80 FR 61430 - Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Cosmetic Good Manufacturing Practices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 197 (October 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 197 (October 13, 2015)
| Page Range | 61430-61433 | |
| FR Document | 2015-25957 |
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)] [Notices] [Pages 61430-61433] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25957] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3456] Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Cosmetic Good Manufacturing Practices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including collections of information in current guidance documents, and allow 60 days for public comment. This notice invites comments on the recommended recordkeeping associated with our draft guidance entitled, ``Draft Guidance for Industry: Cosmetic Good Manufacturing Practices.'' Our draft guidance remains unchanged by this notice. We are publishing this notice in compliance with the PRA. This notice does not represent any new regulatory initiative. DATES: Submit either electronic or written comments on the collection of information by December 14, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-N-3456 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Cosmetic Good Manufacturing Practices.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 [[Page 61431]] 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: Under the PRA (44 U.S.C. 3501-3521), 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. 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, including collections of information in current guidance documents, before submitting the collection to OMB for approval. To comply with this requirement, we are publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our 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. Recommended Recordkeeping for Cosmetic Good Manufacturing Practices OMB Control Number 0910-NEW The draft guidance, entitled ``Draft Guidance for Industry: Cosmetic Good Manufacturing Practices,'' (available at http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm353046.htm#Raw) provides guidance to industry and other stakeholders (e.g., consumer interest groups, academia, other regulatory groups) on our current thinking concerning what constitutes Good Manufacturing Practices (GMPs) for cosmetics. It is intended to assist industry and other stakeholders in identifying the standards and issues that can affect the quality of cosmetic products. In addition, as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), we agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when developing the draft guidance. We have incorporated elements of ISO 22716, as appropriate, and that are consistent with our regulations. Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331) prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated or misbranded. Manufacturers of cosmetics can reduce the risk of adulterating or misbranding cosmetics by following the GMP recommendations in the draft guidance. The draft guidance recommends that manufacturers of cosmetics prepare written procedures and maintain records pertaining to: (1) Buildings and facilities; (2) equipment; (3) personnel; (4) raw materials; (5) production; (6) laboratory controls; (7) internal audits; and, (8) complaints, adverse events, and recalls. We expect that manufacturers of cosmetics that choose to follow the recommendations of this Cosmetic GMP draft guidance would maintain records of their written procedures as well as their test methods or other appropriate verification procedures. It is also possible that manufacturers would obtain and maintain records of Certificates of Analysis, test results, or other appropriate verification procedures from their suppliers. GMP is concerned with both manufacturing and quality control procedures. Manufacturers of cosmetics will use their written procedures and records as that part of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use. Records would be compiled and retained at each manufacturing facility. Description of Respondents: The respondents are manufacturers of cosmetic products. Our draft guidance remains unchanged by this notice. We are publishing this notice in compliance with the PRA. This notice does not represent any new regulatory initiative. We estimate the burden of this collection of information as follows: Table 1--Estimated One-Time Burden to Establish Written Procedures \1\ ---------------------------------------------------------------------------------------------------------------- No. of records Average burden Section of draft guidance No. of per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Buildings and Facilities-- 607 1 607 1 607 Development of written procedures regarding maintaining the buildings and facilities used for manufacturing in a clean and orderly manner................. Equipment--Development of 607 1 607 36 21,852 written procedures regarding calibration and maintenance of equipment...................... Personnel--Development of 607 1 607 3.6 2,185 written procedures regarding personnel, including documentation of education, training, and/or experience of personnel, and preventing microbial contamination from sick or infected personnel, and for hygienic practices......... [[Page 61432]] Raw Materials--Development of 607 1 607 10 6,070 written procedures for identifying, storing, examining, testing, inventorying, handling, and controlling raw materials to ensure they conform to appropriate standards and specifications................. Production--Development of 607 1 607 68 41,276 written procedures regarding manufacturing operations....... Laboratory Controls--Development 607 1 607 45 27,315 of written procedures regarding laboratory controls............ Internal Audit--Development of 607 1 607 10.7 6,495 written procedures regarding internal audits................ Complaints, Adverse Events, and 607 1 607 12 7,284 Recalls \2\--Development of written procedures regarding product complaints and consumer adverse events................. Complaints, Adverse Events, and 607 1 607 6 3,642 Recalls \2\--Records regarding returned product............... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 116,726 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ To avoid double-counting, the burden hour analysis in table 1 does not include burden hours already accounted for in the information collection approved under OMB control number 0910-0249 for our recall regulations (21 CFR part 7). Table 2--Estimated Annual Recordkeeping Burden for Records Maintenance \1\ ---------------------------------------------------------------------------------------------------------------- No. of records Average burden Section of draft guidance No. of per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Buildings and Facilities-- 1,518 1 1,518 2 3,036 Records regarding maintaining the buildings and facilities used for manufacturing in a clean and orderly manner....... Equipment--Records regarding 1,518 1 1,518 3.3 5,009 calibration and maintenance of equipment...................... Personnel--Records regarding 1,518 1 1,518 41.1 62,390 personnel, including documentation of education, training and/or experience of personnel, and preventing microbial contamination from sick or infected personnel, and for hygienic practices......... Raw Materials--Records regarding 1,518 1 1,518 231.5 351,417 identifying, storing, examining, testing, inventorying, handling, and controlling raw materials to ensure they conform to appropriate standards and specifications................. Production--Records regarding 1,518 1 1,518 7.7 11,689 manufacturing operations....... Laboratory Controls--Records 1,518 1 1,518 1.2 1,822 regarding laboratory controls.. Internal Audit--Records of 1,518 1 1,518 231.5 351,417 internal audits................ Complaints, Adverse Events, and 1,518 1 1,518 60.3 91,535 Recalls \2\--Records regarding product complaints and consumer adverse events................. Complaints, Adverse Events, and 1,518 1 1,518 5.1 7,742 Recalls \2\--Records regarding returned product............... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 886,057 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ To avoid double-counting, the burden hour analysis in table 1 does not include burden hours already accounted for in the information collection approved under OMB control number 0910-0249 for our recall regulations (21 CFR part 7). In table 1 we list the one-time burdens associated with establishing written procedures. In table 2 we list the annual burdens associated with recordkeeping. We base our estimates of the number of recordkeepers reported in column 2 of tables 1 and 2 on data available to us, our knowledge of and experience with the cosmetics industry, and our communications with industry, as well as our estimate of the number of recordkeepers subject to cosmetic labeling regulations, published in the Federal Register of June 25, 2014 (79 FR 36069). We estimate there are 1,518 cosmetic product establishments in the United States (79 FR 36069 at 36070). We estimate that 20 percent of these (304 establishments) are large businesses and 80 percent (1,214 establishments) are small businesses. We further estimate that large businesses are likely to have established written procedures and that about half of the small businesses (607 establishments) may not have established written procedures. Thus, for purposes of this analysis, we assume that these 607 establishments will undertake to establish written procedures recommended by the draft guidance, when it is finalized, as reported in table 1, column 2. We [[Page 61433]] further assume that the 1,518 cosmetic product establishments may not maintain all of the records recommended by the draft guidance. Thus, for purposes of this analysis, we assume that 1,518 establishments will keep the records recommended by the draft guidance, when it is finalized, as reported in table 2, column 2. We further assume that if multiple products are produced in the same facility, the written procedures and recordkeeping will be shared among the multiple products. We base our estimates of the number of records per recordkeeper and the average burden per recordkeeping reported in columns 3 and 5 of tables 1 and 2 on our experience with good manufacturing practices used to control the identity and composition of food and dietary supplements and to limit contaminants and prevent adulteration, as well