83 FR 58582 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Current Manufacturing Practices for the Cosmetics Industry
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 224 (November 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 224 (November 20, 2018)
| Page Range | 58582-58583 | |
| FR Document | 2018-25231 |
[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)] [Notices] [Pages 58582-58583] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25231] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2027] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Current Manufacturing Practices for the Cosmetics Industry 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 (PRA). DATES: Fax written comments on the collection of information by December 20, 2018. 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--New and title ``Survey of Current Manufacturing Practices for the Cosmetics Industry.'' 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. Survey of Current Manufacturing Practices for the Cosmetics Industry OMB Control Number 0910--NEW FDA has the responsibility to protect public health and, as part of this broad mandate, oversees the safety of the nation's cosmetic products. The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the introduction into interstate commerce of any cosmetic that is adulterated or misbranded; cosmetics are also to be safe and properly labeled. The FD&C Act defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, deodorants, and tattoo inks, as well as any substance intended for use as a component of a cosmetic product. Some cosmetic products are also regulated as drugs. As with other commodities FDA regulates, the safety of cosmetic products can be ensured in part through a manufacturer's approach to the management of cosmetic quality. To date, FDA has not identified in the published literature any systematic, detailed study of the diversity of the practices and standards employed across the cosmetic industry. This study is intended to fill this gap. FDA proposes to conduct a voluntary survey of cosmetics establishments to identify the current manufacturing practices in the cosmetic industry. The survey instrument will collect data, on a voluntary basis, from cosmetic product manufacturers on the following topics:Written Procedures and Documentation--including written procedures and records for manufacturing involving personnel, raw materials, processing, cleaning, maintenance, finished products, and training. Buildings and Equipment--including facility space, pest control, practices ensuring the cleanliness and sanitation, water usage and treatment, and the proper functioning and operation of equipment. Materials and Manufacturing--including practices for inventory management, labeling and storage of raw materials, closures, and in process materials, and in process standard operating procedures. Quality Control/Product Testing--including the scope of the quality control unit, laboratory testing, dealing with rejected or returned products and complaints, and corrective actions. In addition, FDA will obtain the characteristics of surveyed establishments such as the types of cosmetics produced, published standards and guidelines followed, the number of employees, the volume of production, and the approximate [[Page 58583]] revenue. The survey will be administered by web or by mail (respondent choice) and it will be directed to the Plant Manager of the cosmetics establishment. This is a new, one-time data collection. FDA does not plan to collect this data from the cosmetics industry on an ongoing basis. In the Federal Register of July 2, 2018 (83 FR 30940), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received three comments. FDA thanks the commenters for their comments and provides our responses below. The first comment expressed concern that the collection was voluntary, and a number of manufacturers may not participate, which will not inform FDA of manufacturers who are not observing good manufacturing practices. They also indicated that they feel the survey could help set future standards for the industry. In response to this comment, FDA notes that this survey is being conducted to inform FDA with updated information about the practices and standards employed across the cosmetics industry. With regard to identifying manufacturers who are not observing good manufacturing practices, the survey is structured to provide FDA with anonymized, updated cosmetic industry information, not individual response information about any of its participants. The second comment addressed specific PRA issues of necessity, burden estimate, quality and utility of the survey, and method of collection. The commenter feels that the survey is not necessary for proper FDA oversight of the industry because this information is already available to FDA through its facility inspections. They also indicated that they had not seen the actual questions on the survey, and therefore felt the burden estimate was not feasible. They suggested that FDA partner with outside sources to assist FDA in gathering information about the industry and thought that web or mail collection was reasonable. In response to the second comment, FDA noted in the Federal Register of July 2, 2018 that FDA has ``not identified in the published literature any systematic, detailed study of the diversity of the practices and standards employed across the cosmetic industry to ensure product quality and safety.'' FDA is conducting this survey to fill this gap in knowledge, and this survey is necessary to achieve this goal. With regard to the survey itself, it is (and has been) available at the FDA Docket assigned to this collection (FDA-2018-N-2027). We agree that the burden is likely greater than 30 minutes, and based on results of our pretest with six individuals, we have increased the burden estimate to 60 minutes. FDA's contractor did consult with industry stakeholders in the development of the survey instrument. Finally, FDA thanks the commenter for their comments and thoughts that our suggested method of web or collection method was reasonable. The third comment was not related to the PRA and will not be addressed at this time. