of the article of food,
Anna K. Abram, Food and Drug Administration when known; (6) product information
Deputy Commissioner for Policy, Planning, Amendments Act of 2007 (FDAAA) typically found on packaging including
Legislation, and Analysis. (Pub. L. 110–85), requires the product codes, use-by dates, and the
[FR Doc. 2017–20245 Filed 9–21–17; 8:45 am] establishment of a Reportable Food names of manufacturers, packers, or
BILLING CODE 4164–01–P
Registry (the Registry) by which distributors sufficient to identify the
instances of reportable food must be article of food; (7) contact information
submitted to FDA by responsible parties for the responsible party; (8) contact
DEPARTMENT OF HEALTH AND and may be submitted by public health information for parties directly linked in
HUMAN SERVICES officials. Section 417 of the FD&C Act the supply chain and notified under
(21 U.S.C. 350f) defines ‘‘reportable section 417(d)(6)(B) or 417(d)(7)(C) of
Food and Drug Administration food’’ as an ‘‘article of food (other than the FD&C Act, as applicable; (9) the
infant formula) for which there is a information required by FDA to be
[Docket No. FDA–2009–N–0501] reasonable probability that the use of, or included in the notification provided by
Agency Information Collection exposure to, such article of food will the responsible party involved under
Activities; Submission for Office of cause serious adverse health section 417(d)(6)(B) or 417(d)(7)(C) of
Management and Budget Review; consequences or death to humans or the FD&C Act or required to report
Comment Request; Third Party animals.’’ (Section 417(a)(2) of the FD&C under section 417(d)(7)(A) of the FD&C
Disclosure and Recordkeeping Act.) We believe that the most efficient Act; and (10) the unique number
Requirements for Reportable Food and cost effective means to implement described in section 417(d)(4) of the
the Registry is by utilizing our FD&C Act (section 417(d)(6)(B)(iii)(I),
AGENCY: Food and Drug Administration, electronic Safety Reporting Portal. The (d)(7)(C)(iii)(I), and (e) of the FD&C Act).
HHS. information collection provisions We may also require that the
ACTION: Notice. associated with the submission of notification provides information about
reportable food reports has been the actions that the recipient of the
SUMMARY: The Food and Drug approved under OMB control number notification will perform and/or any
Administration (FDA) is announcing 0910–0643. other information we may require
that a proposed collection of In conjunction with the reportable (section 417(d)(6)(B)(iii)(II) and (III),
information has been submitted to the foods requirements, section 417 of the (d)(7)(C)(iii)(II) and (III) of the FD&C
Office of Management and Budget FD&C Act also establishes third party Act).
(OMB) for review and clearance under disclosure and recordkeeping burdens. Section 417(g) of the FD&C Act
the Paperwork Reduction Act of 1995. Specifically, we may require the requires that responsible persons
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![Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44423
maintain records related to reportable As required under section 1005(f) of information in questions 20 and 21 of
foods for a period of 2 years. FDAAA and to assist industry, we have the guidance have been approved under
The congressionally identified issued the guidance document entitled, OMB control number 0910–0249.
purpose of the Registry is to provide ‘‘a ‘‘Questions and Answers Regarding the Description of Respondents:
reliable mechanism to track patterns of Reportable Food Registry as Established Mandatory respondents to this
adulteration in food [which] would by the Food and Drug Administration collection of information are the
support efforts by the Food and Drug Amendments Act of 2007,’’ which is owners, operators, or agents in charge of
Administration to target limited available at https://www.fda.gov/Food/ a domestic or foreign facility engaged in
inspection resources to protect the GuidanceRegulation/Guidance manufacturing, processing, packing, or
public health’’ (FDAAA, section DocumentsRegulatoryInformation/ holding food for consumption in the
1005(a)(4)). The reporting and ucm180761.htm. The guidance contains United States (‘‘responsible parties’’)
recordkeeping requirements described questions and answers relating to the who have information on a reportable
previously are designed to enable FDA requirements under section 417 of the food. Voluntary respondents to this
to quickly identify and track an article FD&C Act, including: (1) How, when, collection of information are Federal,
of food (other than infant formula) for and where to submit reports to FDA; (2) State, and local public health officials
which there is a reasonable probability who is required to submit reports to who have information on a reportable
that the use of or exposure to such FDA; (3) what is required to be food.