as our estimate of the burden of similar recordkeeping activities described in the dietary supplement final rule published in the Federal Register of June 25, 2007 (72 FR 34752 at 34916) (the June 25, 2007, final rule), that established, in part 111 (21 CFR part 111), the minimum good manufacturing practices necessary for dietary supplements. For the recordkeeping recommendations listed in table 2, the recordkeeping occasions consist of frequent brief entries of dates, temperatures, monitoring results, or documentation that specific actions were taken. Information might be recorded a few times a day, week, or month. Because the records burden involves frequent brief entries, we did not attempt to estimate the actual number of recordkeeping occasions for these activities. We entered one as the default for the number of records per recordkeeper and we calculated the average burden per recordkeeping in column 5 based on the reported burden of similar provisions estimated in the June 25, 2007, final rule, averaged across the 1,460 firms covered by that final rule. The estimates for the recordkeeping burdens presented here are averages. We anticipate that the time spent to develop written procedures and recordkeeping would vary based on the type of cosmetic product manufactured. The estimated burdens for developing recordkeeping includes record maintenance, periodically reviewing records to determine if they may be discarded, and any associated documentation for that activity. This draft guidance also refers to previously approved collections of information found in our regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 3501-3521). The collections of information in our recall regulations in 21 CFR part 7 have been approved under OMB control number 0910-0249. The collection of information in 21 CFR 70.25, which requires that color additives subject to certification be labeled with the lot number assigned by the Color Certification Branch, has been approved under OMB control number 0910-0016. Dated: October 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25957 Filed 10-9-15; 8:45 am] BILLING CODE 4164-01-P
![61430 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
TABLE 1—Continued
Application No. Drug Applicant
ANDA 089238 ......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318.
mg/30 mg.
ANDA 089244 ......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Do.
mg/60 mg.
ANDA 089423 ......... Amitriptyline HCl Tablets USP, 150 mg ................................ Mutual Pharmaceutical Co., Inc.
ANDA 090849 ......... Oxaliplatin for Injection USP, 50 mg/vial and 100 mg/vial .... Sandoz Inc., 506 Carnegie Center, Suite 400, Princeton,
NJ 08540.
Therefore, under section 505(e) of the information, including collections of Dockets Management (HFA–305), Food
Federal Food, Drug, and Cosmetic Act information in current guidance and Drug Administration, 5630 Fishers
(21 U.S.C. 355(e)) and under authority documents, and allow 60 days for Lane, Rm. 1061, Rockville, MD 20852.
delegated to the Director of Food and public comment. This notice invites • For written/paper comments
Drugs, Center for Drug Evaluation and comments on the recommended submitted to the Division of Dockets
Research, by the Commissioner, recordkeeping associated with our draft Management, FDA will post your
approval of the applications listed in guidance entitled, ‘‘Draft Guidance for comment, as well as any attachments,
table 1 in this document, and all Industry: Cosmetic Good Manufacturing except for information submitted,
amendments and supplements thereto, Practices.’’ Our draft guidance remains marked, and identified, as confidential,
is hereby withdrawn, effective unchanged by this notice. We are if submitted as detailed in
November 12, 2015. Introduction or publishing this notice in compliance ‘‘Instructions.’’
delivery for introduction into interstate with the PRA. This notice does not Instructions: All submissions received
commerce of products without represent any new regulatory initiative. must include the Docket No. FDA–
approved new drug applications DATES: Submit either electronic or 2015–N–3456 for ‘‘Agency Information
violates section 301(a) and (d) of the Act written comments on the collection of Collection Activities; Proposed
(21 U.S.C. 331(a) and (d)). Drug information by December 14, 2015. Collection; Comment Request;
products that are listed in table 1 that ADDRESSES: You may submit comments
Recommended Recordkeeping for
are in inventory on the date that this as follows: Cosmetic Good Manufacturing
notice becomes effective (see the DATES Practices.’’ Received comments will be
section) may continue to be dispensed Electronic Submissions placed in the docket and, except for
until the inventories have been depleted Submit electronic comments in the those submitted as ‘‘Confidential
or the drug products have reached their following way: Submissions,’’ publicly viewable at
expiration dates or otherwise become • Federal eRulemaking Portal: http:// http://www.regulations.gov or at the
violative, whichever occurs first. www.regulations.gov. Follow the Division of Dockets Management
Dated: October 6, 2015. instructions for submitting comments. between 9 a.m. and 4 p.m., Monday
Comments submitted electronically, through Friday.