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Survey Invitation............................ 898 1 898 0.08 (5 minutes)......................... 71.84 Survey....................................... 564 1 564 1........................................ 564 ---------------------------------------------------------------------------------------------------------- Total.................................... .............. .............. .............. ......................................... 635.84 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We will select a sample of 898 establishments. After adjusting for ineligibility (i.e., firms that do not produce cosmetic products and those no longer in operation) and a response rate of 70 percent, we expect 564 completed surveys. We expect each individual survey invitation to take 5 minutes (0.08 hour) to complete. Multiplying by the 898 establishments that will receive the survey invitation, we estimate the time burden of the survey invitation to be 71.84 hours. Previously, we estimated that the survey would take 30 minutes to complete. However, based on our pretest with six individuals, we now expect each individual survey to take, on average, 60 minutes (1 hour) to complete. Multiplying by the estimated 564 establishments that will complete the survey, we estimate the time burden of the survey to be 564 hours. We estimate the total hourly reporting burden for this collection of information to be 635.84 hours. Dated: November 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25231 Filed 11-19-18; 8:45 am] BILLING CODE 4164-01-P
![58582 Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices
4. In a situation where the output of DEPARTMENT OF HEALTH AND cosmetics are also to be safe and
prescription drug-use-related software HUMAN SERVICES properly labeled.
includes a benefit claim about the drug, what The FD&C Act defines cosmetics as
should FDA consider when providing Food and Drug Administration articles intended to be rubbed, poured,
recommendations on how to appropriately sprinkled, or sprayed on, introduced
[Docket No. FDA–2018–N–2027]
address the balancing of benefit information into, or otherwise applied to the human
and risk information? Agency Information Collection body for cleansing, beautifying,
5. Does the proposed framework Activities; Submission for Office of promoting attractiveness, or altering the
appropriately characterize the types of Management and Budget Review; appearance. Among the products
prescription drug-use-related software output included in this definition are skin
Comment Request; Survey of Current
that should be submitted for advisory moisturizers, perfumes, lipsticks,
Manufacturing Practices for the
comment? (See Section II.C., Prescription fingernail polishes, eye and facial
Cosmetics Industry
Drug-Use-Related Software Output That makeup, cleansing shampoos,
Constitutes Promotional Labeling) Are there AGENCY: Food and Drug Administration, permanent waves, hair colors,
other examples for which advisory comment HHS. deodorants, and tattoo inks, as well as
should be recommended because there is a ACTION: Notice. any substance intended for use as a
strong potential that the prescription drug- component of a cosmetic product. Some
use-related software output will increase the SUMMARY: The Food and Drug cosmetic products are also regulated as
potential for harm to health if used with a Administration (FDA) is announcing drugs.
drug? that a proposed collection of As with other commodities FDA
6. Does the proposed framework information has been submitted to the regulates, the safety of cosmetic
appropriately identify the materials and Office of Management and Budget products can be ensured in part through
information that should be submitted by drug (OMB) for review and clearance under a manufacturer’s approach to the
sponsors as part of a voluntary request for the Paperwork Reduction Act of 1995 management of cosmetic quality. To
comment under § 202.1(j)(4)? Are there other (PRA). date, FDA has not identified in the
materials or information FDA should published literature any systematic,
consider in its evaluation of whether DATES: Fax written comments on the
collection of information by December detailed study of the diversity of the
prescription drug-use-related software output practices and standards employed
submitted by drug sponsors is consistent 20, 2018.
across the cosmetic industry. This study
with FDA-required labeling and is truthful ADDRESSES: To ensure that comments on
is intended to fill this gap. FDA
and not misleading (e.g., human factors study the information collection are received,
proposes to conduct a voluntary survey
results)? OMB recommends that written
of cosmetics establishments to identify
7. Regarding software functions, FDA’s comments be faxed to the Office of
proposed expectation is that sponsors are
the current manufacturing practices in
Information and Regulatory Affairs,
responsible for ensuring that prescription
the cosmetic industry.
