83 FR 7728 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 36 (February 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 36 (February 22, 2018)
| Page Range | 7728-7732 | |
| FR Document | 2018-03608 |
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)] [Notices] [Pages 7728-7732] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03608] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1048] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Medical Device Labeling Regulations. DATES: Submit either electronic or written comments on the collection of information by April 23, 2018. 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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 2018. 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 [[Page 7729]] 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-2014-N-1048 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations.'' 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: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: 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. 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 each proposed extension of an existing 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. Medical Device Labeling Regulations--21 CFR parts 800, 801, and 809 OMB Control Number 0910-0485--Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), among other things, establishes requirements for the label or labeling of a medical device so that it is not misbranded and subject to a regulatory action. Certain provisions under section 502 of the FD&C Act require manufacturers, importers, and distributors of medical devices to disclose information about themselves or the devices on the labels or labeling for the devices. Section 502(b) of the FD&C Act requires that for packaged devices, the label must bear the name and place of business of the manufacturer, packer, or distributor; and an accurate statement of the quantity of the contents. Section 502(f) of the FD&C Act requires that the labeling for a device must contain adequate directions for use. FDA may, however, grant an exemption if the Agency determines that the adequate directions for use labeling requirements are not necessary for the particular case as it relates to protection of the public health. FDA regulations under parts 800, 801, and 809 (21 CFR parts 800, 801, and 809) require disclosure of specific information by manufacturers, importers, and distributors of medical devices about themselves or the devices, on the label or labeling for the devices, to health professionals and consumers. Most of the regulations under parts 800, 801, and 809 are derived from requirements of section 502 of the FD&C Act. Section 502 provides, in part, that a device shall be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the device, is false or misleading in any particular way, or fails to contain adequate directions for use. Recordkeeping Burden Section 801.150(a)(2) establishes recordkeeping requirements for manufacturers of devices to retain a copy of the agreement containing the specifications for the processing, labeling, or repacking of the device for 2 years after the final shipment or delivery of the device. Section 801.150(a)(2) also requires that the subject respondents make copies of this [[Page 7730]] agreement available for inspection at any reasonable hour to any officer or employee of the Department of Health and Human Services (HHS) who requests them. Section 801.410(e) requires copies of invoices, shipping documents, and records of sale or distribution of all impact resistant lenses, including finished eyeglasses and sunglasses, be maintained for 3 years by the retailer and made available upon request by any officer or employee of FDA or by any other officer or employee acting on behalf of the Secretary of HHS. Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years. Section 801.421(d) establishes requirements for hearing aid dispensers to retain copies of all physician statements or any waivers of medical evaluation for 3 years after dispensing the hearing aid. Section 801.430(f) requires manufacturers of menstrual tampons to devise and follow an ongoing sampling plan for measuring the absorbency of menstrual tampons. In addition, manufacturers must use the method and testing parameters described in Sec. 801.430(f). Section 801.435(g) requires latex condom manufacturers to document and provide, upon request, an appropriate justification for the application of the testing data from one product on any variation of that product to support expiration dating in the user labeling. Third-Party Disclosure Burden Sections 800.10(a)(3) and 800.12(c) require that the label for contact lens cleaning solutions bear a prominent statement alerting consumers of the tamper-resistant feature. Further, Sec. 800.12 requires that packaged contact lens cleaning solutions contain a tamper-resistant feature to prevent malicious