81 FR 8723 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 34 (February 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 34 (February 22, 2016)
| Page Range | 8723-8724 | |
| FR Document | 2016-03549 |
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)] [Notices] [Pages 8723-8724] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03549] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3655] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water 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 March 23, 2016. 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 0910-0658. Also include the FDA 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, [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. Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water--21 CFR 129.35(a)(3)(i), 129.80(g), and 129.80(h)--OMB Control Number 0910-0658--Extension The bottled water regulations in parts 129 and 165 (21 CFR parts 129 and 165) require that if any coliform organisms are detected in weekly total coliform testing of finished bottled water, followup testing must be conducted to determine whether any of the coliform organisms are Escherichia coli. The adulteration provision of the bottled water standard (Sec. 165.110(d)) provides that a finished product that tests positive for E. coli will be deemed adulterated under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)). In addition, the current good manufacturing practice (CGMP) regulations for bottled water in part 129 require that source water from other than a public water system (PWS) be tested at least weekly for total coliform. If any coliform organisms are detected in the source water, the bottled water manufacturers are required to determine whether any of the coliform organisms are E. coli. Source water found to contain E. coli is not considered water of a safe, sanitary quality and would be unsuitable for bottled water production. Before a bottler may use source water from a source that has tested positive for E. coli, a bottler must take appropriate measures to rectify or otherwise eliminate the cause of the contamination. A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be E. coli negative. Description of Respondents: The respondents to this information collection are domestic and foreign bottled water manufacturers that sell bottled water in the United States. In the Federal Register of October 19, 2015 (80 FR 63228) 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 Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Total 21 CFR Section; Activity Number of records per annual Average burden per Total recordkeepers recordkeeper records recordkeeping hours ---------------------------------------------------------------------------------------------------------------- Sec. 129.35(a)(3)(i), Sec. 319 6 1,914 0.08 (5 minutes) 153 129.80(h); Bottlers subject to source water and finished product testing. Sec. 129.80(g), Sec. 95 3 285 0.08 (5 minutes) 23 129.80(h); Bottlers testing finished product only. Sec. 129.35(a)(3)(i), Sec. 3 5 15 0.08 (5 minutes) 1 129.80(h); Bottlers conducting secondary testing of source water. Sec. 129.35(a)(3)(i), Sec. 3 3 9 0.25 (15 minutes) 2 129.80(h); Bottlers rectifying contamination. ------------------------------------------------------------------------------- Total Annual Burden......... .............. .............. ........... ....................... 179 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The current CGMP regulations already reflect the time and associated recordkeeping costs for those bottlers that are required to conduct microbiological testing of their source water, as well as total coliform testing of their finished bottled water products. We therefore conclude that any additional burden and costs in recordkeeping based on followup testing that is required if any coliform organisms detected in the source water test positive for E.coli are negligible. We estimate that the labor burden of keeping records of each test is about 5 minutes per test. We also require followup testing of source water and finished bottled water products for E. coli when total coliform positives occur. We expect that 319 bottlers that use sources other than PWSs may find a total coliform positive sample about three times per year in source testing and about three times in finished product testing, for a total of 153 hours of recordkeeping. In addition to the 319 bottlers, about 95 bottlers that use PWSs [[Page 8724]] may find a total coliform positive sample about three times per year in finished product testing, for a total of 23 hours of recordkeeping. Upon finding a total coliform sample, bottlers will then have to conduct a followup test for E. coli. We expect that recordkeeping for the followup test for E. coli will also take about 5 minutes per test. As shown in table 1 of this document, we expect that three bottlers per year will have to carry out the additional E. coli testing, with a burden of 1 hour. These bottlers will also have to keep records about rectifying the source contamination, for a burden of 2 hours. For all expected total coliform testing, E. coli testing, and source rectification, we estimate a total burden of 179 hours. We base our estimate on our experience with the current CGMP regulations. Dated: February 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03549 Filed 2-19-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices 8723
www.regulations.gov may be viewed in OMB recommends that written adulterated under section 402(a)(3) of
the Division of Dockets Management comments be faxed to the Office of the Federal Food, Drug, and Cosmetic
between 9 a.m. and 4 p.m., Monday Information and Regulatory Affairs, Act (21 U.S.C. 342(a)(3)). In addition,
through Friday. OMB, Attn: FDA Desk Officer, FAX: the current good manufacturing practice
Dated: February 16, 2016. 202–395–7285, or emailed to oira_ (CGMP) regulations for bottled water in
submission@omb.eop.gov. All part 129 require that source water from
Leslie Kux,
comments should be identified with the other than a public water system (PWS)
Associate Commissioner for Policy.
