82 FR 44424 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys
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 | 44424-44425 | |
| FR Document | 2017-20246 |
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)] [Notices] [Pages 44424-44425] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20246] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0019] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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 0910-0360. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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. Customer/Partner Service Surveys OMB Control Number 0910-0360--Extension Under section 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393), FDA is authorized to conduct research and public information programs about regulated products and responsibilities of the Agency. Executive Order 12862, entitled, ``Setting Customer Service Standard,'' directs Federal Agencies that ``provide significant services directly to the public'' to ``survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services.'' FDA is seeking OMB clearance to conduct a series of surveys to implement Executive Order 12862. Participation in the surveys is voluntary. This request covers customer/partner service surveys of regulated entities, such as food processors; cosmetic drug, biologic and medical device manufacturers; consumers; and health professionals. The request also covers ``partner'' (State and local governments) customer service surveys. FDA will use the information from these surveys to identify strengths and weaknesses in service to customers/partners and to make improvements. The surveys will measure timeliness, appropriateness and accuracy of information, and courtesy and problem resolution in the context of individual programs. FDA estimates conducting 15 customer/partner service surveys per year, each requiring an average of 15 minutes for review and completion. We estimate respondents to these surveys to be between 100 and 20,000 customers. Some of these surveys will be repeats of earlier surveys for purposes of monitoring customer/partner service and developing long-term data. In the Federal Register of June 7, 2017 (82 FR 26497), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: [[Page 44425]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Annual Type of survey Number of frequency per Hours per response Total hours respondents response ---------------------------------------------------------------------------------------------------------------- Mail, telephone, web-based........ 55,000 1 .25 (15 minutes)............ 13,750 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 15, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20246 Filed 9-21-17; 8:45 am] BILLING CODE 4164-01-P
![44424 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
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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![Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44425
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
Number of Hours per
Type of survey frequency per Total hours
respondents response
response
Mail, telephone, web-based ..................................................................... 55,000 1 .25 (15 minutes) .... 13,750
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 15, 2017. Comments submitted electronically, submission. You should submit two
Anna K. Abram, including attachments, to https:// copies total. One copy will include the
Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to information you claim to be confidential
Legislation, and Analysis. the docket unchanged. Because your with a heading or cover note that states
[FR Doc. 2017–20246 Filed 9–21–17; 8:45 am] comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
BILLING CODE 4164–01–P solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
comment does not include any Agency will review this copy, including
confidential information that you or a the claimed confidential information, in
DEPARTMENT OF HEALTH AND third party may not wish to be posted, its consideration of comments. The
HUMAN SERVICES such as medical information, your or second copy, which will have the
anyone else’s Social Security number, or claimed confidential information
Food and Drug Administration confidential business information, such redacted/blacked out, will be available
[Docket No. FDA–2017–D–5525] as a manufacturing process. Please note for public viewing and posted on
that if you include your name, contact https://www.regulations.gov. Submit
Statistical Approaches To Evaluate information, or other information that both copies to the Dockets Management
Analytical Similarity; Draft Guidance identifies you in the body of your Staff. If you do not wish your name and
for Industry; Availability comments, that information will be contact information to be made publicly
posted on https://www.regulations.gov. available, you can provide this
AGENCY: Food and Drug Administration, • If you want to submit a comment information on the cover sheet and not
HHS. with confidential information that you in the body of your comments and you
ACTION: Notice of availability. do not wish to be made available to the must identify this information as
public, submit the comment as a ‘‘confidential.’’ Any information marked
SUMMARY: The Food and Drug as ‘‘confidential’’ will not be disclosed
written/paper submission and in the
Administration (FDA or Agency) is except in accordance with 21 CFR 10.20
manner detailed (see ‘‘Written/Paper
announcing the availability of a draft and other applicable disclosure law. For
Submissions’’ and ‘‘Instructions’’).
guidance for industry entitled more information about FDA’s posting
‘‘Statistical Approaches to Evaluate Written/Paper Submissions of comments to public dockets, see 80
Analytical Similarity.’’ This draft Submit written/paper submissions as FR 56469, September 18, 2015, or access
guidance, when finalized, will provide follows: the information at: https://www.gpo.gov/
advice on the evaluation of analytical • Mail/Hand delivery/Courier (for fdsys/pkg/FR-2015-09-18/pdf/2015-
similarity to sponsors interested in written/paper submissions): Dockets 23389.pdf.
developing biosimilar products. Management Staff (HFA–305), Food and Docket: For access to the docket to
Specifically, this draft guidance Drug Administration, 5630 Fishers read background documents or the
describes the type of information a Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments
sponsor of a proposed biosimilar • For written/paper comments received, go to https://www.regulations.
product should obtain about the submitted to the Dockets Management gov and insert the docket number, found
structural/physicochemical and Staff, FDA will post your comment, as in brackets in the heading of this
functional attributes of the reference well as any attachments, except for document, into the ‘‘Search’’ box and
product, how that information is used in information submitted, marked and follow the prompts and/or go to the
the development of an analytical identified, as confidential, if submitted Dockets Management Staff, 5630 Fishers
similarity assessment plan for the as detailed in ‘‘Instructions.’’ Lane, Rm. 1061, Rockville, MD 20852.
proposed biosimilar, and the statistical Instructions: All submissions received You may submit comments on any
approaches recommended for evaluating must include the Docket No. FDA– guidance at any time (see 21 CFR
analytical similarity. 2017–D–5525 for ‘‘Statistical 10.115(g)(5)). Submit written requests
DATES: Submit either electronic or Approaches to Evaluate Analytical for single copies of the draft guidance to
written comments on the draft guidance Similarity; Draft Guidance for Industry; the Division of Drug Information, Center
by November 21, 2017 to ensure that the Availability.’’ Received comments will for Drug Evaluation and Research, Food
Agency considers your comment on this be placed in the docket and, except for and Drug Administration, 10001 New
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Document Created: 2017-09-22 01:52:22
Document Modified: 2017-09-22 01:52:22
| 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 | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 44424 |
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