adulteration. Section 800.10(b)(2) requires that the labeling for liquid ophthalmic preparations packed in multiple-dose containers provide information on the duration of use and the necessary warning information to afford adequate protection from contamination during use. Section 801.1 requires that the label for a device in package form contain the name and place of business of the manufacturer, packer, or distributor. Section 801.5 requires that labeling for a device include information on intended use as defined under Sec. 801.4 and provide adequate directions to assure safe use by the lay consumers. Section 801.61 requires that the principal display panel of an over-the-counter (OTC) device in package form must bear a statement of the identity of the device. The statement of identity of the device must include the common name of the device followed by an accurate statement of the principal intended actions of the device. Section 801.62 requires that the label for an OTC device in package form shall bear a declaration of the net quantity of contents. The label must express the net quantity in terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size. Section 801.109 establishes labeling requirements for prescription devices, in which the label for the device must describe the application or use of the device and contain a cautionary statement restricting the device for sale by, or on the order of, an appropriate professional. Section 801.110 establishes labeling requirements for a prescription device delivered to the ultimate purchaser or user, by a licensed practitioner. The device must be accompanied by labeling bearing the name and address of the licensed practitioner, directions for use, and cautionary statements, if any, provided by the order. Section 801.150(e) requires a written agreement between firms involved in the assembling or packaging of a nonsterile device containing labeling that identifies the final finished device as sterile and then shipping such device in interstate commerce prior to sterilization. In addition, Sec. 801.150(e) requires that each pallet, carton, or other designated unit be conspicuously marked to show its nonsterile nature when introduced into interstate commerce and while being held prior to sterilization. When both requirements are met, FDA will take no regulatory action against the device as being misbranded or adulterated. Section 801.405(b)(1) provides for labeling requirements for articles, including repair kits, re-liners, pads, and cushions, intended for use in temporary repairs and refitting of dentures for lay persons. Section 801.405(b)(1) also requires that the labeling contain the word ``emergency'' preceding and modifying each indication-for-use statement for denture repair kits, and the word ``temporary'' preceding and modifying each indication-for-use statement for re-liners, pads, and cushions. Section 801.405(c) provides for labeling requirements that contain essentially the same information described under Sec. 801.405(b)(1). The information is intended to enable a lay person to understand the limitations of using OTC denture repair kits and denture re-liners, pads, and cushions. Section 801.420(c)(1) requires that manufacturers or distributors of hearing aids develop a user instructional brochure to be provided by the dispenser of the hearing aid to prospective users. The brochure must contain detailed information on the use and maintenance of the hearing aid. Section 801.420(c)(4) establishes requirements that the user instructional brochure or separate labeling provide for technical data elements useful for selecting, fitting, and checking the performance of a hearing aid. In addition, Sec. 801.420(c)(4) provides for testing requirements to determine that the required data elements must be conducted in accordance with the American National Standards Institute (ANSI) ``Specification of Hearing Aid Characteristics,'' ANSI S3.22- 2003 (Revision of ANSI S3.22-1996), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Section 801.421(b) establishes requirements for the hearing aid dispenser to provide prospective users with a copy of the user instructional brochure along with an opportunity to review content, either orally or by the predominant method of communication used during the sale. Section 801.421(c) establishes requirements for the hearing aid dispenser to provide a copy of the user instructional brochure to the prospective purchaser of any hearing aid upon request, or, if the brochure is unavailable, provide the name and address of the manufacturer or distributor from which it may be obtained. Section 801.430(d) establishes labeling requirements for menstrual tampons to provide information on signs, risk factors, and ways to reduce the risk of Toxic Shock Syndrome (TSS). Section 801.430(e)(2) requires menstrual tampon package labels to provide information on the ranges of absorbency and absorbency term based on