OMB, Attn: FDA Desk Officer, Fax: 202– The survey instrument will collect
drug-use-related software reliably produces 395–7285, or emailed to oira_
its output as intended. Is this approach
data, on a voluntary basis, from
submission@omb.eop.gov. All cosmetic product manufacturers on the
sufficient to ensure patient safety? comments should be identified with the
8. FDA recognizes that software will have following topics:
OMB control number 0910—New and • Written Procedures and
frequent updates, many of which will not title ‘‘Survey of Current Manufacturing
alter prescription drug-use-related software Documentation—including written
Practices for the Cosmetics Industry.’’ procedures and records for
functionality. FDA proposes that for Also include the FDA docket number
prescription drug-use-software output that is manufacturing involving personnel, raw
found in brackets in the heading of this materials, processing, cleaning,
considered promotional, if changes in the document.
software do not alter the output experienced maintenance, finished products, and
by the user, FDA would not need to be FOR FURTHER INFORMATION CONTACT: Ila training.
notified of those changes. Does this approach S. Mizrachi, Office of Operations, Food • Buildings and Equipment—
strike an appropriate balance between and Drug Administration, Three White including facility space, pest control,
allowing for software innovation while Flint North, 10A–12M, 11601 practices ensuring the cleanliness and
providing adequate oversight of sponsor Landsdown St., North Bethesda, MD sanitation, water usage and treatment,
communications about their prescription 20852, 301–796–7726, PRAStaff@ and the proper functioning and
drugs? fda.hhs.gov. operation of equipment.
9. What can be done to ensure that the end SUPPLEMENTARY INFORMATION: In • Materials and Manufacturing—
user has access to the prescription drug-use- compliance with 44 U.S.C. 3507, FDA including practices for inventory
related software that is appropriate to the has submitted the following proposed management, labeling and storage of
specific drug dispensed at the pharmacy (e.g., collection of information to OMB for raw materials, closures, and in process
in cases of generic substitution)? review and clearance. materials, and in process standard
10. What issues should the Agency operating procedures.
consider as it develops this proposed Survey of Current Manufacturing • Quality Control/Product Testing—
framework in order to facilitate timely Practices for the Cosmetics Industry including the scope of the quality
generic competition for prescription drugs control unit, laboratory testing, dealing
OMB Control Number 0910—NEW
that are approved with prescription drug-use- with rejected or returned products and
related software output included in the FDA- FDA has the responsibility to protect complaints, and corrective actions.
required labeling? public health and, as part of this broad In addition, FDA will obtain the
Dated: November 14, 2018. mandate, oversees the safety of the characteristics of surveyed
nation’s cosmetic products. The Federal establishments such as the types of
Leslie Kux,
Food, Drug, and Cosmetic Act (FD&C cosmetics produced, published
Associate Commissioner for Policy. Act) prohibits the introduction into standards and guidelines followed, the
[FR Doc. 2018–25206 Filed 11–19–18; 8:45 am] interstate commerce of any cosmetic number of employees, the volume of
BILLING CODE 4164–01–P that is adulterated or misbranded; production, and the approximate
VerDate Sep<11>2014 20:31 Nov 19, 2018 Jkt 247001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1](https://thefederalregister.org/doc/83_FR_58806/page/1.svg)
![Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices 58583
revenue. The survey will be standards employed across the identified in the published literature
administered by web or by mail cosmetics industry. With regard to any systematic, detailed study of the
(respondent choice) and it will be identifying manufacturers who are not diversity of the practices and standards
directed to the Plant Manager of the observing good manufacturing practices, employed across the cosmetic industry
cosmetics establishment. the survey is structured to provide FDA to ensure product quality and safety.’’