article of food will cause serious adverse submitted to FDA; and (4) what may be In the Federal Register of June 7, 2017
health consequences or death to humans required when providing notifications (82 FR 26489), FDA published a 60-day
or animals. We use the information to other persons in the supply chain of notice requesting public comment on
collected under these provisions to help an article of food. The guidance also the proposed collection of information.
ensure that such products are quickly refers to previously approved No comments were received.
and efficiently removed from the collections of information found in FDA We estimate the burden of this
market. regulations. The collections of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden
Activity/section Total hours
respondents per disclosures per disclosure
respondent
Notifying immediate previous source of the article 1,200 1 1,200 0.6 (36 minutes) .......... 720
of food under section 417(d)(6)(B)(i) of the
FD&C Act (mandatory reporters only).
Notifying immediate subsequent recipient of the 1,200 1 1,200 0.6 (36 minutes) .......... 720
article of food under section 417(d)(6)(B)(ii) of
the FD&C Act (mandatory reporters only).
Notifying immediate previous source of the article 1 1,200 0.6 (36 720.
of food under section 417(d)(7)(C)(i) of the minutes)
FD&C Act (mandatory reporters only).
Notifying immediate subsequent recipient of the 1,200 1 1,200 0.6 (36 minutes) .......... 720
article of food under section 417(d)(7)(C)(ii) of
the FD&C Act (mandatory reporters only).
Total ................................................................ ........................ ........................ ........................ ..................................... 2,880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Third Party Disclosure: We estimate reportable food. We also estimate that it notifications in all such instances for
that approximately 1,200 reportable will take 0.6 hours for the immediate mandatory reporters. This notification
food events with mandatory reporters previous source and/or the immediate burden will not affect voluntary
will occur annually. Based on past FDA subsequent recipient to also notify their reporters of reportable food events.
experiences, we estimate that we could immediate previous source(s) and/or Therefore, we estimate that the total
receive 200 to 1,200 ‘‘reportable’’ food immediate subsequent recipient(s). The burden of notifying the immediate
reports annually from 200 to 1,200 Agency bases its estimate on its previous source(s) and immediate
mandatory and voluntary users of the experience with mandatory and subsequent recipient(s) under section
electronic reporting system. We utilized voluntary reports submitted to FDA. 417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and
the upper-bound estimate of 1,200 for Although it is not mandatory under
(ii) of the FD&C Act for 1,200 reportable
these calculations. FDAAA, section 1005, that responsible
foods will be 2,880 hours annually
We estimate that notifying the persons notify the sources and
immediate previous source(s) will take recipients of instances of reportable (1,200 × 0.6 hours) + (1,200 × 0.6 hours)
0.6 hours per reportable food and food, for purposes of the burden + (1,200 × 0.6 hours) + (1,200 × 0.6
notifying the immediate subsequent estimate we are assuming FDA would hours). This annual burden is shown in
recipient(s) will take 0.6 hours per exercise its authority and require such table 1.
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden
Activity/section records per Total hours
recordkeepers records per recordkeeping
recordkeeper
Maintenance of reportable food records under 1,200 1 1,200 0.25 (15 minutes) ........ 300
section 417(g) of the FD&C Act—mandatory re-
ports.
Maintenance of reportable food records under 4 1 4 0.25 (15 minutes) ........ 1
section 417(g) of the FD&C Act—voluntary re-
ports.