testing required under Sec. 801.430(f) and an explanation of selecting absorbencies that reduce the risk of contracting TSS. Section 801.435(b), (c), and (h) establishes requirements for condom labeling to bear an expiration date that is supported by testing that demonstrates the integrity of three random lots of the product. Section 809.10(a) and (b) establishes requirements that a label for an in vitro [[Page 7731]] diagnostic (IVD) device and the accompanying labeling (package insert) must contain information identifying its intended use, instructions for use, lot or control number, and source. Section 809.10(d) provides that the labeling requirements for general purpose laboratory reagents may be exempt from the requirements of Sec. 809.10(a) and (b) if the labeling contains information to include, identifying its intended use, instructions for use, lot or control number, and source. Section 809.10(e) provides that the labeling for ``Analyte Specific Reagents'' (ASRs) shall provide information to include, identifying the quantity, proportion, or concentration of each reagent ingredient, instructions for use, lot or control number, and source. Section 809.10(f) provides that the labeling for OTC test sample collection systems for drugs of abuse shall include, among other things, information on the intended use, specimen collection instructions, identification system, and information about use of the test results. Section 809.30(d) requires that advertising and promotional materials for ASRs include the identity and purity of the ASR and the identity of the analyte. Section 1040.20(d) (21 CFR 1040.20) provides that manufacturers of sunlamp products and ultraviolet lamps are subject to the labeling regulations under part 801. The burden estimates are based on FDA's current registration and listing data and shipment information. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity/21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Processing, labeling, or repacking 6,331 887 5,615,597 .5 (30 minutes).................... 2,807,799 agreement--801.150(a)(2). Impact resistant lenses; invoices, 1,119 47,050 52,648,950 0.0008 (.05 minutes)............... 42,119 shipping documents, and records of sale or distribution--801.410(e) and (f). Hearing aid records--801.421(d)....... 10,000 160 1,600,000 .25 (15 minutes)................... 400,000 Menstrual tampons, sampling plan for 16 11 176 80................................. 14,080 measuring absorbency--801.430(f). Latex condoms; justification for the 51 3.65 186 1.................................. 186 application of testing data to the variation of the tested product-- 801.435(g). ----------------------------------------------------------------------------------------------------------------- Total............................. .............. .............. .............. ................................... 3,264,184 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of disclosures Total annual Activity/21 CFR section respondents per disclosures Average burden per disclosure Total hours respondent -------------------------------------------------------------------------------------------------------------------------------------------------------- Contact lens cleaning solution labeling-- 25 8 200 1......................................... 200 800.10(a)(3) and 800.12(c). Liquid ophthalmic preparation labeling-- 25 8 200 1......................................... 200 800.10(b)(2). Manufacturer, packer, or distributor 18,137 7 126,959 1......................................... 126,959 information--801.1. Adequate directions for use--801.5.......... 8,526 6 51,156 22.35..................................... 1,143,337 Statement of identify--801.61............... 8,526 6 51,156 1......................................... 51,156 Declaration of net quantity of contents-- 8,526 6 51,156 1......................................... 51,156 801.62. Prescription device labeling--801.109....... 9,681 6 58,086 17.77..................................... 1,032,188 Retail exemption for prescription devices-- 30,000 667 20,010,000 .25 (15 minutes).......................... 5,002,500 801.110. Processing, labeling, or repacking; non- 453 34 15,402 4......................................... 61,608 sterile devices--801.150(e). Labeling of articles intended for lay use in 35 1 35 4......................................... 140 the repairing and/or refitting of dentures-- 801.405(b)(1). Dentures; information regarding temporary 35 1 35 4......................................... 140 and emergency use--801.405(c). Labeling requirements for hearing aids-- 124 12 1,488 40........................................ 59,520 801.420(c)(1). Technical Data for hearing aids-- 124 12 1,488 80........................................ 119,040 801.420(c)(4). Hearing aids, opportunity to review User 10,000 160 1,600,000 .30 (20 minutes).......................... 