83 FR 44884 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 171 (September 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 171 (September 4, 2018)
| Page Range | 44884-44887 | |
| FR Document | 2018-19086 |
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)] [Notices] [Pages 44884-44887] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19086] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1048] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 4, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0485. Also include the FDA docket number found in brackets in the heading of this document. 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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 [[Page 44885]] 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 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 [[Page 44886]] 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 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. In the Federal Register of February 22, 2018 (83 FR 7728), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment regarding environmental concerns. We believe this issue is beyond the scope of this information request. 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, shipping 1,119 47,050 52,648,950 0.0008 (.05 minutes)....................... 42,119 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). [[Page 44887]] Labeling of articles intended for lay use 35 1 35 4.......................................... 140 in 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........................................ 8,500 Instructional Brochure--801.421(c). (10 minutes)............................... User labeling for menstrual tampons-- 16 8 128 2.......................................... 256 801.430(d). Menstrual tampons, ranges of absorbency-- 16 8 128 2.......................................... 256 801.430(e)(2). User labeling for latex condoms-- 51 6 306 100........................................ 30,600 801.435(b), (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 ASRs--809.10(e)............... 300 25 7,500 1.......................................... 7,500 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: August 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19086 Filed 8-31-18; 8:45 am] BILLING CODE 4164-01-P
![44884 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
fdsys/pkg/FR-2015-09-18/pdf/2015- including, but not limited to, INDs, Office of Management and Budget
23389.pdf. NDAs, BLAs, and ANDAs. This (OMB) for review and clearance under
Docket: For access to the docket to guidance does not address the Paperwork Reduction Act of 1995.
read background documents or the methodological considerations and best DATES: Fax written comments on the
electronic and written/paper comments practices for the conduct of PBPK collection of information by October 4,
received, go to https:// modeling and simulation or the 2018.
www.regulations.gov and insert the appropriateness of PBPK analyses for a ADDRESSES: To ensure that comments on
docket number, found in brackets in the particular drug or a drug product. the information collection are received,
heading of this document, into the This guidance is being issued OMB recommends that written
‘‘Search’’ box and follow the prompts consistent with FDA’s good guidance comments be faxed to the Office of
and/or go to the Dockets Management practices regulation (21 CFR 10.115). Information and Regulatory Affairs,
Staff, 5630 Fishers Lane, Rm. 1061, The guidance represents the current OMB, Attn: FDA Desk Officer, Fax: 202–
Rockville, MD 20852. thinking of FDA on ‘‘Physiologically 395–7285, or emailed to oira_
You may submit comments on any Based Pharmacokinetic Analyses— submission@omb.eop.gov. All
guidance at any time (see 21 CFR Format and Content.’’ It does not comments should be identified with the
10.115(g)(5)). establish any rights for any person and OMB control number 0910–0485. Also
Submit written requests for single is not binding on FDA or the public. include the FDA docket number found
copies of this guidance to the Division You can use an alternative approach if in brackets in the heading of this
of Drug Information, Center for Drug it satisfies the requirements of the document.
Evaluation and Research, Food and applicable statutes and regulations. This
Drug Administration, 10001 New guidance is not subject to Executive FOR FURTHER INFORMATION CONTACT:
Hampshire Ave., Hillandale Building, Order 12866. Amber Sanford, Office of Operations,
4th Floor, Silver Spring, MD 20993– Food and Drug Administration, Three
II. Paperwork Reduction Act of 1995 White Flint North, 10A–12M, 11601
0002. Send one self-addressed adhesive
label to assist that office in processing This guidance refers to previously Landsdown St., North Bethesda, MD
your requests. See the SUPPLEMENTARY approved collections of information 20852, 301–796–8867, PRAStaff@
INFORMATION section for electronic found in FDA regulations. These fda.hhs.gov.
access to the guidance document. collections of information are subject to SUPPLEMENTARY INFORMATION: In
FOR FURTHER INFORMATION CONTACT:
review by the Office of Management and compliance with 44 U.S.C. 3507, FDA
Xinyuan Zhang, Office of Clinical Budget (OMB) under the Paperwork has submitted the following proposed
Pharmacology, Office of Translational Reduction Act of 1995 (44 U.S.C. 3501– collection of information to OMB for
Sciences, Center for Drug Evaluation 3520). The collection of information in review and clearance.
and Research, Food and Drug 21 CFR 314.50(d) has been approved
under OMB control number 0910–0001. Medical Device Labeling Regulations—
Administration, 10903 New Hampshire 21 CFR Parts 800, 801, and 809
Ave., Bldg. 51, Rm. 2128, Silver Spring, III. Electronic Access
MD 20993–0002, 240–402–7971. OMB Control Number 0910–0485—
Persons with access to the internet
SUPPLEMENTARY INFORMATION: Extension
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance Section 502 of the Federal Food, Drug,
I. Background
ComplianceRegulatoryInformation/ and Cosmetic Act (FD&C Act) (21 U.S.C.
FDA is announcing the availability of Guidances/default.htm or https:// 352), among other things, establishes
a final guidance for industry entitled www.regulations.gov. requirements for the label or labeling of
‘‘Physiologically Based Pharmacokinetic a medical device so that it is not
Dated: August 27, 2018.