This is a new, one-time data with anonymized, updated cosmetic FDA is conducting this survey to fill
collection. FDA does not plan to collect industry information, not individual this gap in knowledge, and this survey
this data from the cosmetics industry on response information about any of its is necessary to achieve this goal. With
an ongoing basis. participants. regard to the survey itself, it is (and has
In the Federal Register of July 2, 2018 The second comment addressed been) available at the FDA Docket
(83 FR 30940), FDA published a 60-day specific PRA issues of necessity, burden assigned to this collection (FDA–2018–
notice requesting public comment on estimate, quality and utility of the N–2027). We agree that the burden is
the proposed collection of information. survey, and method of collection. The likely greater than 30 minutes, and
FDA received three comments. FDA commenter feels that the survey is not based on results of our pretest with six
thanks the commenters for their necessary for proper FDA oversight of individuals, we have increased the
comments and provides our responses the industry because this information is burden estimate to 60 minutes. FDA’s
below. already available to FDA through its contractor did consult with industry
The first comment expressed concern facility inspections. They also indicated stakeholders in the development of the
that the collection was voluntary, and a that they had not seen the actual survey instrument. Finally, FDA thanks
number of manufacturers may not questions on the survey, and therefore the commenter for their comments and
participate, which will not inform FDA felt the burden estimate was not thoughts that our suggested method of
of manufacturers who are not observing feasible. They suggested that FDA web or collection method was
good manufacturing practices. They also partner with outside sources to assist reasonable.
indicated that they feel the survey could FDA in gathering information about the
help set future standards for the industry and thought that web or mail The third comment was not related to
industry. In response to this comment, collection was reasonable. the PRA and will not be addressed at
FDA notes that this survey is being In response to the second comment, this time.
conducted to inform FDA with updated FDA noted in the Federal Register of FDA estimates the burden of this
information about the practices and July 2, 2018 that FDA has ‘‘not collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
Survey Invitation .......................................................... 898 1 898 0.08 (5 minutes) ..... 71.84
Survey .......................................................................... 564 1 564 1 ............................. 564
Total ...................................................................... ........................ ........................ ........................ ................................ 635.84
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We will select a sample of 898 Dated: November 14, 2018. information has been submitted to the
establishments. After adjusting for Leslie Kux, Office of Management and Budget
ineligibility (i.e., firms that do not Associate Commissioner for Policy. (OMB) for review and clearance under
produce cosmetic products and those no [FR Doc. 2018–25231 Filed 11–19–18; 8:45 am] the Paperwork Reduction Act of 1995.
longer in operation) and a response rate BILLING CODE 4164–01–P DATES: Fax written comments on the
of 70 percent, we expect 564 completed collection of information by December
surveys. 20, 2018.
We expect each individual survey DEPARTMENT OF HEALTH AND
HUMAN SERVICES ADDRESSES: To ensure that comments on
invitation to take 5 minutes (0.08 hour)
the information collection are received,
to complete. Multiplying by the 898
Food and Drug Administration OMB recommends that written
establishments that will receive the
[Docket No. FDA 2012–N–0129]
comments be faxed to the Office of
survey invitation, we estimate the time
Information and Regulatory Affairs,
burden of the survey invitation to be
Agency Information Collection OMB, Attn: FDA Desk Officer, Fax: 202–
71.84 hours. Previously, we estimated
Activities; Submission for Office of 395–7285, or emailed to oira_
that the survey would take 30 minutes submission@omb.eop.gov. All
to complete. However, based on our Management and Budget Review;
Comment Request; General Licensing comments should be identified with the
pretest with six individuals, we now OMB control number 0910–0719. Also
expect each individual survey to take, Provisions; Section 351(k) Biosimilar
Applications include the FDA docket number found
on average, 60 minutes (1 hour) to in brackets in the heading of this
complete. Multiplying by the estimated AGENCY: Food and Drug Administration, document.
564 establishments that will complete HHS.
the survey, we estimate the time burden ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
of the survey to be 564 hours. We JonnaLynn Capezzuto, Office of
estimate the total hourly reporting SUMMARY: The Food and Drug Operations, Food and Drug
burden for this collection of information Administration (FDA) is announcing Administration, Three White Flint
to be 635.84 hours. that a proposed collection of North, 10A–12M, 11601 Landsdown St.,
VerDate Sep<11>2014 20:31 Nov 19, 2018 Jkt 247001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1](https://thefederalregister.org/doc/83_FR_58806/page/2.svg)
Document Created: 2018-11-20 07:59:12
Document Modified: 2018-11-20 07:59:12
| 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 December 20, 2018. | |
| 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 | 83 FR 58582 |
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