480,000 Instructional Brochure--801.421(b). Hearing aids, availability of User 10,000 5 50,000 .17 (10 minutes).......................... 8,500 Instructional Brochure--801.421(c). User labeling for menstrual tampons-- 16 8 128 2......................................... 256 801.430(d). [[Page 7732]] Menstrual tampons, ranges of absorbency-- 16 8 128 2......................................... 256 801.430(e)(2). User labeling for latex condoms--801.435(b), 51 6 306 100....................................... 30,600 (c), and (h). Labeling for IVDs--809.10(a) and (b)........ 1,700 6 10,200 80........................................ 816,000 Labeling for general purpose laboratory 300 2 600 40........................................ 24,000 reagents--809.10(d)(1). Labeling for analyte specific reagents-- 300 25 7,500 1......................................... 7,500 809.10(e). Labeling for OTC test sample collection 20 1 20 100....................................... 2,000 systems for drugs of abuse testing-- 809.10(f). Advertising and promotional materials for 300 25 7,500 1......................................... 7,500 ASRs--809.30(d). Labeling of sunlamp products--1040.20(d).... 19 1 19 10........................................ 190 ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 9,024,946 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The number of recordkeepers/respondents and records/disclosures has been adjusted to reflect updated Agency data. These adjustments result in an increase of 1,598,48 hours since the last OMB approval. Dated: February 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03608 Filed 2-21-18; 8:45 am] BILLING CODE 4164-01-P
![7728 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
more information about FDA’s posting orally or in writing, on issues pending DEPARTMENT OF HEALTH AND
of comments to public dockets, see 80 before the committee. All electronic and HUMAN SERVICES
FR 56469, September 18, 2015, or access written submissions submitted to the
the information at: https://www.gpo.gov/ docket (see ADDRESSES) on or before Food and Drug Administration
fdsys/pkg/FR-2015-09-18/pdf/2015- April 5, 2018, will be provided to the [Docket No. FDA–2014–N–1048]
23389.pdf. committee. Oral presentations from the
Docket: For access to the docket to public will be scheduled between Agency Information Collection
read background documents or the approximately 10:30 a.m. and 11:30 a.m. Activities; Proposed Collection;
electronic and written/paper comments Those individuals interested in making Comment Request; Medical Device
received, go to https:// formal oral presentations should notify Labeling Regulations
www.regulations.gov and insert the the contact person and submit a brief
docket number, found in brackets in the AGENCY: Food and Drug Administration,
statement of the general nature of the HHS.
heading of this document, into the
evidence or arguments they wish to ACTION: Notice.
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management present, the names and addresses of
proposed participants, and an SUMMARY: The Food and Drug
Staff, 5630 Fishers Lane, Rm. 1061, Administration (FDA or Agency) is
Rockville, MD 20852. indication of the approximate time
requested to make their presentation on announcing an opportunity for public
FOR FURTHER INFORMATION CONTACT: comment on the proposed collection of
Moon Hee V. Choi, Center for Drug or before March 28, 2018. Time allotted
for each presentation may be limited. If certain information by the Agency.
Evaluation and Research, Food and Under the Paperwork Reduction Act of
Drug Administration, 10903 New the number of registrants requesting to
1995 (PRA), Federal Agencies are
Hampshire Ave., Bldg. 31, Rm. 2417, speak is greater than can be reasonably required to publish notice in the
Silver Spring, MD 20993–0002, 301– accommodated during the scheduled Federal Register concerning each
796–9001, Fax: 301–847–8533, email: open public hearing session, FDA may proposed collection of information,
PCNS@fda.hhs.gov, or FDA Advisory conduct a lottery to determine the including each proposed extension of an
Committee Information Line, 1–800– speakers for the scheduled open public existing collection of information, and
741–8138 (301–443–0572 in the hearing session. The contact person will to allow 60 days for public comment in
Washington, DC area). A notice in the notify interested persons regarding their response to the notice. This notice
Federal Register about last minute request to speak by March 29, 2018. solicits comments on Medical Device
modifications that impact a previously Persons attending FDA’s advisory Labeling Regulations.
announced advisory committee meeting committee meetings are advised that DATES: Submit either electronic or
cannot always be published quickly FDA is not responsible for providing written comments on the collection of
enough to provide timely notice. access to electrical outlets. information by April 23, 2018.