OMB control number 0910–0658. Also be tested at least weekly for total
[FR Doc. 2016–03542 Filed 2–19–16; 8:45 am] include the FDA docket number found coliform. If any coliform organisms are
BILLING CODE 4164–01–P in brackets in the heading of this detected in the source water, the bottled
document. water manufacturers are required to
FOR FURTHER INFORMATION CONTACT: FDA determine whether any of the coliform
DEPARTMENT OF HEALTH AND
PRA Staff, Office of Operations, Food organisms are E. coli. Source water
HUMAN SERVICES
and Drug Administration, 8455 found to contain E. coli is not
Food and Drug Administration Colesville Rd., COLE–14526, Silver considered water of a safe, sanitary
Spring, MD 20993–0002, PRAStaff@ quality and would be unsuitable for
[Docket No. FDA–2015–N–3655] bottled water production. Before a
fda.hhs.gov.
bottler may use source water from a
Agency Information Collection SUPPLEMENTARY INFORMATION: In
source that has tested positive for E.
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA
coli, a bottler must take appropriate
Management and Budget Review; has submitted the following proposed
measures to rectify or otherwise
Comment Request; Recordkeeping collection of information to OMB for
eliminate the cause of the
Requirements for Microbiological review and clearance.
contamination. A source previously
Testing and Corrective Measures for Recordkeeping Requirements for found to contain E. coli will be
Bottled Water Microbiological Testing and Corrective considered negative for E. coli after five
AGENCY: Food and Drug Administration, Measures for Bottled Water—21 CFR samples collected over a 24-hour period
HHS. 129.35(a)(3)(i), 129.80(g), and from the same sampling site are tested
ACTION: Notice. 129.80(h)—OMB Control Number 0910– and found to be E. coli negative.
0658—Extension Description of Respondents: The
SUMMARY: The Food and Drug The bottled water regulations in parts respondents to this information
Administration (FDA) is announcing 129 and 165 (21 CFR parts 129 and 165) collection are domestic and foreign
that a proposed collection of require that if any coliform organisms bottled water manufacturers that sell
information has been submitted to the are detected in weekly total coliform bottled water in the United States.
Office of Management and Budget testing of finished bottled water, In the Federal Register of October 19,
(OMB) for review and clearance under followup testing must be conducted to 2015 (80 FR 63228) FDA published a 60-
the Paperwork Reduction Act of 1995. determine whether any of the coliform day notice requesting public comment
DATES: Fax written comments on the organisms are Escherichia coli. The on the proposed collection of
collection of information by March 23, adulteration provision of the bottled information. No comments were
2016. water standard (§ 165.110(d)) provides received.
ADDRESSES: To ensure that comments on that a finished product that tests We estimate the burden of this
the information collection are received, positive for E. coli will be deemed collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual Total
21 CFR Section; Activity records per burden per
recordkeepers records hours
recordkeeper recordkeeping
§ 129.35(a)(3)(i), § 129.80(h); Bottlers subject to source water 319 6 1,914 0.08 (5 minutes) 153
and finished product testing.
§ 129.80(g), § 129.80(h); Bottlers testing finished product only .... 95 3 285 0.08 (5 minutes) 23
§ 129.35(a)(3)(i), § 129.80(h); Bottlers conducting secondary test- 3 5 15 0.08 (5 minutes) 1
ing of source water.
§ 129.35(a)(3)(i), § 129.80(h); Bottlers rectifying contamination .... 3 3 9 0.25 (15 min- 2
utes)
Total Annual Burden ............................................................... 179
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The current CGMP regulations already recordkeeping based on followup testing coli when total coliform positives occur.
reflect the time and associated that is required if any coliform We expect that 319 bottlers that use
mstockstill on DSK4VPTVN1PROD with NOTICES
recordkeeping costs for those bottlers organisms detected in the source water sources other than PWSs may find a
that are required to conduct test positive for E.coli are negligible. We total coliform positive sample about
microbiological testing of their source estimate that the labor burden of three times per year in source testing
water, as well as total coliform testing keeping records of each test is about 5 and about three times in finished
of their finished bottled water products. minutes per test. We also require product testing, for a total of 153 hours
We therefore conclude that any followup testing of source water and of recordkeeping. In addition to the 319
additional burden and costs in finished bottled water products for E. bottlers, about 95 bottlers that use PWSs
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![8724 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
may find a total coliform positive FDA Advisory Committee Information accommodated during the scheduled
sample about three times per year in Line, 1–800–741–8138 (301–443–0572 open public hearing session, FDA may
finished product testing, for a total of 23 in the Washington, DC area). A notice in conduct a lottery to determine the
hours of recordkeeping. Upon finding a the Federal Register about last minute speakers for the scheduled open public
total coliform sample, bottlers will then modifications that impact a previously hearing session. The contact person will
have to conduct a followup test for E. announced advisory committee meeting notify interested persons regarding their
coli. cannot always be published quickly request to speak by March 25, 2016.
