83 FR 55896 - Agency Information Collection Activities; Proposed Collection; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 217 (November 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 217 (November 8, 2018)
| Page Range | 55896-55898 | |
| FR Document | 2018-24441 |
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)] [Notices] [Pages 55896-55898] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24441] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3442] Agency Information Collection Activities; Proposed Collection; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a pilot study entitled ``Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.'' DATES: Submit either electronic or written comments on the collection of information by January 7, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 7, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-3442 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. [[Page 55897]] Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States; OMB Control Number 0910--New I. Background In the past 40 years, the cosmetics industry, as well as consumer behaviors and expectations related to cosmetics, have evolved. Technological and scientific advances have been made in cosmetics production, manufacturing, marketing, and usage, while consumer access to information about cosmetic products and ingredients has expanded, because of the internet and social media influences. Most notably, multiple cosmetic products such as lotions, perfume, body wash, hand wash, shampoo, deodorant, hair spray, baby wipes, nail polish, etc. are used daily by nearly everyone in the United States, including infants, children, adults, geriatric populations, healthy people, and individuals with medical conditions. Evidence indicates that the prevalence of allergies in the U.S. population is increasing (Ref. 1). However, no publicly available data has been collected on the prevalence of adverse reactions to cosmetic products since 1975 (Ref. 2). FDA proposes a pilot study to collect the data needed for a current and detailed understanding of the impact of allergens on consumer use of cosmetics. In addition to updating our knowledge about cosmetics, this new information collection is consistent with FDA's efforts to improve public awareness of adverse events associated with FDA-regulated products. In December 2016, FDA decided to make public the adverse event data in the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS). CAERS (and its imminent successor the CFSAN Adverse Events Management System or CAEMS) provides the public with transparent access to all food and cosmetic related adverse events reported to FDA. However, the information that we have collected and which will be collected through CAERS is an underestimate of adverse events to cosmetics in the United States, as not every adverse event is reported by consumers through CAERS because some consumers are not aware of CAERS or some choose not to report. To obtain additional relevant data, FDA proposes to conduct a pilot study. ``Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.'' The objective of the current effort is to collect information needed for a more current understanding of the prevalence of adverse reactions to cosmetics. FDA proposes to conduct an exploratory consumer web-based survey to collect data on consumer use of cosmetic products, the frequency of adverse events believed to be caused by allergens in cosmetics, consumer awareness of the problem, and actions (if any) taken to avoid the allergens. The proposed survey will use a 20-minute web-based questionnaire to collect information from 1,000 English-speaking adult members of a probability-based web-enabled research panel maintained by a contractor. Selected panel members will be sent an email invitation to participate in the survey. After clicking on the link in the email invitation, panelists will be directed to the online instrument. On the first screen, panelists will provide disclosure information which includes informed consent and be asked if they would like to proceed with the survey. Consenting respondents will be prompted to complete the survey. After OMB approval of this collection and prior to the full-scale survey, a pretest will be conducted with 100 respondents randomly selected from the panel. The web-based panel is designed to be representative of the U.S. adult population. This representation is achieved through address-based sampling where every U.S. adult with an address (including those who do not have a landline phone number) has an equal probability of being selected for participation. This pilot study is part of the Agency's continuing effort to understand the impact of allergens on cosmetics. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Study component Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Pretest invitation............ 200 1 200 0.033 (2 7 minutes). Pretest....................... 100 1 100 0.333 (20 33 minutes). Survey invitation............. 1,667 1 1,667 0.033 (2 55 minutes). Survey........................ 1,000 1 1,000 0.333 (20 333 minutes). ------------------------------------------------ --------------- Total..................... .............. .............. .............. ................ 428 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 55898]] II. References The following references are on display with the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these are not available electronically at https://www.regulations.gov as these references are copyright protected. 1. Peiser, M., T. Traulau, J. Heidler, et al., ``Allergic Contact Dermatitis: Epidemiology, Molecular Mechanisms, In Vitro Methods and Regulatory Aspects. Current Knowledge Assembled at an International Workshop at BfR, Germany.'' Cellular and Molecular Life Sciences, 69:763-781, 2012. 2. Westat, Inc. ``An Investigation of Consumers' Perceptions of Adverse Reactions to Cosmetic Products.'' Final report submitted to U.S. Department of Health, Education, and Welfare, Food and Drug Administration. June 1975. Dated: November 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24441 Filed 11-7-18; 8:45 am] BILLING CODE 4164-01-P
![55896 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
approach to data exchange? This might at the end of January 7, 2019. Comments a.m. and 4 p.m., Monday through
include timing (procurement, fiscal received by mail/hand delivery/courier Friday.