Analyses—Format and Content.’’ A misbranded and subject to a regulatory
PBPK analysis uses models and Leslie Kux,
action. Certain provisions under section
simulations that combine physiology, Associate Commissioner for Policy. 502 of the FD&C Act require
population, and drug characteristics to [FR Doc. 2018–19065 Filed 8–31–18; 8:45 am] manufacturers, importers, and
mechanistically describe the BILLING CODE 4164–01–P distributors of medical devices to
pharmacokinetic behaviors of a drug or disclose information about themselves
drug product. Throughout a drug’s life or the devices on the labels or labeling
cycle, PBPK model predictions can be DEPARTMENT OF HEALTH AND for the devices.
used to support decisions on whether, HUMAN SERVICES Section 502(b) of the FD&C Act
when, and how to conduct certain requires that for packaged devices, the
Food and Drug Administration
clinical pharmacology studies, and to label must bear the name and place of
support dosing recommendations in [Docket No. FDA–2014–N–1048] business of the manufacturer, packer, or
product labeling. Because of the lack of distributor; and an accurate statement of
regulatory guidance, the format and Agency Information Collection the quantity of the contents. Section
content of PBPK analysis reports that Activities; Submission for Office of 502(f) of the FD&C Act requires that the
are submitted to FDA vary significantly. Management and Budget Review; labeling for a device must contain
The goal of this guidance is to Comment Request; Medical Device adequate directions for use. FDA may,
standardize the content and format of Labeling Regulations however, grant an exemption if the
these reports to facilitate FDA’s efficient
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Food and Drug Administration, Agency determines that the adequate
assessment, consistent application, and HHS. directions for use labeling requirements
timely decision making during ACTION: Notice. are not necessary for the particular case
regulatory review. as it relates to protection of the public
This guidance outlines the SUMMARY: The Food and Drug health.
recommended format and content for a Administration (FDA) is announcing FDA regulations under parts 800, 801,
sponsor or applicant to submit PBPK that a proposed collection of and 809 (21 CFR parts 800, 801, and
analyses to FDA to support applications information has been submitted to the 809) require disclosure of specific
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![Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 44887
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Total Average
Number of disclosures Total
Activity/21 CFR section annual burden per
respondents per hours
disclosures disclosure
respondent
Labeling of articles intended for lay use in the re- 35 1 35 4 .................................. 140
pairing and/or refitting of dentures—
801.405(b)(1).
Dentures; information regarding temporary and 35 1 35 4 .................................. 140
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—801.420(c)(4) .... 124 12 1,488 80 ................................ 119,040
Hearing aids, opportunity to review User Instruc- 10,000 160 1,600,000 .30 (20 minutes) .......... 480,000
tional Brochure—801.421(b).
Hearing aids, availability of User Instructional Bro- 10,000 5 50,000 .17 ............................... 8,500
chure—801.421(c). (10 minutes) ................
User labeling for menstrual tampons—801.430(d) 16 8 128 2 .................................. 256
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 re- 300 2 600 40 ................................ 24,000
agents—809.10(d)(1).
Labeling for ASRs—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/ determined that it is in the public relate to helping to ensure safe and
respondents and records/disclosures has interest to renew the Cardiovascular and effective drugs for human use and, as
been adjusted to reflect updated Agency Renal Drugs Advisory Committee for an required, any other product for which
data. These adjustments result in an additional 2 years beyond the charter FDA has regulatory responsibility.
increase of 1,598,48 hours since the last expiration date. The new charter will be The committee reviews and evaluates
OMB approval. in effect until August 27, 2020. available data concerning the safety and
Dated: August 28, 2018. DATES: Authority for the Cardiovascular effectiveness of marketed and
and Renal Drugs Advisory Committee investigational human drug products for
Leslie Kux,
will expire on August 27, 2020, unless use in the treatment of cardiovascular
Associate Commissioner for Policy.
the Commissioner formally determines and renal disorders and makes
[FR Doc. 2018–19086 Filed 8–31–18; 8:45 am] appropriate recommendations to the
BILLING CODE 4164–01–P
that renewal is in the public interest.
Commissioner.
FOR FURTHER INFORMATION CONTACT: The committee shall consist of a core
Jennifer Shepherd, Center for Drug of 11 voting members including the
DEPARTMENT OF HEALTH AND Evaluation and Research, Food and Chair. Members and the Chair are
HUMAN SERVICES Drug Administration, 10903 New selected by the Commissioner or
Hampshire Ave., Bldg. 31, Rm. 2417, designee from among authorities
Food and Drug Administration Silver Spring, MD 20993–0002, 301– knowledgeable in the fields of
[Docket No. FDA–2018–N–3091] 796–9001, email: CRDAC@fda.hhs.gov. cardiology, hypertension, arrhythmia,
SUPPLEMENTARY INFORMATION: Pursuant angina, congestive heart failure,
Advisory Committee; Cardiovascular to 41 CFR 102–3.65 and approval by the diuresis, and biostatistics. Members will
and Renal Drugs Advisory Committee; Department of Health and Human be invited to serve for overlapping terms
Renewal Services pursuant to 45 CFR part 11 and of up to 4 years. Almost all non-Federal
AGENCY: Food and Drug Administration, by the General Services Administration, members of this committee serve as
HHS. FDA is announcing the renewal of the Special Government Employees. The
ACTION:Notice; renewal of advisory Cardiovascular and Renal Drugs core of voting members may include one
Advisory Committee. The committee is technically qualified member, selected
sradovich on DSK3GMQ082PROD with NOTICES
committee.
a discretionary Federal advisory by the Commissioner or designee, who
SUMMARY: The Food and Drug committee established to provide advice is identified with consumer interests
Administration (FDA) is announcing the to the Commissioner. and is recommended by either a
renewal of the Cardiovascular and Renal The Cardiovascular and Renal Drugs consortium of consumer-oriented
Drugs Advisory Committee by the Advisory Committee advises the organizations or other interested
Commissioner of Food and Drugs (the Commissioner or designee in persons. In addition to the voting
Commissioner). The Commissioner has discharging responsibilities as they members, the committee may include
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Document Created: 2018-09-01 02:59:15
Document Modified: 2018-09-01 02:59:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by October 4, 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 44884 |
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