We expect that recordkeeping for the enough to provide timely notice. Persons attending FDA’s advisory
followup test for E. coli will also take Therefore, you should always check the committee meetings are advised that the
about 5 minutes per test. As shown in Agency’s Web site at http://www.fda. Agency is not responsible for providing
table 1 of this document, we expect that gov/AdvisoryCommittees/default.htm access to electrical outlets.
three bottlers per year will have to carry and scroll down to the appropriate FDA welcomes the attendance of the
out the additional E. coli testing, with a advisory committee meeting link, or call public at its advisory committee
burden of 1 hour. These bottlers will the advisory committee information line meetings and will make every effort to
also have to keep records about to learn about possible modifications accommodate persons with disabilities.
rectifying the source contamination, for before coming to the meeting. If you require accommodations due to a
a burden of 2 hours. For all expected Agenda: The committee will discuss disability, please contact Moon Hee V.
total coliform testing, E. coli testing, and data submitted by Galderma Choi at least 7 days in advance of the
source rectification, we estimate a total Laboratories, L.P. to support meeting.
burden of 179 hours. We base our supplemental new drug application FDA is committed to the orderly
estimate on our experience with the (sNDA) 20–380, for over-the-counter conduct of its advisory committee
current CGMP regulations. (OTC) marketing of adapalene gel 0.1%. meetings. Please visit our Web site at
The proposed OTC use is for the http://www.fda.gov/Advisory
Dated: February 16, 2016. treatment of acne and to clear up acne
Leslie Kux,
Committees/AboutAdvisoryCommittees/
pimples and acne blemishes. The ucm111462.htm for procedures on
Associate Commissioner for Policy. applicant proposes to label the product public conduct during advisory
[FR Doc. 2016–03549 Filed 2–19–16; 8:45 am] for 12 years and older. The committee committee meetings.
BILLING CODE 4164–01–P will be asked to consider whether data Notice of this meeting is given under
support an acceptable risk/benefit the Federal Advisory Committee Act (5
profile for the nonprescription use of U.S.C. app. 2).
DEPARTMENT OF HEALTH AND adapalene gel 0.1% by OTC consumers.
HUMAN SERVICES FDA intends to make background Dated: February 17, 2016.
material available to the public no later Jill Hartzler Warner,
Food and Drug Administration than 2 business days before the meeting. Associate Commissioner for Special Medical
If FDA is unable to post the background Programs.
[Docket No. FDA–2016–N–0001]
material on its Web site prior to the [FR Doc. 2016–03573 Filed 2–19–16; 8:45 am]
Nonprescription Drugs Advisory meeting, the background material will BILLING CODE 4164–01–P
Committee; Notice of Meeting be made publicly available at the
location of the advisory committee
AGENCY: Food and Drug Administration, meeting, and the background material DEPARTMENT OF HEALTH AND
HHS. will be posted on FDA’s Web site after HUMAN SERVICES
ACTION: Notice. the meeting. Background material is
available at http://www.fda.gov/ Food and Drug Administration
This notice announces a forthcoming AdvisoryCommittees/Calendar/ [Docket No. FDA–2014–E–2346]
meeting of a public advisory committee default.htm. Scroll down to the
of the Food and Drug Administration appropriate advisory committee meeting Determination of Regulatory Review
(FDA). The meeting will be open to the link. Period for Purposes of Patent
public. Procedure: Interested persons may Extension; BREO ELLIPTA
Name of Committee: Nonprescription present data, information, or views,
Drugs Advisory Committee. orally or in writing, on issues pending AGENCY: Food and Drug Administration,
General Function of the Committee: before the committee. Written HHS.
To provide advice and submissions may be made to the contact ACTION: Notice.
recommendations to the Agency on person on or before April 1, 2016. Oral
FDA’s regulatory issues. presentations from the public will be SUMMARY: The Food and Drug
Date and Time: The meeting will be scheduled between approximately 1 Administration (FDA) has determined
held on April 15, 2016, from 8 a.m. to p.m. and 2 p.m. Those individuals the regulatory review period for BREO
5 p.m. interested in making formal oral ELLIPTA and is publishing this notice
Location: Hilton Washington DC presentations should notify the contact of that determination as required by
North/Gaithersburg, Grand Ballroom, person and submit a brief statement of law. FDA has made the determination
620 Perry Pkwy., Gaithersburg, MD the general nature of the evidence or because of the submission of an
20877. The hotel’s telephone number is arguments they wish to present, the application to the Director of the U.S.
Patent and Trademark Office (USPTO),
mstockstill on DSK4VPTVN1PROD with NOTICES
301–977–8900. names and addresses of proposed
Contact Person: Moon Hee V. Choi, participants, and an indication of the Department of Commerce, for the
Center for Drug Evaluation and approximate time requested to make extension of a patent which claims that
Research, Food and Drug their presentation on or before March human drug product.
Administration, 10903 New Hampshire 24, 2016. Time allotted for each DATES: Anyone with knowledge that any
Ave., Bldg. 31, Rm. 2417, Silver Spring, presentation may be limited. If the of the dates as published (in the
MD 20993–0002, 301–796–9001, FAX: number of registrants requesting to SUPPLEMENTARY INFORMATION section) are
301–847–8533, NDAC@fda.hhs.gov, or speak is greater than can be reasonably incorrect may submit either electronic
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Document Created: 2016-02-19 23:56:47
Document Modified: 2016-02-19 23:56:47
| 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 March 23, 2016. | |
| 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 | 81 FR 8723 |
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