year, or legislative cycles), cost, (for written/paper submissions) will be • Confidential Submissions—To
availability of required expertise, considered timely if they are submit a comment with confidential
needed regulatory change, impacts on postmarked or the delivery service information that you do not wish to be
current practices, etc. acceptance receipt is on or before that made publicly available, submit your
5. If a more standards-based approach date. comments only as a written/paper
to data exchange were adopted, what submission. You should submit two
Electronic Submissions copies total. One copy will include the
kinds of technical assistance or training
would you anticipate needing, if any? Submit electronic comments in the information you claim to be confidential
ACF appreciates any and all following way: with a heading or cover note that states
comments on the above questions, or • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
related recommendations. Comments https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
will be considered carefully and used to instructions for submitting comments. Agency will review this copy, including
inform the development of a planned Comments submitted electronically, the claimed confidential information, in
Notice of Proposed Rulemaking, which including attachments, to https:// its consideration of comments. The
is anticipated to be published in the www.regulations.gov will be posted to second copy, which will have the
spring of 2019. the docket unchanged. Because your claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
Dated: October 25, 2018.
solely responsible for ensuring that your for public viewing and posted on
Lynn A. Johnson,
comment does not include any https://www.regulations.gov. Submit
Assistant Secretary for Children and Families. confidential information that you or a both copies to the Dockets Management
[FR Doc. 2018–24459 Filed 11–7–18; 8:45 am] third party may not wish to be posted, Staff. If you do not wish your name and
BILLING CODE 4184–79–P such as medical information, your or contact information to be made publicly
anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
DEPARTMENT OF HEALTH AND as a manufacturing process. Please note in the body of your comments and you
HUMAN SERVICES that if you include your name, contact must identify this information as
information, or other information that ‘‘confidential.’’ Any information marked
Food and Drug Administration
identifies you in the body of your as ‘‘confidential’’ will not be disclosed
[Docket No. FDA–2018–N–3442] comments, that information will be except in accordance with 21 CFR 10.20
posted on https://www.regulations.gov. and other applicable disclosure law. For
Agency Information Collection • If you want to submit a comment more information about FDA’s posting
Activities; Proposed Collection; with confidential information that you of comments to public dockets, see 80
Comment Request; Web-Based Pilot do not wish to be made available to the FR 56469, September 18, 2015, or access
Survey To Assess Allergy to public, submit the comment as a the information at: https://www.gpo.gov/
Cosmetics in the United States written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper 23389.pdf.
HHS. Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
ACTION: Notice. Written/Paper Submissions read background documents or the
electronic and written/paper comments
SUMMARY: The Food and Drug Submit written/paper submissions as received, go to https://
Administration (FDA or Agency) is follows: www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
announcing an opportunity for public
written/paper submissions): Dockets heading of this document, into the
comment on the proposed collection of
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
certain information by the Agency.