Therefore, you should always check the ADDRESSES: You may submit comments
FDA’s website at https://www.fda.gov/ For press inquiries, please contact the
Office of Media Affairs at fdaoma@ as follows. Please note that late,
AdvisoryCommittees/default.htm and untimely filed comments will not be
scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540.
considered. Electronic comments must
committee meeting link, or call the FDA welcomes the attendance of the be submitted on or before April 23,
advisory committee information line to public at its advisory committee 2018. The https://www.regulations.gov
learn about possible modifications meetings and will make every effort to electronic filing system will accept
before coming to the meeting. accommodate persons with disabilities. comments until midnight Eastern Time
SUPPLEMENTARY INFORMATION: If you require accommodations due to a at the end of April 23, 2018. Comments
Agenda: The committee will discuss disability, please contact Moon Hee V. received by mail/hand delivery/courier
new drug application (NDA) 210365, Choi (see FOR FURTHER INFORMATION (for written/paper submissions) will be
cannabidiol oral solution, sponsored by CONTACT) at least 7 days in advance of considered timely if they are
GW Pharmaceuticals, for the adjunctive the meeting. postmarked or the delivery service
treatment of seizures associated with acceptance receipt is on or before that
Lennox-Gastaut syndrome or Dravet FDA is committed to the orderly
conduct of its advisory committee date.
syndrome in patients 2 years of age and
older. meetings. Please visit our website at Electronic Submissions
FDA intends to make background https://www.fda.gov/ Submit electronic comments in the
material available to the public no later AdvisoryCommittees/ following way:
than 2 business days before the meeting. AboutAdvisoryCommittees/ • Federal eRulemaking Portal:
If FDA is unable to post the background ucm111462.htm for procedures on https://www.regulations.gov. Follow the
material on its website prior to the public conduct during advisory instructions for submitting comments.
meeting, the background material will committee meetings. Comments submitted electronically,
be made publicly available at the Notice of this meeting is given under including attachments, to https://
location of the advisory committee the Federal Advisory Committee Act (5 www.regulations.gov will be posted to
meeting, and the background material U.S.C. app. 2). the docket unchanged. Because your
will be posted on FDA’s website after comment will be made public, you are
the meeting. Background material is Dated: February 15, 2018. solely responsible for ensuring that your
daltland on DSKBBV9HB2PROD with NOTICES
available at https://www.fda.gov/ Leslie Kux, comment does not include any
AdvisoryCommittees/Calendar/ Associate Commissioner for Policy. confidential information that you or a
default.htm. Scroll down to the [FR Doc. 2018–03603 Filed 2–21–18; 8:45 am] third party may not wish to be posted,
appropriate advisory committee meeting BILLING CODE 4164–01–P
such as medical information, your or
link. anyone else’s Social Security number, or
Procedure: Interested persons may confidential business information, such
present data, information, or views, as a manufacturing process. Please note
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![7732 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
Number of disclosures Total annual Average burden per
Activity/21 CFR section Total hours
respondents per disclosures disclosure
respondent
Menstrual tampons, ranges of absorbency— 16 8 128 2 ................................ 256
801.430(e)(2).
User labeling for latex condoms—801.435(b), (c), 51 6 306 100 ............................ 30,600
and (h).
Labeling for IVDs—809.10(a) and (b) ..................... 1,700 6 10,200 80 .............................. 816,000
Labeling for general purpose laboratory reagents— 300 2 600 40 .............................. 24,000
809.10(d)(1).
Labeling for analyte specific reagents—809.10(e) .. 300 25 7,500 1 ................................ 7,500
Labeling for OTC test sample collection systems 20 1 20 100 ............................ 2,000
for drugs of abuse testing—809.10(f).
Advertising and promotional materials for ASRs— 300 25 7,500 1 ................................ 7,500
809.30(d).