Total ................................................................ ........................ ........................ ........................ ..................................... 301
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping: As noted previously, ACTION: Notice. significant services directly to the
section 417(g) of the FD&C Act requires public’’ to ‘‘survey customers to
that responsible persons maintain SUMMARY: The Food and Drug determine the kind and quality of
records related to reportable foods Administration (FDA or we) is
services they want and their level of
reports and notifications under section announcing that a proposed collection
of information has been submitted to the satisfaction with existing services.’’ FDA
417 of the FD&C Act for a period of 2 is seeking OMB clearance to conduct a
years. Based on past FDA experiences, Office of Management and Budget
(OMB) for review and clearance under series of surveys to implement
we estimate that each mandatory report Executive Order 12862. Participation in
and its associated notifications will the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the the surveys is voluntary. This request
require 30 minutes of recordkeeping for
collection of information by October 23, covers customer/partner service surveys
the 2-year period, or 15 minutes per
2017. of regulated entities, such as food
record per year. The annual
recordkeeping burden for mandatory ADDRESSES: To ensure that comments on processors; cosmetic drug, biologic and
reportable food reports and their the information collection are received, medical device manufacturers;
associated notifications is thus OMB recommends that written consumers; and health professionals.
estimated to be 300 hours (1,200 × 0.25 comments be faxed to the Office of The request also covers ‘‘partner’’ (State
hours). Information and Regulatory Affairs, and local governments) customer
We do not expect that records will OMB, Attn: FDA Desk Officer, Fax: 202– service surveys.
always be kept in relation to voluntary 395–7285, or emailed to oira_ FDA will use the information from
reportable food reports. Therefore, we submission@omb.eop.gov. All these surveys to identify strengths and
estimate that records will be kept for comments should be identified with the weaknesses in service to customers/
four voluntary reports we expect to OMB control number 0910–0360. Also partners and to make improvements.
receive annually. The recordkeeping include the FDA docket number found The surveys will measure timeliness,
burden associated with voluntary in brackets in the heading of this
appropriateness and accuracy of
reports is thus estimated to be 1 hour document.
information, and courtesy and problem
annually (4 × 0.25 hours). The estimated FOR FURTHER INFORMATION CONTACT:
total annual recordkeeping burden will resolution in the context of individual
Amber Sanford, Office of Operations, programs.
be 301 hours annually (1,200 × 0.25 Food and Drug Administration, Three
hours) + (4 × 0.25 hours). This annual White Flint North, 10A–12M, 11601 FDA estimates conducting 15
burden is shown in table 2. Landsdown St., North Bethesda, MD customer/partner service surveys per
Dated: September 19, 2017. 20852, 301–796–8867, PRAStaff@ year, each requiring an average of 15
Leslie Kux, fda.hhs.gov. minutes for review and completion. We
Associate Commissioner for Policy. estimate respondents to these surveys to
SUPPLEMENTARY INFORMATION: In
be between 100 and 20,000 customers.
[FR Doc. 2017–20283 Filed 9–21–17; 8:45 am] compliance with 44 U.S.C. 3507, FDA
BILLING CODE 4164–01–P has submitted the following proposed Some of these surveys will be repeats of
collection of information to OMB for earlier surveys for purposes of
review and clearance. monitoring customer/partner service
DEPARTMENT OF HEALTH AND and developing long-term data.
HUMAN SERVICES Customer/Partner Service Surveys
In the Federal Register of June 7, 2017
OMB Control Number 0910–0360— (82 FR 26497), FDA published a 60-day
Food and Drug Administration Extension notice requesting public comment on
[Docket No. FDA–2011–N–0019] Under section 903 of the Federal the proposed collection of information.
Food, Drug, and Cosmetic Act (21 U.S.C. No comments were received.
Agency Information Collection
393), FDA is authorized to conduct FDA estimates the burden of this
Activities; Submission for Office of
research and public information collection of information as follows:
Management and Budget Review;
programs about regulated products and
Comment Request; Customer/Partner
responsibilities of the Agency.
Service Surveys
Executive Order 12862, entitled,
AGENCY: Food and Drug Administration, ‘‘Setting Customer Service Standard,’’
HHS. directs Federal Agencies that ‘‘provide
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Document Created: 2017-09-22 01:52:27
Document Modified: 2017-09-22 01:52:27
| 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 October 23, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 44422 |
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