Drug Administration, 5630 Fishers and/or go to the Dockets Management
Under the Paperwork Reduction Act of
Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
1995 (PRA), Federal Agencies are • For written/paper comments
required to publish notice in the Rockville, MD 20852.
submitted to the Dockets Management
Federal Register concerning each Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
proposed collection of information and well as any attachments, except for Domini Bean, Office of Operations,
to allow 60 days for public comment in information submitted, marked and Food and Drug Administration, Three
response to the notice. This notice identified, as confidential, if submitted White Flint North, 10A–12M, 11601
solicits comments on a pilot study as detailed in ‘‘Instructions.’’ Landsdown St., North Bethesda, MD
entitled ‘‘Web-based Pilot Survey to Instructions: All submissions received 20852, 301–796–5733, PRAStaff@
Assess Allergy to Cosmetics in the must include the Docket No. FDA– fda.hhs.gov.
United States.’’ 2018–N–3442 for ‘‘Agency Information SUPPLEMENTARY INFORMATION: Under the
DATES: Submit either electronic or Collection Activities; Proposed PRA (44 U.S.C. 3501–3520), Federal
written comments on the collection of Collection; Comment Request; Web- Agencies must obtain approval from the
information by January 7, 2019. based Pilot Survey to Assess Allergy to Office of Management and Budget
ADDRESSES: You may submit comments Cosmetics in the United States.’’ (OMB) for each collection of
daltland on DSKBBV9HB2PROD with NOTICES
as follows. Please note that late, Received comments, those filed in a information they conduct or sponsor.
untimely filed comments will not be timely manner (see ADDRESSES), will be ‘‘Collection of information’’ is defined
considered. Electronic comments must placed in the docket and, except for in 44 U.S.C. 3502(3) and 5 CFR
be submitted on or before January 7, those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
2019. The https://www.regulations.gov Submissions,’’ publicly viewable at or requirements that members of the
electronic filing system will accept https://www.regulations.gov or at the public submit reports, keep records, or
comments until 11:59 p.m. Eastern Time Dockets Management Staff between 9 provide information to a third party.
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![55898 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
II. References in brackets in the heading of this salvages a drug, or an animal feed
The following references are on document. bearing or containing a new animal
display with the Dockets Management FOR FURTHER INFORMATION CONTACT:
drug, that is imported or offered for
Staff (see ADDRESSES) and are available JonnaLynn Capezzuto, Office of import into the United States. When
for viewing by interested persons Operations, Food and Drug operations are conducted at more than
between 9 a.m. and 4 p.m., Monday Administration, Three White Flint one establishment and common
through Friday; these are not available North, 10A–12M, 11601 Landsdown St., ownership and control among all the
electronically at https:// North Bethesda, MD 20852, 301–796– establishments exists, the parent,
www.regulations.gov as these references 3794, PRAStaff@fda.hhs.gov. subsidiary, or affiliate company may
submit registration information for all
are copyright protected. SUPPLEMENTARY INFORMATION: In
establishments.
1. Peiser, M., T. Traulau, J. Heidler, et al., compliance with 44 U.S.C. 3507, FDA Private label distributors who do not
‘‘Allergic Contact Dermatitis: Epidemiology, has submitted the following proposed also manufacture, repack, relabel, or
Molecular Mechanisms, In Vitro Methods collection of information to OMB for salvage drugs are not required to register
and Regulatory Aspects. Current Knowledge review and clearance. under part 207. FDA will accept
Assembled at an International Workshop at
BfR, Germany.’’ Cellular and Molecular Life Registration of Producers of Drugs and registration or listing information
Sciences, 69:763–781, 2012. Listing of Drugs in Commercial submitted by a private label distributor
2. Westat, Inc. ‘‘An Investigation of Distribution—21 CFR Part 207; OMB only if it is acting as an authorized agent
Consumers’ Perceptions of Adverse Reactions Control Number 0910–0045—Extension for and submitting information that
to Cosmetic Products.’’ Final report pertains to an establishment that
submitted to U.S. Department of Health, This information collection supports manufactures, repacks, relabels, or
Education, and Welfare, Food and Drug FDA’s drug establishment registration salvages drugs.