Leslie Kux, • Confidential Submissions—To
Associate Commissioner for Policy.
including attachments, to http://
www.regulations.gov will be posted to submit a comment with confidential
[FR Doc. 2015–25922 Filed 10–9–15; 8:45 am] information that you do not wish to be
the docket unchanged. Because your
BILLING CODE 4164–01–P
comment will be made public, you are made publicly available, submit your
solely responsible for ensuring that your comments only as a written/paper
comment does not include any submission. You should submit two
DEPARTMENT OF HEALTH AND copies total. One copy will include the
HUMAN SERVICES confidential information that you or a
third party may not wish to be posted, information you claim to be confidential
such as medical information, your or with a heading or cover note that states
Food and Drug Administration
anyone else’s Social Security number, or ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2015–N–3456] confidential business information, such CONFIDENTIAL INFORMATION’’. The
as a manufacturing process. Please note Agency will review this copy, including
Agency Information Collection the claimed confidential information, in
Activities; Proposed Collection; that if you include your name, contact
information, or other information that its consideration of comments. The
Comment Request; Recommended second copy, which will have the
Recordkeeping for Cosmetic Good identifies you in the body of your
comments, that information will be claimed confidential information
Manufacturing Practices redacted/blacked out, will be available
posted on http://www.regulations.gov.
AGENCY: Food and Drug Administration, • If you want to submit a comment for public viewing and posted on
HHS. with confidential information that you http://www.regulations.gov. Submit
ACTION: Notice. do not wish to be made available to the both copies to the Division of Dockets
public, submit the comment as a Management. If you do not wish your
SUMMARY: The Food and Drug written/paper submission and in the name and contact information to be
mstockstill on DSK4VPTVN1PROD with NOTICES
Administration (FDA or we) is manner detailed (see ‘‘Written/Paper made publicly available, you can
announcing an opportunity for public Submissions’’ and ‘‘Instructions’’). provide this information on the cover
comment on our proposed collection of sheet and not in the body of your
certain information. Under the Written/Paper Submissions comments and you must identify this
Paperwork Reduction Act of 1995 (the Submit written/paper submissions as information as ‘‘confidential.’’ Any
PRA), Federal Agencies must publish a follows: information marked as ‘‘confidential’’
notice in the Federal Register • Mail/Hand delivery/Courier (for will not be disclosed except in
concerning each proposed collection of written/paper submissions): Division of accordance with 21 CFR 10.20 and other
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![Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 61433
further assume that the 1,518 cosmetic subject to review by the Office of Comments submitted electronically,
product establishments may not Management and Budget (OMB) under including attachments, to http://
maintain all of the records the PRA (44 U.S.C. 3501–3521). The www.regulations.gov will be posted to
recommended by the draft guidance. collections of information in our recall the docket unchanged. Because your
Thus, for purposes of this analysis, we regulations in 21 CFR part 7 have been comment will be made public, you are
assume that 1,518 establishments will approved under OMB control number solely responsible for ensuring that your
keep the records recommended by the 0910–0249. The collection of comment does not include any
draft guidance, when it is finalized, as information in 21 CFR 70.25, which confidential information that you or a
reported in table 2, column 2. We requires that color additives subject to third party may not wish to be posted,
further assume that if multiple products certification be labeled with the lot such as medical information, your or
are produced in the same facility, the number assigned by the Color anyone else’s Social Security number, or
written procedures and recordkeeping Certification Branch, has been approved confidential business information, such
will be shared among the multiple under OMB control number 0910–0016. as a manufacturing process. Please note
products. Dated: October 7, 2015.
that if you include your name, contact
We base our estimates of the number information, or other information that
of records per recordkeeper and the Leslie Kux,
identifies you in the body of your
average burden per recordkeeping Associate Commissioner for Policy. comments, that information will be
reported in columns 3 and 5 of tables 1 [FR Doc. 2015–25957 Filed 10–9–15; 8:45 am] posted on http://www.regulations.gov.