Labeling of sunlamp products—1040.20(d) ............. 19 1 19 10 .............................. 190
Total .................................................................. ........................ ........................ ........................ .................................... 9,024,946
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of recordkeepers/ incorrect may submit either electronic as a manufacturing process. Please note
respondents and records/disclosures has or written comments and ask for a that if you include your name, contact
been adjusted to reflect updated Agency redetermination by April 23, 2018. information, or other information that
data. These adjustments result in an Furthermore, any interested person may identifies you in the body of your
increase of 1,598,48 hours since the last petition FDA for a determination comments, that information will be
OMB approval. regarding whether the applicant for posted on https://www.regulations.gov.
Dated: February 14, 2018. extension acted with due diligence • If you want to submit a comment
Leslie Kux,
during the regulatory review period by with confidential information that you
August 21, 2018. See ‘‘Petitions’’ in the do not wish to be made available to the
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION section for public, submit the comment as a
[FR Doc. 2018–03608 Filed 2–21–18; 8:45 am]
more information. written/paper submission and in the
BILLING CODE 4164–01–P
ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper
as follows. Please note that late, Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND untimely filed comments will not be Written/Paper Submissions
HUMAN SERVICES considered. Electronic comments must
be submitted on or before April 23, Submit written/paper submissions as
Food and Drug Administration 2018. The https://www.regulations.gov follows:
electronic filing system will accept • Mail/Hand delivery/Courier (for
[Docket Nos. FDA–2015–E–4674, FDA– written/paper submissions): Dockets
2015–E–4696, FDA–2015–E–4700, FDA–
comments until midnight Eastern Time
2015–E–4703, and FDA–2015–E–4704] at the end of April 23, 2018. Comments Management Staff (HFA–305), Food and
received by mail/hand delivery/courier Drug Administration, 5630 Fishers
Determination of Regulatory Review (for written/paper submissions) will be Lane, Rm. 1061, Rockville, MD 20852.
Period for Purposes of Patent considered timely if they are • For written/paper comments
Extension; ESBRIET postmarked or the delivery service submitted to the Dockets Management
acceptance receipt is on or before that Staff, FDA will post your comment, as
AGENCY: Food and Drug Administration, date. well as any attachments, except for
HHS. information submitted, marked and
ACTION: Notice. Electronic Submissions
identified, as confidential, if submitted
Submit electronic comments in the as detailed in ‘‘Instructions.’’
SUMMARY: The Food and Drug following way: Instructions: All submissions received
Administration (FDA or the Agency) has • Federal eRulemaking Portal: must include the Docket Nos. FDA–
determined the regulatory review period https://www.regulations.gov. Follow the 2015–E–4674, FDA–2015–E–4696,
for ESBRIET and is publishing this instructions for submitting comments. FDA–2015–E–4700, FDA–2015–E–4703,
notice of that determination as required Comments submitted electronically, and FDA–2015–E–4704 for
by law. FDA has made the including attachments, to https:// ‘‘Determination of Regulatory Review
determination because of the www.regulations.gov will be posted to Period for Purposes of Patent Extension;
submission of applications to the the docket unchanged. Because your ESBRIET.’’ Received comments, those
Director of the U.S. Patent and comment will be made public, you are filed in a timely manner (see
daltland on DSKBBV9HB2PROD with NOTICES
Trademark Office (USPTO), Department solely responsible for ensuring that your ADDRESSES), will be placed in the
of Commerce, for the extension of a comment does not include any dockets and, except for those submitted
patent which claims that human drug confidential information that you or a as ‘‘Confidential Submissions,’’ publicly
product. third party may not wish to be posted, viewable at https://www.regulations.gov
DATES: Anyone with knowledge that any such as medical information, your or or at the Dockets Management Staff
of the dates as published (in the anyone else’s Social Security number, or between 9 a.m. and 4 p.m., Monday
SUPPLEMENTARY INFORMATION section) are confidential business information, such through Friday.
VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1](https://thefederalregister.org/doc/83_FR_7764/page/5.svg)
Document Created: 2018-02-22 02:50:53
Document Modified: 2018-02-22 02:50:53
| 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 April 23, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 7728 |
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