Administration. June 1975. and listing regulations and associated Under § 207.21, domestic
guidance intended to assist respondents manufacturers, domestic repackers,
Dated: November 5, 2018. in this regard. Requirements for drug domestic relabelers, and domestic drug
Leslie Kux, establishment registration and drug product salvagers must complete initial
Associate Commissioner for Policy. listing are set forth in section 510 of the registration of each establishment no
[FR Doc. 2018–24441 Filed 11–7–18; 8:45 am] Federal Food, Drug, and Cosmetic Act later than 5 calendar days after
BILLING CODE 4164–01–P (FD&C Act) (21 U.S.C. 360), and section beginning to manufacture, repack,
351 of the Public Health Service Act (42 relabel, or salvage a drug. In addition,
U.S.C. 262). Section 224 of the Food and foreign manufacturers, foreign
DEPARTMENT OF HEALTH AND Drug Administration Amendments Act repackers, foreign relabelers, and foreign
HUMAN SERVICES of 2007 (Pub. L. 110–85) amended drug product salvagers must register
section 510(p) of the FD&C Act to each establishment before the drug is
Food and Drug Administration require electronic drug establishment imported or offered for import into the
[Docket No. FDA–2011–N–0742] registration and drug listing. United States.
Regulations implementing these The information that must be
Agency Information Collection provisions are established under part provided to FDA for registration is
Activities; Submission for Office of 207 (21 CFR part 207). Except as described in § 207.25 and includes the
Management and Budget Review; provided in § 207.65, all information following: (1) Name of the owner or
Comment Request; Registration of submitted must be transmitted to FDA operator of each establishment; if a
Producers of Drugs and Listing of in electronic format by using our partnership, the name of each partner; if
Drugs in Commercial Distribution electronic drug registration and listing a corporation, the name of each
system, in a form that we can process, corporate officer and director, and the
AGENCY: Food and Drug Administration, review, and archive. Establishment place of incorporation; (2) each
HHS. registration information helps FDA establishment’s name, physical address,
ACTION: Notice. identify who is manufacturing, and telephone number(s); (3) all name(s)
repacking, relabeling, and salvaging of the establishment, including names
SUMMARY: The Food and Drug under which the establishment
drugs and where those operations are
Administration (FDA) is announcing conducts business or names by which
performed. Drug listing information
that a proposed collection of the establishment is known; (4)
gives FDA a current inventory of drugs
information has been submitted to the registration number of each
manufactured, repacked, relabeled, or
Office of Management and Budget establishment, if previously assigned by
salvaged for commercial distribution.
(OMB) for review and clearance under FDA; (5) a Unique Facility Identifier in
Both types of information facilitate
the Paperwork Reduction Act of 1995. accordance with the system specified
implementation and enforcement of the
DATES: Fax written comments on the FD&C Act and are used for many under section 510 of the FD&C Act; (6)
collection of information by December important public health purposes. all types of operations performed at
10, 2018. each establishment; (7) name, mailing
ADDRESSES: To ensure that comments on I. Registration Under Part 207 address, telephone number, and email
the information collection are received, Unless otherwise exempt under address of the official contact for the
OMB recommends that written section 510(g) of the FD&C Act or establishment, as provided in
comments be faxed to the Office of § 207.13, all manufacturers, repackers, § 207.69(a); and (8) additionally, with
daltland on DSKBBV9HB2PROD with NOTICES
Information and Regulatory Affairs, relabelers, and salvagers must register respect to foreign establishments subject
OMB, Attn: FDA Desk Officer, Fax: 202– each domestic establishment that to registration, the name, mailing
395–7285, or emailed to oira_ manufactures, repacks, relabels, or address, telephone number, and email
submission@omb.eop.gov. All salvages a drug, or an animal feed address must be provided for: (a) The
comments should be identified with the bearing or containing a new animal U.S. agent, as provided in § 207.69(b);
OMB control number 0910–0045. Also drug, and each foreign establishment (b) each importer in the United States of
include the FDA docket number found that manufactures, repacks, relabels, or drugs manufactured, repacked,
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Document Created: 2018-11-08 06:23:34
Document Modified: 2018-11-08 06:23:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by January 7, 2019. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 55896 |
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