and 2 on our experience with good BILLING CODE 4164–01–P • If you want to submit a comment
manufacturing practices used to control with confidential information that you
the identity and composition of food do not wish to be made available to the
and dietary supplements and to limit DEPARTMENT OF HEALTH AND public, submit the comment as a
contaminants and prevent adulteration, HUMAN SERVICES written/paper submission and in the
as well as our estimate of the burden of manner detailed (see ‘‘Written/Paper
similar recordkeeping activities Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
described in the dietary supplement [Docket No. FDA–2015–N–3543]
Written/Paper Submissions
final rule published in the Federal
Register of June 25, 2007 (72 FR 34752 Agency Information Collection Submit written/paper submissions as
at 34916) (the June 25, 2007, final rule), Activities; Proposed Collection; follows:
that established, in part 111 (21 CFR Comment Request; Quantitative • Mail/Hand delivery/Courier (for
part 111), the minimum good Information in Direct-to-Consumer written/paper submissions): Division of
manufacturing practices necessary for Television Advertisements Dockets Management (HFA–305), Food
dietary supplements. For the and Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
recordkeeping recommendations listed
in table 2, the recordkeeping occasions HHS. • For written/paper comments
consist of frequent brief entries of dates, ACTION: Notice. submitted to the Division of Dockets
temperatures, monitoring results, or Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments,
documentation that specific actions
Administration (FDA) is announcing an except for information submitted,
were taken. Information might be
opportunity for public comment on the marked and identified, as confidential,
recorded a few times a day, week, or
proposed collection of certain if submitted as detailed in
month. Because the records burden
information by the Agency. Under the ‘‘Instructions.’’
involves frequent brief entries, we did
Paperwork Reduction Act of 1995 (the Instructions: All submissions received
not attempt to estimate the actual
PRA), Federal Agencies are required to must include the Docket No. FDA–
number of recordkeeping occasions for
publish notice in the Federal Register 2015–N–3543 for ‘‘Agency Information
these activities. We entered one as the
concerning each proposed collection of Collection Activities; Proposed
default for the number of records per
information and to allow 60 days for Collection; Comment Request;
recordkeeper and we calculated the
public comment in response to the Quantitative Information in Direct-to-
average burden per recordkeeping in
column 5 based on the reported burden notice. This notice solicits comments on Consumer Television Advertisements.’’
of similar provisions estimated in the research entitled ‘‘Quantitative Received comments will be placed in
June 25, 2007, final rule, averaged Information in Direct-to-Consumer the docket and, except for those
across the 1,460 firms covered by that Television Advertisements.’’ The submitted as ‘‘Confidential
final rule. objective of this research is to test Submissions,’’ publicly viewable at
The estimates for the recordkeeping consumers’ understanding of http://www.regulations.gov or at the
burdens presented here are averages. We quantitative information about Division of Dockets Management
anticipate that the time spent to develop prescription drugs in DTC television between 9 a.m. and 4 p.m., Monday
written procedures and recordkeeping advertisements (ads). through Friday.
would vary based on the type of DATES: Submit either electronic or • Confidential Submissions—To
cosmetic product manufactured. The written comments on the collection of submit a comment with confidential
estimated burdens for developing information by December 14, 2015. information that you do not wish to be
recordkeeping includes record ADDRESSES: You may submit comments made publicly available, submit your
mstockstill on DSK4VPTVN1PROD with NOTICES
maintenance, periodically reviewing as follows: comments only as a written/paper
records to determine if they may be submission. You should submit two
discarded, and any associated Electronic Submissions copies total. One copy will include the
documentation for that activity. Submit electronic comments in the information you claim to be confidential
This draft guidance also refers to following way: with a heading or cover note that states
previously approved collections of • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
information found in our regulations. www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
These collections of information are instructions for submitting comments. Agency will review this copy, including
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Document Created: 2018-02-27 08:48:00
Document Modified: 2018-02-27 08:48:00
| 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 December 14, 2015. | |
| 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 | 80 FR 61430 |
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